NCIt Subset Code	CDRH Subset Name	NCIt Concept Code	NCIt Preferred Term	NCIt Definition	CDRH Preferred Term	CDRH Source Code	CDRH Definition	IMDRF Code
C54451	CDRH Medical Device Problem Code Terminology	C133496	Patient-Device Interaction Problem	Problem related to the interaction between the patient and a medical device.	Patient Device Interaction Problem	4001	Problem related to the interaction between the patient and the device.	IMDRF:A01
C54451	CDRH Medical Device Problem Code Terminology	C62919	Patient-Device Incompatibility	Problem associated with the interaction between the patient's physiology or anatomy and the device that affects the patient and/or the device.	Patient-Device Incompatibility	2682	Problem associated with the interaction between the patient's physiology or anatomy and the device that affects the patient and/or the device.	IMDRF:A0101
C54451	CDRH Medical Device Problem Code Terminology	C63294	Biocompatibility	Problem associated with undesirable local or systemic effects due to exposure to device materials or leachates from those materials by a patient who has an implant or is receiving treatment with a device made from them.	Biocompatibility	2886	Problem associated with undesirable local or systemic effects due to exposure to medical device materials or leachates from those materials by a patient who has an implant or is receiving treatment with a device made from them.	IMDRF:A010101
C54451	CDRH Medical Device Problem Code Terminology	C62853	Device Appears to Trigger Rejection	The device appears to elicit undesired response in the patient to the presence of an implanted or invasive device, without inherent device failure, e.g. fibrous encapsulation, or inflammation of the tissue around the device, or extrusion of the device.	Device Appears to Trigger Rejection	1524	The device appears to elicit undesired response in the patient to the presence of an implanted or invasive device, without inherent device failure, e.g. fibrous encapsulation, or inflammation of the tissue around the device, or extrusion of the device.	IMDRF:A010102
C54451	CDRH Medical Device Problem Code Terminology	C62947	Inadequacy of Device Shape and/or Size	The physical size and/or shape of the device was inadequate with regard to the patient's anatomy.	Inadequacy of Device Shape and/or Size	1583	The physical size and/or shape of the device was inadequate with regard to the patient's anatomy.	IMDRF:A010103
C54451	CDRH Medical Device Problem Code Terminology	C62886	Osseointegration Problem	Problem associated with interconnection between the bone tissue and the implanted device.	Osseointegration Problem	3003	Problem associated with interconnection between the bone tissue and the implanted device.	IMDRF:A0102
C54451	CDRH Medical Device Problem Code Terminology	C63171	Failure to Osseointegrate	Problem associated with the failure to see direct anchorage of an implant by the formation of bony tissue around the implant without the growth of fibrous tissue at the bone-implant interface.	Failure to Osseointegrate	1863	Problem associated with the failure to see direct anchorage of an implant by the formation of bony tissue around the implant without the growth of fibrous tissue at the bone-implant interface.	IMDRF:A010201
C54451	CDRH Medical Device Problem Code Terminology	C63053	Loss of Osseointegration	Problem associated with weakened integration of the device at the bone-implant interface due to loss of fibrous and/or bony tissue and leading to compromised anchorage of the device. i.e. 'Loosening/Lysis.'	Loss of Osseointegration	2408	Problem associated with weakened integration of the device at the bone-implant interface due to loss of fibrous and/or bony tissue and leading to compromised anchorage of the device. i.e. Loosening/Lysis	IMDRF:A010202
C54451	CDRH Medical Device Problem Code Terminology	C133497	Loosening of Implant Not Related to Bone-Ingrowth	Problem associated with the loss of direct anchorage of an implanted device over time or due to an injury.	Loosening of Implant Not Related to Bone-Ingrowth	4002	Problem associated with the loss of direct anchorage of an implanted device over time or due to an injury.	IMDRF:A0103
C54451	CDRH Medical Device Problem Code Terminology	C62917	Migration or Expulsion of Device	Problem with an implanted or invasive device moving within the body, or being completely expelled from the body.	Migration or Expulsion of Device	1395	Problem with an implanted or invasive device moving within the body, or being completely expelled from the body.	IMDRF:A0104
C54451	CDRH Medical Device Problem Code Terminology	C50554	Expulsion	Problem with all or part of an implanted or invasive medical device being completely expelled from its intended location within the body.	Expulsion	2933	Problem with all or part of an implanted or invasive device being completely expelled from its intended location within the body.	IMDRF:A010401
C54451	CDRH Medical Device Problem Code Terminology	C133722	Device Migration Problem	Problem with all or part of an implanted or invasive device moving from its intended location within the body.	Migration	4003	Problem with all or part of an implanted or invasive device moving from its intended location within the body.	IMDRF:A010402
C54451	CDRH Medical Device Problem Code Terminology	C187247	Lack of Effect	Problems associated with a product having less efficacy than expected. No other malfunctions could be identified.	Lack of Effect	4065	Problems associated with a product having less efficacy than expected. No other malfunctions could be identified.	IMDRF:A0105
C54451	CDRH Medical Device Problem Code Terminology	C187248	Device Stenosis	Problem associated with the narrowing or obstruction of the device (e.g. prosthetic heart valves, stents, etc.).	Device Stenosis	4066	Problem associated with the narrowing or obstruction of the device (e.g. prosthetic heart valves, stents, etc.).	IMDRF:A0106
C54451	CDRH Medical Device Problem Code Terminology	C63041	Manufacturing, Packaging or Shipping Problem	Problem associated with any deviations from the documented specifications of the device that relate to nonconformity during manufacture to the design of an item or to specified manufacturing, packaging or shipping processes (out of box problem).	Manufacturing, Packaging or Shipping Problem	2975	Problem associated with any deviations from the documented specifications of the device that relate to nonconformity during manufacture to the design of an item or to specified manufacturing, packaging or shipping processes (out of box problem).	IMDRF:A02
C54451	CDRH Medical Device Problem Code Terminology	C62948	Device or Device Quality Issue	A difficulty with the quality of part of the device or the device itself.	Product Quality Problem	1506	Problem associated with an inherent device characteristic that is not satisfactory as specified or delivered.	IMDRF:A0201
C54451	CDRH Medical Device Problem Code Terminology	C63219	Dull Device	Problem associated with a device not being as sharp as intended or expected.	Dull, Blunt	2407	Problem associated with a device not being as sharp as intended or expected.	IMDRF:A020101
C54451	CDRH Medical Device Problem Code Terminology	C62898	Nonstandard Device	Problem associated with the device that does not meet the specifications or requirements for which it was manufactured (e.g. materials, parts, manufacturing process).	Nonstandard Device	1420	Problem associated with the device that does not meet the specifications or requirements for which it was manufactured (e.g. materials, parts, manufacturing process).	IMDRF:A020102
C54451	CDRH Medical Device Problem Code Terminology	C63023	Defective Component	Problem associated with a device component having flaws of dimensional deviations greater than acceptable for the intended use.	Defective Component	2292	Problem associated with a device component having flaws of dimensional deviations greater than acceptable for the intended use.	IMDRF:A0202
C54451	CDRH Medical Device Problem Code Terminology	C63250	Defective Device	Problem associated with having flaws or dimensional deviations greater than acceptable for the intended use of the device.	Defective Device	2588	Problem associated with having flaws or dimensional deviations greater than acceptable for the intended use of the device.	IMDRF:A0203
C54451	CDRH Medical Device Problem Code Terminology	C63015	Device Damaged Prior to Use	Problem associated with packaging or shipping damage prior to the use of a device.	Device Damaged Prior to Use	2284	Problem associated with packaging or shipping damage prior to the use of the device.	IMDRF:A0204
C54451	CDRH Medical Device Problem Code Terminology	C62939	Packaging Problem	Problem associated with the materials used to construct the cover or outer wrapping of the device.	Packaging Problem	3007	Problem associated with the materials used to construct the cover or outer wrapping of the device.	IMDRF:A0205
C54451	CDRH Medical Device Problem Code Terminology	C63231	Difficult to Open or Remove Packaging Material	Problem associated with difficulty for users to operate the device, specifically as it relates to the opening or removal of the outer wrapping.	Difficult to Open or Remove Packaging Material	2922	Problem associated with difficulty for users to operate the device, specifically as it relates to the opening or removal of the outer wrapping.	IMDRF:A020501
C54451	CDRH Medical Device Problem Code Terminology	C62940	Packaging Incomplete or Missing	Problem associated with the nonconformance to the device specifications due to incomplete or missing packaging that may compromise the device operation as intended.	Incomplete or Missing Packaging	2312	Problem associated with the nonconformance to the device specifications due to incomplete or missing packaging that may compromise the device operation as intended.	IMDRF:A020502
C54451	CDRH Medical Device Problem Code Terminology	C62810	Unsealed Device Packaging	Problem associated with the device's loss of packaging seal.	Unsealed Device Packaging	1444	Problem associated with the loss of packaging seal.	IMDRF:A020503
C54451	CDRH Medical Device Problem Code Terminology	C62831	Tear, Rip or Hole in Packaging	Problem associated with packaging damage (tear, rip or hole) prior to the use of the device.	Tear, Rip or Hole in Device Packaging	2385	Problem associated with packaging damage (tear, rip or hole) prior to the use of the device.	IMDRF:A020504
C54451	CDRH Medical Device Problem Code Terminology	C62957	Device Misassembled during Manufacturing or Shipping	A device found incorrectly assembled when delivered to the user facility.	Device Misassembled During Manufacturing /Shipping	2912	A device found incorrectly assembled when delivered to the user facility.	IMDRF:A0206
C54451	CDRH Medical Device Problem Code Terminology	C133498	Component Misassembled	A device is found to have one or more components incorrectly assembled when delivered to the user facility.	Component Misassembled	4004	A device found to have one or more components incorrectly assembled when delivered to the user facility. This includes cases in which components are interchanged.	IMDRF:A020601
C54451	CDRH Medical Device Problem Code Terminology	C63021	Component Missing	A device component(s) found to be missing when delivered to the user facility.	Component Missing	2306	A device component(s) found to be missing when delivered to the user facility.	IMDRF:A020602
C54451	CDRH Medical Device Problem Code Terminology	C187249	Extra Component	More than the usual number of components present/additional components from this or other devices.	Extra Components	4067	More than the usual number of components present/additional components from this or other devices.	IMDRF:A020603
C54451	CDRH Medical Device Problem Code Terminology	C62925	Shipping Damage or Problem	Problem associated with shipping damage or problem prior to the use of the device.	Shipping Damage or Problem	1570	Problem associated with shipping damage or problem prior to the use of the device.	IMDRF:A0207
C54451	CDRH Medical Device Problem Code Terminology	C63014	Delivered As Unsterile Product	Problem associated with a device being received in such a manner to indicate that its sterility has been compromised (e.g. sterile packaging breached, visible contaminate present).	Delivered as Unsterile Product	1421	Problem associated with a device being received in such a manner to indicate that its sterility has been compromised (e.g. sterile packaging breached, visible contaminate present)	IMDRF:A020701
C54451	CDRH Medical Device Problem Code Terminology	C62945	Chemical Problem	Problem associated with any from the documented specifications of a device that relate to any chemical characterization, i.e., element, compound, or mixture.	Chemical Problem	2893	Problem associated with any from the documented specifications of the device that relate to any chemical characterization, i.e., element, compound, or mixture.	IMDRF:A03
C54451	CDRH Medical Device Problem Code Terminology	C63004	Device Emits Odor	Problem associated with an unexpected or inappropriate smell released by the device.	Device Emits Odor	1425	Problem associated with an unexpected or inappropriate smell released by the device.	IMDRF:A0301
C54451	CDRH Medical Device Problem Code Terminology	C62982	Device Ingredient or Reagent Problem	Problem associated with any deviations from the documented specifications of the device that relate to any ingredient or reagent characterization.	Device Ingredient or Reagent Problem	2910	Problem associated with any deviations from the documented specifications of the device that relate to any ingredient or reagent characterization.	IMDRF:A0302
C54451	CDRH Medical Device Problem Code Terminology	C63275	Clumping in Device or Device Ingredient	Problem associated with the aggregation of particles into irregular masses.	Clumping in Device or Device Ingredient	1095	Problem associated with the aggregation of particles into irregular masses.	IMDRF:A030201
C54451	CDRH Medical Device Problem Code Terminology	C63274	Coagulation in Device or Device Ingredient	Problem associated with the undesired characterization of congealing, solidifying, thickening, curdling.	Coagulation in Device or Device Ingredient	1096	Problem associated with the undesired characterization of congealing, solidifying, thickening, curdling.	IMDRF:A030202
C54451	CDRH Medical Device Problem Code Terminology	C62866	Precipitate in Device or Device Ingredient	Problem associated with the separation of solid particles from a liquid as the result of a chemical or physical change.	Precipitate in Device or Device Ingredient	1478	Problem associated with the separation of solid particles from a liquid as the result of a chemical or physical change.	IMDRF:A030203
C54451	CDRH Medical Device Problem Code Terminology	C63261	Cross Reactivity	Problem associated with the degree to which an antibody or antigen participates in cross reactions.	Cross Reactivity	1137	Problem associated with the degree to which an antibody or antigen participates in cross reactions.	IMDRF:A030204
C54451	CDRH Medical Device Problem Code Terminology	C62879	Particulates	Substances that consist of separate particles that are introduced by the device during use.	Particulates	1451	Substances that consist of separate particles that are introduced by the device during use.	IMDRF:A030205
C54451	CDRH Medical Device Problem Code Terminology	C62981	High pH	pH higher than expected and/or anticipated.	High pH	2426	pH higher than expected and/or anticipated.	IMDRF:A030206
C54451	CDRH Medical Device Problem Code Terminology	C133500	Low pH	pH lower than expected and/or anticipated.	Low pH	4005	pH lower than expected and/or anticipated.	IMDRF:A030207
C54451	CDRH Medical Device Problem Code Terminology	C172079	Unexpected Product Color	Color of product is different from that expected.	Unexpected Color	4055	Color of product is different from that expected.	IMDRF:A030208
C54451	CDRH Medical Device Problem Code Terminology	C63111	Improper Chemical Reaction	Problem associated with an unexpected or incomplete chemical reaction or effect.	Improper Chemical Reaction	2952	Problem associated with an unexpected or incomplete chemical reaction or effect.	IMDRF:A0303
C54451	CDRH Medical Device Problem Code Terminology	C62968	Material Integrity Problem	Problem associated with any deviations from the documented specifications of the device that relate to the limited durability of all material used to construct the device.	Material Integrity Problem	2978	Problem associated with any deviations from the documented specifications of the device that relate to the limited durability of all material used to construct device.	IMDRF:A04
C54451	CDRH Medical Device Problem Code Terminology	C62973	Material Break	Problem associated with undesired damage or breakage of those materials used in the device construction.	Break	1069	Problem associated with undesired damage or breakage of those materials used in the device construction.	IMDRF:A0401
C54451	CDRH Medical Device Problem Code Terminology	C63132	Fracture of Device/Material	Problem associated with a partial or full-thickness crack in the device materials.	Fracture	1260	Problem associated with a partial or full-thickness crack in the device materials.	IMDRF:A040101
C54451	CDRH Medical Device Problem Code Terminology	C63194	Loss of or Failure to Bond	Problem associated with lack or loss of adherence between materials intended to be joined together by an adhesive.	Loss of or Failure to Bond	1068	Problem associated with lack or loss of adherence between materials intended to be joined together by an adhesive.	IMDRF:A040102
C54451	CDRH Medical Device Problem Code Terminology	C62969	Material Fragmentation	Problem associated with small pieces of the device breaking off unexpectedly.	Material Fragmentation	1261	Problem associated with small pieces of the device breaking off unexpectedly.	IMDRF:A040103
C54451	CDRH Medical Device Problem Code Terminology	C62838	Solder Joint Failure	Problem associated with undesired damage or breakage in a solder joint of materials used in the device construction.	Solder Joint Fracture	2324	Problem associated with undesired damage or breakage in a solder joint of materials used in the device construction.	IMDRF:A040104
C54451	CDRH Medical Device Problem Code Terminology	C62972	Burst Container or Vessel	Problem associated with the pressure inside a vessel or container rising to such a degree that the container ruptures.	Burst Container or Vessel	1074	Problem associated with the pressure inside a vessel or container rising to such a degree that the container ruptures.	IMDRF:A0402
C54451	CDRH Medical Device Problem Code Terminology	C133505	Device Explosion	Problem with the device associated with the violent bursting due to the sudden expansion of air, gas or fluid.	Explosion	4006	Problem associated with the violent bursting due to the sudden expansion of air, gas or fluid.	IMDRF:A0403
C54451	CDRH Medical Device Problem Code Terminology	C62971	Material Crack	Problem associated with an undesired partial separation and/or a visible opening along the length or width in the materials that are used in the device construction.	Crack	1135	Problem associated with an undesired partial separation and/or a visible opening along the length or width in the materials that are used in the device construction.	IMDRF:A0404
C54451	CDRH Medical Device Problem Code Terminology	C62970	Degradation	Problem associated with a undesired change in the chemical structure, physical properties, or appearance in the materials that are used in the device construction.	Degraded	1153	Problem associated with a undesired change in the chemical structure, physical properties, or appearance in the materials that are used in the device construction.	IMDRF:A0405
C54451	CDRH Medical Device Problem Code Terminology	C63285	Calcified Material	Problem associated with buildup of calcium salts on a device.	Calcified	1077	Problem associated with buildup of calcium salts on the device.	IMDRF:A040501
C54451	CDRH Medical Device Problem Code Terminology	C63263	Corroded Device	Problem associated with the chemical or electrochemical reaction between materials, usually a metal and its environment that produces a deterioration of the metal and its properties.	Corroded	1131	Problem associated with the chemical or electrochemical reaction between materials, usually a metal and its environment that produces a deterioration of the metal and its properties.	IMDRF:A040502
C54451	CDRH Medical Device Problem Code Terminology	C63208	Material Erosion	Problem associated with a progressive loss of a material from a solid surface.	Material Erosion	1214	Problem associated with a progressive loss of a material from a solid surface.	IMDRF:A040503
C54451	CDRH Medical Device Problem Code Terminology	C62874	Pitted Material	Problem associated with the corrosion of a material's surface, confined to a point or small area that takes the form of cavities.	Pitted	1460	Problem associated with the corrosion of a material's surface, confined to a point or small area that takes the form of cavities.	IMDRF:A040504
C54451	CDRH Medical Device Problem Code Terminology	C63141	Flaked Material	Problem associated with the detachment of small pieces of the coating film of a material.	Flaked	1246	Problem associated with the detachment of small pieces of the coating film of a material.	IMDRF:A040505
C54451	CDRH Medical Device Problem Code Terminology	C62878	Peeled/Delaminated Material	Peeling or delamination of composite materials, including coatings, that occurs when layers are separated as a result of stress or impact and resulting in loss of mechanical toughness.	Peeled/Delaminated	1454	Peeling or delamination of composite materials, including coatings, that occurs when layers are separated as a result of stress or impact and resulting in loss of mechanical toughness.	IMDRF:A040506
C54451	CDRH Medical Device Problem Code Terminology	C62906	Naturally Worn Material	Problem associated with material damage to a surface, usually involving progressive loss or displacement of material, due to relative motion between that surface and a contacting substance or substances.	Naturally Worn	2988	Problem associated with material damage to a surface, usually involving progressive loss or displacement of material, due to relative motion between that surface and a contacting substance or substances.	IMDRF:A040507
C54451	CDRH Medical Device Problem Code Terminology	C62811	Unraveled Material	Problem due to the device's undesired unravelling of material (e.g. disentangled, unwound etc.).	Unraveled Material	1664	Problem due to the undesired unravelling of material (e.g. disentangled, unwound etc.).	IMDRF:A040508
C54451	CDRH Medical Device Problem Code Terminology	C63248	Material Deformation	Problem associated with an undesired material change in shape or property caused by external forces.	Material Deformation	2976	Problem associated with an undesired material change in shape or property caused by external forces.	IMDRF:A0406
C54451	CDRH Medical Device Problem Code Terminology	C63287	Deformation due to Compressive Stress	Problem associated with an undesired bulge, bend, bow, kink, or wavy condition observed in the device material resulting from compressive stresses.	Deformation Due to Compressive Stress	2889	Problem associated with an undesired bulge, bend, bow, kink, or wavy condition observed in the device material resulting from compressive stresses.	IMDRF:A040601
C54451	CDRH Medical Device Problem Code Terminology	C63245	Dent in Material	Problem associated with a undesired change in shape, characterized by the presence of a slight hollow (dent) in the device surface.	Dent in Material	2526	Problem associated with a undesired change in shape, characterized by the presence of a slight hollow (dent) in the device surface.	IMDRF:A040602
C54451	CDRH Medical Device Problem Code Terminology	C63175	Failure to Fold	Problem associated with an undesired material change in the physical property of the device which is characterized by failure to fold.	Failure to Fold	1255	Problem associated with an undesired material change in physical property, characterized by failure to fold.	IMDRF:A040603
C54451	CDRH Medical Device Problem Code Terminology	C62949	Failure to Unfold or Unwrap	Problem associated with the comprising materials' deformation in that device fails to open its wrapping or open/extend in a certain manner i.e. balloon or lens.	Failure to Unfold or Unwrap	1669	Problem associated with the comprising materials' deformation in that device fails to open its wrapping or open/extend in a certain manner i.e. balloon or lens.	IMDRF:A040604
C54451	CDRH Medical Device Problem Code Terminology	C63131	Material Frayed	Problem associated with the comprising materials having damaged edges.	Material Frayed	1262	Problem associated with the comprising materials having damaged edges.	IMDRF:A040605
C54451	CDRH Medical Device Problem Code Terminology	C63063	Material Invagination	Problem associated with an undesired material change in shape, characterized by the infolding of one part within another part of a structure.	Material Invagination	1336	Problem associated with an undesired material change in shape, characterized by the infolding of one part within another part of a structure.	IMDRF:A040606
C54451	CDRH Medical Device Problem Code Terminology	C62847	Material Too Rigid or Stiff	Problem associated with an undesired material change in physical property, characterized by rigidity (it resists deformation in response to an applied force).	Material Too Rigid or Stiff	1544	Problem associated with an undesired material change in physical property, characterized by rigidity (it resists deformation in response to an applied force).	IMDRF:A040607
C54451	CDRH Medical Device Problem Code Terminology	C133507	Material Too Soft or Flexible	Problem associated with the device material that results in the material's inability to maintain the desired shape or support function.	Material Too Soft/Flexible	4007	Problem associated with any device material that results in the material's inability to maintain the desired shape or support function.	IMDRF:A040608
C54451	CDRH Medical Device Problem Code Terminology	C62962	Material Twisted/Bent	Problem associated with deformations that lead to twisting or bending of the device.	Material Twisted/Bent	2981	Problem associated with deformations that lead to twisting or bending of the device.	IMDRF:A040609
C54451	CDRH Medical Device Problem Code Terminology	C62908	Melted Device	Problem associated with a solid device being transformed into a molten or liquid state.	Melted	1385	Problem associated with a solid device being transformed into a molten or liquid state.	IMDRF:A040610
C54451	CDRH Medical Device Problem Code Terminology	C62835	Material Stretched	Problem associated with an increase or elongation in a materials' dimension.	Stretched	1601	Problem associated with an increase or elongation in a materials' dimension.	IMDRF:A040611
C54451	CDRH Medical Device Problem Code Terminology	C172039	Thickening of Device Material	Device is thickened due to deformation.	Thickening of Material	4056	Device is thickened due to deformation. Note: Not to be used for thickening of liquid.	IMDRF:A040612
C54451	CDRH Medical Device Problem Code Terminology	C63224	Discolored Material	Problem associated with an undesired streak, pattern and/or a noticeable change in color from the rest of the materials used in the device construction.	Material Discolored	1170	Problem associated with an undesired streak, pattern and/or a noticeable change in color from the rest of the materials used in the device construction.	IMDRF:A0407
C54451	CDRH Medical Device Problem Code Terminology	C63222	Material Disintegration	Problem associated with material breaking into small pieces.	Material Disintegration	1177	Problem associated with material breaking into small particles.	IMDRF:A0408
C54451	CDRH Medical Device Problem Code Terminology	C62895	Material Opacification	Problem associated with an undesirable opaqueness or cloudiness.	Material Opacification	1426	Problem associated with an undesirable opaqueness or cloudiness.	IMDRF:A0409
C54451	CDRH Medical Device Problem Code Terminology	C62967	Material Perforation	Material constituting device is perforated possibly compromising the device's intended purpose.	Material Perforation	2205	Material constituting device is perforated possibly compromising the device's intended purpose.	IMDRF:A0410
C54451	CDRH Medical Device Problem Code Terminology	C62966	Material Puncture/Hole	Device material(s) punctured leading to undesired holes/openings.	Material Puncture/Hole	1504	Device material(s) punctured leading to undesired holes/openings.	IMDRF:A041001
C54451	CDRH Medical Device Problem Code Terminology	C72891	Material Protrusion	Problem associated with undesired physical appearance of device material, specifically when material extends beyond or above device surface.	Material Protrusion/Extrusion	2979	Problem associated with undesired physical appearance of device material, specifically when material extends beyond or above device surface.	IMDRF:A0411
C54451	CDRH Medical Device Problem Code Terminology	C62965	Material Rupture	Problem associated with perforations that lead to bursting of the device.	Material Rupture	1546	Problem associated with perforations that lead to bursting of the device.	IMDRF:A0412
C54451	CDRH Medical Device Problem Code Terminology	C62964	Material Separation	Problem associated with an undesired disassociation or breaking apart of the device.	Material Separation	1562	Problem associated with an undesired disassociation or breaking apart of the device.	IMDRF:A0413
C54451	CDRH Medical Device Problem Code Terminology	C133509	Material Split, Cut or Torn	Problem associated with materials comprising the device are split, cut or torn due to external forces (e.g. wrenching or laceration) or internal forces (e.g. exceeding the tensile stress limits belonging to the materials used in the device construction).	Material Split, Cut or Torn	4008	Problem associated with materials consisting the device are split, cut or torn due to external forces (e.g. wrenching or laceration) or internal forces (e.g. exceeding the tensile stress limits belonging to the materials used in the device construction).	IMDRF:A0414
C54451	CDRH Medical Device Problem Code Terminology	C62846	Scratched Material	Problem associated with an undesirable shallow cut or narrow groove in the surface of the device materials.	Scratched Material	3020	Problem associated with an undesirable shallow cut or narrow groove in the surface of the device materials.	IMDRF:A0415
C54451	CDRH Medical Device Problem Code Terminology	C62961	Mechanical Issue	Problems associated with mechanical actions or defects of the device, which includes any moving parts or subassemblies, etc.	Mechanical Problem	1384	Problems associated with mechanical actions or defects, including moving parts or subassemblies, etc.	IMDRF:A05
C54451	CDRH Medical Device Problem Code Terminology	C63242	Detachment of Device or Device	Problem associated with the separation of the device from its physical construct, integrity, or chassis.	Detachment of Device or Device Component	2907	Problem associated with the separation of the device from its physical construct, integrity, or chassis.	IMDRF:A0501
C54451	CDRH Medical Device Problem Code Terminology	C62951	Device Damaged by another Device	Problem associated with one device causing harm to another device.	Device Damaged by Another Device	2915	Problem associated with one device causing harm to another device.	IMDRF:A0502
C54451	CDRH Medical Device Problem Code Terminology	C133510	Ejection Problem	Problems associated with the inability of or unexpected removal or separation of the device from its physical location.	Ejection Problem	4009	Problems associated with the inability or unexpected ejection or discharge of the device from its physical location.	IMDRF:A0503
C54451	CDRH Medical Device Problem Code Terminology	C133511	Failure to Eject	Problem associated with the inability to remove or discharge device from the location of use.	Failure to Eject	4010	Problem associated with the inability of the device to be ejected or discharged from its physical location.	IMDRF:A050301
C54451	CDRH Medical Device Problem Code Terminology	C62817	Unintended Ejection	Problem associated with unexpected discharge of the device from expected location includes but not limited to the device such as clip appliers, film cartridge, staples.	Unintended Ejection	1234	Problem associated with unexpected ejection of the device from its physical location. This includes but is not limited to devices such as clip appliers, film cartridge, and staples.	IMDRF:A050302
C54451	CDRH Medical Device Problem Code Terminology	C63058	Leak/Splash	Problem associated with the escape of a liquid or gas from the vessel or container in which it is housed.	Leak/Splash	1354	Problem associated with the escape of a liquid (including blood and bodily fluids), gas or radiation from the vessel or container in which it is housed.	IMDRF:A0504
C54451	CDRH Medical Device Problem Code Terminology	C63137	Fluid/Blood Leak	Escape (Release, Discharge) of fluid (including blood or bodily fluid) through an unintended location; often accompanied by a loss of pressure and/or output. This includes both external and internal fluid leak. This does not include fluidized powder leak.	Fluid/Blood Leak	1250	Escape (Release, Discharge) of fluid (including blood or bodily fluid) through an unintended location; often accompanied by a loss of pressure and/or output. This includes both external and internal fluid leak. This does not include fluidized powder leak.	IMDRF:A050401
C54451	CDRH Medical Device Problem Code Terminology	C63127	Gas/Air Leak	Problem associated with the unintended escape of a gas/air from the container in which it is housed. This also includes both external and internal air/gas leak.	Gas/Air Leak	2946	Problem associated with the unintended escape of a gas/air from the container in which it is housed. This also includes both external and internal air/gas leak.	IMDRF:A050402
C54451	CDRH Medical Device Problem Code Terminology	C63316	Gel Leak	Escape (release, discharge) of gel through an unintended location - as in leakage of ultrasound gel. Escape or release of gel from containment structures - as in gel filled implant leak.	Gel Leak	1267	Escape (Release, Discharge) of gel through an unintended location - as in leakage of ultrasound gel. Escape or release of gel from containment structures - as in gel filled implant leak.	IMDRF:A050403
C54451	CDRH Medical Device Problem Code Terminology	C62857	Radiation Leak	Escape of radiation (energy in the form of waves or subatomic particles, especially those that cause ionization) through containment structures, leading to unintended exposure.	Radiation Leak	1357	Escape of radiation (energy in the form of waves or subatomic particles, especially those that cause ionization) through containment structures, leading to unintended exposure.	IMDRF:A050404
C54451	CDRH Medical Device Problem Code Terminology	C62876	Perivalvular Leak	Problem associated with the escape of blood around a heart valve, particularly around its leaflets.	Perivalvular Leak	1457	Problem associated with the escape of blood around a heart valve, particularly around its leaflets.	IMDRF:A050405
C54451	CDRH Medical Device Problem Code Terminology	C187251	Central Regurgitation Heart Valve	Problem associated with the escape of blood through the center of the heart valve or the backward flow of blood through the heart valve.	Central Regurgitation	4068	Problem associated with the escape of blood through the center of the heart valve or the backward flow of blood through the heart valve.	IMDRF:A050406
C54451	CDRH Medical Device Problem Code Terminology	C187252	Powder Leak	Escape (release, discharge) of powder (including particulates) through an unintended location,  often accompanied by a loss of pressure and/or output.	Powder Leak	4069	Escape (release, discharge) of powder (including particulates) through an unintended location,  often accompanied by a loss of pressure and/or output.	IMDRF:A050407
C54451	CDRH Medical Device Problem Code Terminology	C133512	Firing Problem	Problem associated with the device not discharging as intended.	Firing Problem	4011	Problem associated with the device not discharging as intended.	IMDRF:A0505
C54451	CDRH Medical Device Problem Code Terminology	C63177	Failure to Fire	Problem associated with failure of the device to discharge its load (e.g. surgical stapler failed to partially or completely deploy its staples).	Failure to Fire	2610	Problem associated with failure of the device to discharge its load (e.g. surgical stapler failed to partially or completely deploy its staples).	IMDRF:A050501
C54451	CDRH Medical Device Problem Code Terminology	C62914	Misfire	Issue associated with failure of device to discharge its load (e.g., surgical stapler failed to partially or completely deploy its staples).	Misfire	2532	Problem associated with a therapy or algorithm not being delivered or executed at the expected time.	IMDRF:A050502
C54451	CDRH Medical Device Problem Code Terminology	C63039	Mechanical Jam	The motion of the device is prevented or restricted.	Mechanical Jam	2983	The motion of the device is prevented or restricted.	IMDRF:A0506
C54451	CDRH Medical Device Problem Code Terminology	C62960	Mechanics Altered	Problem associated with a device mechanical functioning of machinery, moving parts or tools of device being changed or modified.	Mechanics Altered	2984	Problem associated with a device mechanical functioning of machinery, moving parts or tools of device being changed or modified.	IMDRF:A0507
C54451	CDRH Medical Device Problem Code Terminology	C63197	Failure to Align	Problem associated with a circuit, equipment, or system whereby its functions fail to be properly synchronized or its relative positions properly oriented.	Failure to Align	2522	Problem associated with a circuit, equipment, or system whereby its functions fail to be properly synchronized or its relative positions properly oriented.	IMDRF:A050701
C54451	CDRH Medical Device Problem Code Terminology	C63188	Failure to Cut	Inability of the device to make an incision, pierce or open as intended.	Failure to Cut	2587	Inability of the device to make an incision, pierce or open as intended.	IMDRF:A050702
C54451	CDRH Medical Device Problem Code Terminology	C63187	Failure to Cycle	Problem associated with the device failing to complete a series of processes or events.	Failure to Cycle	1142	Problem associated with the device failing to complete a series of processes or events.	IMDRF:A050703
C54451	CDRH Medical Device Problem Code Terminology	C64328	Failure to Form Staple	Problem associated with the device failing to connect tissue with a stapling device due to the staples not forming correctly.	Failure to Form Staple	2579	Problem associated with the device failing to connect tissue with a stapling device due to the staples not forming correctly.	IMDRF:A050704
C54451	CDRH Medical Device Problem Code Terminology	C187253	Failure to Seal	Problem associated with the device failing to seal the intended vessel with the device intended to provide a seal (e.g. electrosurgical hemostasis).	Failure to Seal	4070	Problem associated with the device failing to seal the intended vessel with the device intended to provide a seal (e.g. electrosurgical hemostasis).	IMDRF:A050705
C54451	CDRH Medical Device Problem Code Terminology	C99179	Audible Device Noise	An unintended or unpleasant sound that emanates from a device.	Noise, Audible	3273	Problem associated with any unintended sound which emanates from the device (for example, squeaking from two parts rubbing together or buzzing sounds from electrical components).	IMDRF:A0508
C54451	CDRH Medical Device Problem Code Terminology	C133513	Physical Resistance/Sticking	Problem associated with the lack of movement in the device due parts sticking or seizing.	Physical Resistance/Sticking	4012	Problem associated with the lack of movement in the device due parts sticking or seizing.	IMDRF:A0509
C54451	CDRH Medical Device Problem Code Terminology	C187254	Adhesive Too Strong	Strength of an adhesive bond is too great; typically used when the adhesive is meant as a temporary hold but is acting in a more permanent manner.	Adhesive Too Strong	4071	Strength of an adhesive bond is too great; typically used when the adhesive is meant as a temporary hold but is acting in a more permanent manner.	IMDRF:A050901
C54451	CDRH Medical Device Problem Code Terminology	C62929	Retraction Problem	Problem associated with drawing back the device to an intended location.	Retraction Problem	1536	Problem associated with drawing back the device to an intended location.	IMDRF:A0510
C54451	CDRH Medical Device Problem Code Terminology	C62923	Structural Problem	Problem associated with the basic physical construction or physical make up of the device.	Structural Problem	2506	Problem associated with the basic physical construction or physical make up of the device.	IMDRF:A0511
C54451	CDRH Medical Device Problem Code Terminology	C63272	Collapse of Device	Problem associated with the buckling or crushing of material from external forces.	Collapse	1099	Problem associated with the buckling or crushing of material from external forces.	IMDRF:A051101
C54451	CDRH Medical Device Problem Code Terminology	C133514	Sharp Edges	The device has undesirable sharp edges which can cause harm or damage.	Sharp Edges	4013	The device has undesirable sharp edges which can cause harm or damage.	IMDRF:A051102
C54451	CDRH Medical Device Problem Code Terminology	C63234	Difficult to Fold or Unfold	Problem associated with the use of the device in terms of the user experiencing difficulty to close or to spread out/extend length of the device, even if the operation is being performed according to labeled instructions for use.	Difficult to Fold, Unfold or Collapse	1254	Problem associated with the use of the device in terms of user experiencing difficulty to close or to spread out/extend length of the device, even if the operation is being performed according to labeled instructions for use.	IMDRF:A051103
C54451	CDRH Medical Device Problem Code Terminology	C63012	Difficult to Open or Close	Problem associated with the use of the device in terms of user experiencing difficulty opening and closing the device, even if the operation is being performed according to labeled instructions for use.	Difficult to Open or Close	2921	Problem associated with the use of the device in terms of user experiencing difficulty opening and closing the device, even if the operation is being performed according to labeled instructions for use.	IMDRF:A051104
C54451	CDRH Medical Device Problem Code Terminology	C63090	Incomplete Coaptation	Problem associated with the heart valve leaflet not closing properly.	Incomplete Coaptation	2507	Problem associated with the heart valve leaflet not closing properly.	IMDRF:A051105
C54451	CDRH Medical Device Problem Code Terminology	C62814	Unintended Movement	Movement of the device to an unintended location within the body.	Unintended Movement	3026	Problem associated with an undesired movement of the device, which may be related to the device malfunction, misdiagnosis, or mistreatment.	IMDRF:A0512
C54451	CDRH Medical Device Problem Code Terminology	C62950	Device Dislodged or Dislocated	Problems associated with the device not remaining in an expected location.	Device Dislodged or Dislocated	2923	Problems associated with the device not remaining in an expected location.	IMDRF:A051201
C54451	CDRH Medical Device Problem Code Terminology	C62921	Device Tipped Over	Problem associated with the inability of the device to stay in an upright position.	Device Tipped Over	2589	Problem associated with the inability of the device to stay in an upright position.	IMDRF:A051202
C54451	CDRH Medical Device Problem Code Terminology	C133516	Device Fell	Problem associated with the device or a component unexpectedly being dropped or moving down from an intended place.	Device Fell	4014	Problem associated with the device or a component unexpectedly being dropped or moving down from an intended place.	IMDRF:A051203
C54451	CDRH Medical Device Problem Code Terminology	C62840	Device Slipped	Problem associated with the device moving or sliding from the intended position.	Device Slipped	1584	Problem associated with the device moving or sliding from the intended position.	IMDRF:A051204
C54451	CDRH Medical Device Problem Code Terminology	C62819	Unintended Collision	Problem associated with the device impacting with another object.	Unintended Collision	1429	Problem associated with the device impacting with another object.	IMDRF:A051205
C54451	CDRH Medical Device Problem Code Terminology	C62813	Unintended System Motion	Problem associated with any motion of the system or components that was not initiated by the user.	Unintended System Motion	1430	Problem associated with any motion of the system or components that was not initiated by the user.	IMDRF:A051206
C54451	CDRH Medical Device Problem Code Terminology	C62809	Unstable Device	Problem associated with the mechanical stability of a device.	Unstable	1667	Problem associated with the mechanical stability of the device.	IMDRF:A051207
C54451	CDRH Medical Device Problem Code Terminology	C62806	Device Vibration	Problem associated with the undesirable mechanical oscillation in a device.	Vibration	1674	Problem associated with the undesirable mechanical oscillation.	IMDRF:A051208
C54451	CDRH Medical Device Problem Code Terminology	C171993	Inadequate Device Lubrication	Insufficient lubrication on a device.	Inadequate Lubrication	4057	The device shows inadequate lubrication.	IMDRF:A0513
C54451	CDRH Medical Device Problem Code Terminology	C62953	Optical Problem	Problem associated with transmission of visible light affecting the quality of the image transmitted or otherwise affecting the intended application of the visible light path.	Optical Problem	3001	Problem associated with transmission of visible light affecting the quality of the image transmitted or otherwise affecting the intended application of the visible light path.	IMDRF:A06
C54451	CDRH Medical Device Problem Code Terminology	C62913	Misfocusing	The problem relates to the poor focusing of the object or the focus is on the wrong object or in the wrong area.	Misfocusing	1401	The problem relates to the poor focusing of the object or the focus is on the wrong object or in the wrong area.	IMDRF:A0601
C54451	CDRH Medical Device Problem Code Terminology	C62891	Optical Decentration	Problem associated with being off-center of optical lenses.	Optical Decentration	1360	Problem associated with being off-center of optical lenses.	IMDRF:A0602
C54451	CDRH Medical Device Problem Code Terminology	C62890	Optical Discoloration	Problem associated with an undesired change of color.	Optical Discoloration	2999	Problem associated with an undesired change of color.	IMDRF:A0603
C54451	CDRH Medical Device Problem Code Terminology	C62889	Optical Distortion	Problem associated with an optical defect in an image-forming system whereby the image is not the shape of an ideal image of the object.	Optical Distortion	3000	Problem associated with an optical defect in an image-forming system whereby the image is not the shape of an ideal image of the object.	IMDRF:A0604
C54451	CDRH Medical Device Problem Code Terminology	C62888	Optical Obstruction	Problem associated with the blocking of optical devices, e.g. visual pathways.	Optical Obstruction	3002	Problem associated with the blocking of optical devices, e.g. visual pathways.	IMDRF:A0605
C54451	CDRH Medical Device Problem Code Terminology	C63007	Electrical/Electronic Property Problem	Problem associated with a failure of the electrical circuitry of the device.	Electrical /Electronic Property Problem	1198	Problem associated with a failure of the electrical circuitry of the device.	IMDRF:A07
C54451	CDRH Medical Device Problem Code Terminology	C63027	Capturing Problem	Problem associated with the inability of the device to achieve successful depolarization and contraction of a cardiac chamber caused by a pacemaker output pulse.	Capturing Problem	2891	Problem associated with the inability of the device to achieve successful depolarization and contraction of a cardiac chamber caused by a pacemaker output pulse.	IMDRF:A0701
C54451	CDRH Medical Device Problem Code Terminology	C62993	Failure to Capture	Problem associated with the failure to achieve effective and consistent depolarization of the heart resulting from the electrical stimulus of the pacemaker.	Failure to Capture	1081	Problem associated with the failure to achieve effective and consistent depolarization of the heart resulting from the electrical stimulus of the pacemaker.	IMDRF:A070101
C54451	CDRH Medical Device Problem Code Terminology	C95875	High Capture Threshold	Problem with the amount of output energy needed to cause cardiac depolarization being higher than expected/desired.	High Capture Threshold	3266	Problem with the amount of output energy needed to cause cardiac depolarization being higher than expected/desired.	IMDRF:A070102
C54451	CDRH Medical Device Problem Code Terminology	C63069	Intermittent Capture	Problem associated with the ineffective and inconsistent depolarization of the heart.	Intermittent Capture	1080	Problem associated with the ineffective and inconsistent depolarization of the heart.	IMDRF:A070103
C54451	CDRH Medical Device Problem Code Terminology	C95876	Unstable Capture Threshold	Problem with the amount of output energy needed to cause cardiac depolarization being unstable.	Unstable Capture Threshold	3269	Problem with the amount of output energy needed to cause cardiac depolarization being unstable.	IMDRF:A070104
C54451	CDRH Medical Device Problem Code Terminology	C63265	Continuous Firing	Problem associated with the excessive production of electrical impulses over a period.	Continuous Firing	1123	Problem associated with the excessive production of electrical impulses over a period.	IMDRF:A0702
C54451	CDRH Medical Device Problem Code Terminology	C63301	Electrical Arcing	Problem associated with electrical current flowing through a gap between two conductive surfaces, typically resulting in a visible flash of light.	Arcing	2583	Problem associated with electrical current flowing through a gap between two conductive surfaces, typically resulting in a visible flash of light.	IMDRF:A0703
C54451	CDRH Medical Device Problem Code Terminology	C63302	Electrical Arcing at Paddles	Problem associated with electrical current flowing through a gap between paddles (conductive surfaces), typically resulting in a visible flash of light.	Arcing at Paddles	1032	Problem associated with electrical current flowing through a gap between paddles (conductive surfaces), typically resulting in a visible flash of light.	IMDRF:A070301
C54451	CDRH Medical Device Problem Code Terminology	C63303	Electrical Arcing at Electrodes	Problem associated with electrical current flowing through a gap between electrodes (conductive surfaces), typically resulting in a visible flash of light.	Arcing of Electrodes	2289	Problem associated with electrical current flowing through a gap between electrodes (conductive surfaces), typically resulting in a visible flash of light.	IMDRF:A070302
C54451	CDRH Medical Device Problem Code Terminology	C62837	Sparking	Problem associated with a flash of light related to an electrical discharge into a normally non conductive medium, such as air. Not associated with a discharge between two conductive surfaces.	Sparking	2595	Problem associated with a flash of light related to an electrical discharge into a normally non conductive medium, such as air. Not associated with a discharge between two conductive surfaces.	IMDRF:A0704
C54451	CDRH Medical Device Problem Code Terminology	C63030	Battery Problem	Problem associated with the internal power of a device (e.g. battery, transformer, fuel cell or other power sources).	Battery Problem	2885	Problem associated with the internal power of the device (e.g. battery, transformer, fuel cell or other power sources).	IMDRF:A0705
C54451	CDRH Medical Device Problem Code Terminology	C64336	Battery Problem: High Impedence	Problem related to increased battery internal impedance.	Battery Problem: High Impedance	2947	Problem related to increased battery internal impedance.	IMDRF:A070501
C54451	CDRH Medical Device Problem Code Terminology	C64335	Battery Problem: Low Impedence	Problem related to decreased battery internal impedance.	Battery Problem: Low Impedance	2973	Problem related to decreased battery internal impedance.	IMDRF:A070502
C54451	CDRH Medical Device Problem Code Terminology	C62990	Failure to Run on Battery	Problem associated with the device failing to operate when not connected to a fixed power source.	Failure to Run on Battery	1466	Problem associated with the device failing to operate when not connected to a fixed power source.	IMDRF:A070503
C54451	CDRH Medical Device Problem Code Terminology	C62864	Premature Discharge of Battery	Battery discharging earlier than expected.	Premature Discharge of Battery	1057	Battery discharging earlier than expected.	IMDRF:A070504
C54451	CDRH Medical Device Problem Code Terminology	C63026	Charging Problem	Problem associated with the inability of a device to successfully charge an electrical source.	Charging Problem	2892	Problem associated with the inability of the device to successfully charge an electrical source.	IMDRF:A0706
C54451	CDRH Medical Device Problem Code Terminology	C63281	Charge Aborted	Problem associated with the premature ending of the charging process (e.g. of a battery or other charge storage device).	Aborted Charge	2288	Problem associated with the premature ending of the charging process (e.g. of a battery or other charge storage device).	IMDRF:A070601
C54451	CDRH Medical Device Problem Code Terminology	C63280	Delayed Charge Time	Problem associated with an unexpected amount of time required to charge the device (e.g. a delay in starting charging or a longer than expected charge time).	Delayed Charge Time	2586	Problem associated with an unexpected amount of time required to charge the device (e.g. a delay in starting charging or a longer than expected charge time).	IMDRF:A070602
C54451	CDRH Medical Device Problem Code Terminology	C63193	Failure to Charge	Problem associated with inability to initiate the appropriate charging process (e.g. of a battery or other charge storage device).	Failure to Charge	1085	Problem associated with inability to initiate the appropriate charging process (e.g. of a battery or other charge storage device)	IMDRF:A070603
C54451	CDRH Medical Device Problem Code Terminology	C63181	Failure to Discharge	Problem associated with the failure of a battery or other charge storage device to appropriately discharge as intended. Does not apply to defibrillation.	Failure to Discharge	1169	Problem associated with the failure of a battery or other charge storage device to appropriately discharge as intended. Does not apply to defibrillation.	IMDRF:A0707
C54451	CDRH Medical Device Problem Code Terminology	C63025	Power Problem	Problem associated with the energy to operate the device.	Power Problem	3010	Problem associated with the energy to operate the device.	IMDRF:A0708
C54451	CDRH Medical Device Problem Code Terminology	C133517	Device Complete Loss of Power	Problem associated with the lack of power to run a device.	Complete Loss of Power	4015	Problem associated with the lack of power to run the device.	IMDRF:A070801
C54451	CDRH Medical Device Problem Code Terminology	C133520	Intermittent Loss of Power	Problem associated with an intermittent disruption to the power to run the device.	Intermittent Loss of Power	4016	Problem associated with an intermittent disruption to the power to run the device.	IMDRF:A070802
C54451	CDRH Medical Device Problem Code Terminology	C62992	Failure to Power-Up	Problem associated with the inability of the device to turn on related to energy delivered to a medical device.	Failure to Power Up	1476	Problem associated with the inability of the device to turn on related to energy delivered to the device.	IMDRF:A070803
C54451	CDRH Medical Device Problem Code Terminology	C62818	Unintended Power Up	Problem associated with the device turning on when not intended.	Unintended Power Up	1162	Problem associated with the device turning on when not intended.	IMDRF:A070804
C54451	CDRH Medical Device Problem Code Terminology	C63238	Device Sensing Issue	Problem associated with the device feature that are designed to respond to a physical stimulus (temperature, illumination, motion, cardiac rhythms) and that do not transmit a resulting signal for interpretation or measurement.	Device Sensing Problem	2917	Problem associated with the device feature that are designed to respond to a physical stimulus (temperature, illumination, motion, cardiac rhythms) and that do not transmit a resulting signal for interpretation or measurement.	IMDRF:A0709
C54451	CDRH Medical Device Problem Code Terminology	C63253	Decreased Device Sensitivity	Problem with a medical device being less sensitive to an input than intended or expected.	Decreased Sensitivity	2534	Problem with the device being less sensitive to an input than intended or expected.	IMDRF:A070901
C54451	CDRH Medical Device Problem Code Terminology	C63078	Increased Device Sensitivity	Problem with a medical device being more sensitive to an input than intended or expected.	Increased Sensitivity	2535	Problem with the device being more sensitive to an input than intended or expected.	IMDRF:A070902
C54451	CDRH Medical Device Problem Code Terminology	C63196	Failure to Analyze Signal	Problem with the device not analyzing a signal.	Failure to Analyze Signal	1539	Problem with the device not analyzing a signal.	IMDRF:A070903
C54451	CDRH Medical Device Problem Code Terminology	C63161	Failure to Select Signal	Problem associated with the failure of the device to select the appropriate input signal.	Failure to Select Signal	1582	Problem associated with the failure of the device to select the appropriate input signal.	IMDRF:A070904
C54451	CDRH Medical Device Problem Code Terminology	C63121	High Sensing	Problem associated with the amount of input required by the device to detect a signal being higher than expected/desired.	High Sensing Threshold	2574	Problem associated with the amount of input required by the device to detect a signal being higher than expected/desired.	IMDRF:A070905
C54451	CDRH Medical Device Problem Code Terminology	C63044	Low Sensing Threshold	Problem associated with the amount of an input required by the device to detect a signal being lower than expected/desired.	Low Sensing Threshold	2575	Problem associated with the amount of an input required by the device to detect a signal being lower than expected/desired.	IMDRF:A070906
C54451	CDRH Medical Device Problem Code Terminology	C63050	Loss of Threshold	Problem associated with the loss of the minimum amount of energy, voltage, or current needed to consistently stimulate the heart muscle.	Loss of Threshold	1633	Problem associated with the loss of the minimum amount of energy, voltage, or current needed to consistently stimulate the heart muscle.	IMDRF:A070907
C54451	CDRH Medical Device Problem Code Terminology	C63160	Failure to Sense	Problem associated with the failure of the device designed to respond to a physical stimulus (as temperature, illumination, motion) to transmit a resulting signal for interpretation or measurement.	Failure to Sense	1559	Problem associated with the failure of the device designed to respond to a physical stimulus (as temperature, illumination, motion) to transmit a resulting signal for interpretation or measurement.	IMDRF:A070908
C54451	CDRH Medical Device Problem Code Terminology	C62881	Oversensing	Problem related to failure of the device to properly filter cardiac signals resulting in inappropriate device response.	Over-Sensing	1438	Problem related to failure of the device to properly filter cardiac signals resulting in inappropriate device response.	IMDRF:A070909
C54451	CDRH Medical Device Problem Code Terminology	C62822	Undersensing	Problem related to failure of the device to properly detect intrinsic cardiac activity and respond appropriately.	Under-Sensing	1661	Problem related to failure of the device to properly detect intrinsic cardiac activity and respond appropriately.	IMDRF:A070910
C54451	CDRH Medical Device Problem Code Terminology	C63065	Sensing Intermittently	Problem with the device receiving an incoming signal on an intermittent basis when expected to be continuous.	Sensing Intermittently	1558	Problem with the device receiving an incoming signal on an intermittent basis when expected to be continuous.	IMDRF:A070911
C54451	CDRH Medical Device Problem Code Terminology	C63086	Incorrect Interpretation of Signal	Problem with the device inappropriately analyzing a signal.	Incorrect Interpretation of Signal	1543	Problem with the device inappropriately analyzing a signal.	IMDRF:A070912
C54451	CDRH Medical Device Problem Code Terminology	C63191	Failure to Conduct	Problem associated with the inability of the device to allow a current of electricity to pass or to conduct electricity continuously along an electrical path.	Failure to Conduct	1114	Problem associated with the inability of the device to allow a current of electricity to pass or to conduct electricity continuously along an electrical path.	IMDRF:A0710
C54451	CDRH Medical Device Problem Code Terminology	C133523	Interrogation Problem	Problems associated with the device's ability to respond to signals from a system designed to interrogate its status.	Interrogation Problem	4017	Problems associated with the device's ability to respond to signals from a system designed to interrogate its status.	IMDRF:A0711
C54451	CDRH Medical Device Problem Code Terminology	C63232	Difficult to Interrogate	Problem associated with difficulty of a transponder system to trigger a response.	Difficult to Interrogate	1331	Problem associated with difficulty of a transponder system to trigger a response.	IMDRF:A071101
C54451	CDRH Medical Device Problem Code Terminology	C63173	Failure to Interrogate	Problem associated with the device failure to appropriately respond to signals from a system designed to interrogate its status.	Failure to Interrogate	1332	Problem associated with the device failure to appropriately respond to signals from a system designed to interrogate its status.	IMDRF:A071102
C54451	CDRH Medical Device Problem Code Terminology	C63169	Pacing Problem	Problem associated with the inability of the device to generate a therapeutic simulated heart beat via electrical impulses.	Pacing Problem	1439	Problem associated with the inability of the device to generate a therapeutic simulated heart beat via electrical impulses.	IMDRF:A0712
C54451	CDRH Medical Device Problem Code Terminology	C63190	Failure to Convert Rhythm	Failure of the device therapy or set of therapies to terminate the harmful cardiac rhythm that the therapy is meant to terminate.	Failure to Convert Rhythm	1540	Failure of the device therapy or set of therapies to terminate the harmful cardiac rhythm that the therapy is meant to terminate.	IMDRF:A071201
C54451	CDRH Medical Device Problem Code Terminology	C63101	Inaccurate Synchronization	Problem associated with an error due to imperfect timing of two operations, e.g. signal transmission time.	Inaccurate Synchronization	1609	Problem associated with an error due to imperfect timing of two operations, e.g. signal transmission time.	IMDRF:A071202
C54451	CDRH Medical Device Problem Code Terminology	C63157	Inappropriate Waveform	Failure of the device to generate a correctly-shaped pacing output, e.g., a waveform that is too wide.	Inappropriate Waveform	2536	Failure of the device to generate a correctly-shaped pacing output, e.g., a waveform that is too wide.	IMDRF:A071203
C54451	CDRH Medical Device Problem Code Terminology	C95877	No Pacing	Problem associated with the device ceasing to deliver paces.	No Pacing	3268	Problem associated with the device ceasing to deliver paces.	IMDRF:A071204
C54451	CDRH Medical Device Problem Code Terminology	C62880	Pacer Found in Back-Up Mode	A device with a pacing function found in back-up mode. This may be an appropriate fail-safe action (e.g. end of battery life), or be caused by device-malfunction or due to operator error.	Pacemaker Found in Back-Up Mode	1440	A device with a pacing function found in back-up Mode. This may be an appropriate fail-safe action (e.g. end of battery life), or be caused by device malfunction or due to operator error.	IMDRF:A071205
C54451	CDRH Medical Device Problem Code Terminology	C63298	Pacing Asynchronously	Problem associated with a pacing transmission process such that between any two significant instants in the same group, there is always an integral number of unit intervals. Between two significant instants located in different groups, there are not always an integral number of unit intervals.	Pacing Asynchronously	1441	Problem associated with a pacing transmission process such that between any two significant instants in the same group, there is always an integral number of unit intervals. Between two significant instants located in different groups, there are not always an integral number of unit intervals.	IMDRF:A071206
C54451	CDRH Medical Device Problem Code Terminology	C63097	Pacing Inadequately	Pacing voltage or pulse width is less than desired.	Pacing Inadequately	1442	Pacing voltage or pulse width is less than desired.	IMDRF:A071207
C54451	CDRH Medical Device Problem Code Terminology	C63066	Pacing Intermittently	Problem associated with the failure of pacing device for a limited period of time, following which the item recovers its ability to perform its required function without being subjected to any external corrective action. Note: such as failure is often recurrent.	Pacing Intermittently	1443	Problem associated with the failure of pacing device for a limited period of time, following which the item recovers its ability to perform its required function without being subjected to any external corrective action. Note: such as failure is often recurrent.	IMDRF:A071208
C54451	CDRH Medical Device Problem Code Terminology	C62872	Pocket Stimulation	Problem associated with a pocket of skin in which the pulse generator is housed.	Pocket Stimulation	1463	Problem associated with a pocket of skin in which the pulse generator is housed.	IMDRF:A071209
C54451	CDRH Medical Device Problem Code Terminology	C63158	Defibrillation Problem	Problem associated with the inability of the device to provide an appropriate or successful electrical shock.	Defibrillation/Stimulation Problem	1573	Problem associated with the delivery of electrical shock/stimulation by a device intended to deliver shocks/stimulation.	IMDRF:A0713
C54451	CDRH Medical Device Problem Code Terminology	C63185	Failure to Deliver Shock	Problem associated with the failure of the device to deliver electrical energy intended to change an electrical rhythm.	Failure to Deliver Shock/Stimulation	1133	Problem associated with the failure of the device to deliver electrical energy.	IMDRF:A071301
C54451	CDRH Medical Device Problem Code Terminology	C63093	Inappropriate Shock	Problem associated with the inappropriate delivery of an electrical energy.	Inappropriate/Inadequate Shock/Stimulation	1574	A shock was delivered with incorrect energy level or at incorrect timing.	IMDRF:A071302
C54451	CDRH Medical Device Problem Code Terminology	C63064	Intermittent Shock	Problem associated with the failure to deliver shock for a limited period of time, following which the item recovers its ability to perform its required function without being subjected to any external corrective action. Note: such as failure is often recurrent.	Intermittent Shock/Stimulation	2287	Problem associated with the failure to deliver electrical energy for a limited period of time, following which the item recovers its ability to perform its required function without being subjected to any external corrective action. Note: such a failure is often recurrent.	IMDRF:A071303
C54451	CDRH Medical Device Problem Code Terminology	C133527	Unintended Electrical Shock	The device delivers unintended electrical shock.	Unintended Electrical Shock	4018	The device delivers unintended electrical shock. Use this term for devices that are not intended to deliver shocks/stimulation.	IMDRF:A0714
C54451	CDRH Medical Device Problem Code Terminology	C63125	Grounding Malfunction	Problem associated with the inability to connect conductors of an electronic system for the purpose of controlling or impeding ground currents and voltages.	Grounding Malfunction	1271	Problem associated with the inability to connect conductors of an electronic system for the purpose of controlling or impeding ground currents and voltages.	IMDRF:A0715
C54451	CDRH Medical Device Problem Code Terminology	C63218	Electrical Overstress	Problem associated with electrical activity of the device that exceeded the specified threshold limit of the internal integrated circuitry.	Electrical Overstress	2924	Problem associated with an electrical activity that exceeded the specified threshold limit of the internal integrated circuitry.	IMDRF:A0716
C54451	CDRH Medical Device Problem Code Terminology	C63213	Electro-Static Discharge Problem	Problem associated with the discharge of electricity between two bodies previously electrically charged.	Electro-Static Discharge	2149	Problem associated with the discharge of electricity between two bodies previously electrically charged.	IMDRF:A0717
C54451	CDRH Medical Device Problem Code Terminology	C62988	Failure to Shut Off	Problem associated with the device not powering off when a shut down was requested.	Failure to Shut Off	2939	Problem associated with the device not powering off when a shut down was requested.	IMDRF:A0718
C54451	CDRH Medical Device Problem Code Terminology	C62931	Device Remains Activated	Problem associated with the device continuing to be in an active state after deactivation was requested.	Device Remains Activated	1525	Problem associated with the device continuing to be in an active state after deactivation was requested.	IMDRF:A071801
C54451	CDRH Medical Device Problem Code Terminology	C133544	Unexpected Shutdown	Problem associated with the device unexpectedly powering down.	Unexpected Shutdown	4019	Problem associated with the device unexpectedly powering down.	IMDRF:A0719
C54451	CDRH Medical Device Problem Code Terminology	C63215	Electromagnetic Compatibility Problem	Problem associated with the ability of a system to function in its electromagnetic environment without introducing intolerable disturbances to anything in its environment.	Electromagnetic Compatibility Problem	2927	Problem associated with the ability of a system to function in its electromagnetic environment without introducing intolerable disturbances to anything in its environment.	IMDRF:A0720
C54451	CDRH Medical Device Problem Code Terminology	C63214	Electromagnetic Interference	Problem associated with a measure of electromagnetic radiation from equipment.	Electromagnetic Interference	1194	Problem associated with a measure of electromagnetic radiation from equipment.	IMDRF:A072001
C54451	CDRH Medical Device Problem Code Terminology	C62855	Radiofrequency Interference Problem	Problem associated with the degradation of the reception of a wanted signal caused by RF disturbance.	Radiofrequency Interference (RFI)	2314	Problem associated with the degradation of the reception of a wanted signal caused by RF disturbance.	IMDRF:A072002
C54451	CDRH Medical Device Problem Code Terminology	C63277	Circuit Failure	Problem associated with a failure of the internal network paths or electrical circuitry (i.e. electrical components, circuit boards, wiring).	Circuit Failure	1089	Problem associated with a failure of the internal network paths or electrical circuitry (i.e. electrical components, circuit boards, wiring)	IMDRF:A0721
C54451	CDRH Medical Device Problem Code Terminology	C63283	Capacitative Coupling	Problem associated with the transfer of energy within an electrical network by means of the capacitance between circuit nodes. It occurs when energy is coupled from one circuit to another through an electric field.	Capacitative Coupling	1079	Problem associated with the transfer of energy within an electrical network by means of the capacitance between circuit nodes. It occurs when energy is coupled from one circuit to another through an electric field.	IMDRF:A072101
C54451	CDRH Medical Device Problem Code Terminology	C63216	Electrical Shorting	Problem associated with an electric current travelling along an accidental path (unintended path) in a circuit.	Electrical Shorting	2926	Problem associated with an electric current travelling along an accidental path (unintended path) in a circuit.	IMDRF:A072102
C54451	CDRH Medical Device Problem Code Terminology	C63068	Intermittent Continuity	Problem associated with intermittent faults in electrical/electronic interconnections.	Intermittent Continuity	1121	Problem associated with intermittent faults in electrical/electronic interconnections.	IMDRF:A072103
C54451	CDRH Medical Device Problem Code Terminology	C63114	Impedance Problem	Problem associated with electrical impedance levels between device and patient connections.	Impedance Problem	2950	Problem associated with electrical impedance levels between device and patient connections.	IMDRF:A0722
C54451	CDRH Medical Device Problem Code Terminology	C63124	High Impedance	Problem associated with higher than intended electrical impedance levels between device and patient connections.	High impedance	1291	Problem associated with higher than intended electrical impedance levels between device and patient connections.	IMDRF:A072201
C54451	CDRH Medical Device Problem Code Terminology	C63047	Low Impedance	Problem associated with lower than intended electrical impedance levels between device and patient connections.	Low impedance	2285	Problem associated with lower than intended electrical impedance levels between device and patient connections.	IMDRF:A072202
C54451	CDRH Medical Device Problem Code Terminology	C63028	Calibration Problem	Problem associated with the operation of a device, related to its accuracy, and associated with the calibration of the device.	Calibration Problem	2890	Problem associated with the operation of the device, related to its accuracy, and associated with the calibration of the device.	IMDRF:A08
C54451	CDRH Medical Device Problem Code Terminology	C62994	Failure to Calibrate Problem	Problem associated with the failure of the device to perform a self-calibration procedure or process designed to assure the accuracy and proper performance of the device.	Failure to Calibrate	2440	Problem associated with the failure of the device to perform a self-calibration procedure or process designed to assure the accuracy and proper performance of the device.	IMDRF:A0801
C54451	CDRH Medical Device Problem Code Terminology	C63241	Failure to Recalibrate	Problem associated with the failure of the device which is unable to regain a standard level of accuracy when performing a calibration procedure or process designed to assure the accuracy and proper performance of the device.	Failure to Recalibrate	1517	Problem associated with the failure of the device which is unable to regain a standard level of accuracy when performing a calibration procedure or process designed to assure the accuracy and proper performance of the device.	IMDRF:A0802
C54451	CDRH Medical Device Problem Code Terminology	C63113	Device Imprecision	Problem associated with the device providing imprecise measurements when compared to a reference standard.	Imprecision	1307	Problem associated with the device providing imprecise measurements when compared to a reference standard.	IMDRF:A0803
C54451	CDRH Medical Device Problem Code Terminology	C72890	Overcorrection	Problem associated with an adjustment that surpasses a set of criteria.	Overcorrection	3006	Problem associated with an adjustment that surpasses a set of criteria.	IMDRF:A0804
C54451	CDRH Medical Device Problem Code Terminology	C172043	Undercorrection	Problem associated with an adjustment that falls below a set of criteria.	Undercorrection	4058	Problem associated with an adjustment that falls below a set of criteria.	IMDRF:A0805
C54451	CDRH Medical Device Problem Code Terminology	C62941	Output Problem	Problem associated with any deviation from the documented specifications of the device that relate to the end result, data, or test results provided by the device.	Output Problem	3005	Problem associated with any deviation from the documented specifications of the device that relate to the end result, data, or test results provided by the device.	IMDRF:A09
C54451	CDRH Medical Device Problem Code Terminology	C133545	Audible Prompt/Feedback	Problem with any deviation from the documented specifications of a device that relates to audible feedback.	Audible Prompt/Feedback Problem	4020	Problem with any deviation from the documented specifications of the device that relate to audible feedback. e.g. voice prompts or beeps, but not safety related alarms which are covered under "Protective Measures Problem".	IMDRF:A0901
C54451	CDRH Medical Device Problem Code Terminology	C63094	Inappropriate Audible Prompt/Feedback	Problem with audible messages which do not guide a device user to the correct action.	Inappropriate Audible Prompt/Feedback	2280	Problem with audible messages which do not guide a device user to the correct action.	IMDRF:A090101
C54451	CDRH Medical Device Problem Code Terminology	C63092	Inaudible or Unclear Audible Prompt/Feedback	Problem associated with audible prompts which cannot be heard clearly.	Inaudible or Unclear Audible Prompt/Feedback	2283	Problem associated with audible prompts which cannot be heard clearly.	IMDRF:A090102
C54451	CDRH Medical Device Problem Code Terminology	C62899	No Audible Prompt/Feedback	Problem associated with the device ceasing to provide audible prompts.	No Audible Prompt/Feedback	2282	Problem associated with the device ceasing to provide audible prompts.	IMDRF:A090103
C54451	CDRH Medical Device Problem Code Terminology	C63088	Display or Visual Feedback Problem	Problem with any deviation from the documented specifications of the device that relate to visual feedback. e.g. the display of information, images on a screen, or output from the device.	Display or Visual Feedback Problem	1184	Problem with any deviation from the documented specifications of the device that relate to visual feedback. e.g. the display of information, images on a screen, or output from the device.	IMDRF:A0902
C54451	CDRH Medical Device Problem Code Terminology	C63205	Device Displays Incorrect Message	Problem associated with providing incorrect display information.	Device Displays Incorrect Message	2591	Problem associated with providing incorrect display information.	IMDRF:A090201
C54451	CDRH Medical Device Problem Code Terminology	C63221	Display Difficult to Read	Problem associated with legibility of the device display, compromising for instance, the reading/interpretation of patient parameters or test results. Legibility problems can be due to color, size of font, display screen contrast or other factors.	Display Difficult to Read	1181	Problem associated with legibility of the display, compromising for instance  the reading/interpretation of patient parameters or test results. Legibility problems can be due to color, size of font, display screen contrast or other factors.	IMDRF:A090202
C54451	CDRH Medical Device Problem Code Terminology	C63207	Erratic or Intermittent Display	A device that does not consistently display the same message, result, reading, or image. e.g. the display might flicker, switch between readings or messages, or go completely blank for brief periods of time.	Erratic or Intermittent Display	1182	A device does not consistently display the same message, result, reading, or image. e.g. the display might flicker, switch between readings or messages, or go completely blank for brief periods of time.	IMDRF:A090203
C54451	CDRH Medical Device Problem Code Terminology	C63117	Image Display Error/Artifact	Problem with image display leading to corrupted images or readouts/measurement indications.	Image Display Error/Artifact	1304	Problem with image display leading to corrupted images or readouts/measurement indications.	IMDRF:A090204
C54451	CDRH Medical Device Problem Code Terminology	C62887	Image Orientation Incorrect	Problem associated with an incorrect image orientation on the device display.	Image Orientation Incorrect	1305	Problem associated with an incorrect image orientation on the device display.	IMDRF:A090205
C54451	CDRH Medical Device Problem Code Terminology	C62904	No Display/Image	Problem associated with the absence of display or image.	No Display/Image	1183	Problem associated with the absence of display or image.	IMDRF:A090206
C54451	CDRH Medical Device Problem Code Terminology	C133546	No Visual Prompts/Feedback	Problem associated with the device ceasing to provide visual feedback.	No Visual Prompts/Feedback	4021	Problem associated with the device ceasing to provide visual feedback.	IMDRF:A090207
C54451	CDRH Medical Device Problem Code Terminology	C62869	Poor Quality Image	Inadequate quality of an image or any visual representation displayed by the device, or output from the device.	Poor Quality Image	1408	Inadequate quality of an image or any visual representation displayed by the device, or output from the device.	IMDRF:A090208
C54451	CDRH Medical Device Problem Code Terminology	C62861	Visual Prompts will not Clear	Problem with visual messages which continue to be displayed on/by the device after the appropriate action has been taken.	Visual Prompts will not Clear	2281	Problem with visual messages which continue to be displayed on/by the device after the appropriate action has been taken.	IMDRF:A090209
C54451	CDRH Medical Device Problem Code Terminology	C133547	Tactile Prompts/Feedback	Problem with any deviation from the documented specifications of the device that relates to tactile feedback, e.g. device vibrational prompt.	Tactile Prompts/Feedback	4022	Problem with any deviation from the documented specifications of the device that relate to tactile feedback. e.g device vibrational prompt.	IMDRF:A0903
C54451	CDRH Medical Device Problem Code Terminology	C133551	Inappropriate Tactile Prompt/Feedback	Problem with tactile feedback which does not guide a device user to the correct action.	Inappropriate Tactile Prompt/Feedback	4023	Problem with tactile feedback which does not guide a device user to the correct action.	IMDRF:A090301
C54451	CDRH Medical Device Problem Code Terminology	C133559	No Tactile Prompts/Feedback	Problem associated with the device ceasing to provide tactile feedback.	No Tactile Prompts/Feedback	4024	Problem associated with the device ceasing to provide tactile feedback.	IMDRF:A090302
C54451	CDRH Medical Device Problem Code Terminology	C63002	Energy Output Problem	Problem with the device's intended output of energy.	Energy Output Problem	1431	Problem with the device's intended output of energy.	IMDRF:A0904
C54451	CDRH Medical Device Problem Code Terminology	C63000	Energy Spectrum Incorrect	Problem associated with the energy output from the device not being in the expected part of the spectrum.	Energy Spectrum Incorrect	1210	Problem associated with the energy output from the device not being in the expected part of the spectrum.	IMDRF:A090401
C54451	CDRH Medical Device Problem Code Terminology	C63184	Failure to Deliver Energy	Problem associated with the failure of the device to deliver any energy.	Failure to Deliver Energy	1211	Problem associated with the failure of the device to deliver any energy.	IMDRF:A090402
C54451	CDRH Medical Device Problem Code Terminology	C133561	Intermittent Energy Output	Problem associated with the energy output from the device being inconsistent over time.	Intermittent Energy Output	4025	Problem associated with the energy output from the device being inconsistent over time.	IMDRF:A090403
C54451	CDRH Medical Device Problem Code Terminology	C62943	Output above Specifications	Device output is exceeding the documented specifications of the device.	Output above Specifications	1432	Device output is exceeding the documented specifications of the device.	IMDRF:A090404
C54451	CDRH Medical Device Problem Code Terminology	C62942	Output below Specifications	Device output is below the documented specifications of the device.	Output below Specifications	3004	Device output is below the documented specifications of the device.	IMDRF:A090405
C54451	CDRH Medical Device Problem Code Terminology	C62828	Therapeutic or Diagnostic Output Failure	Problem associated with the failure of the device to deliver the output required for treatment or identification of a disease.	Therapeutic or Diagnostic Output Failure	3023	Problem associated with the failure of the device to deliver the output required for treatment or identification of a disease.	IMDRF:A090406
C54451	CDRH Medical Device Problem Code Terminology	C62858	Therapy Delivered to Incorrect Body Area	Problem associated with the device causing unintended therapeutic action to an area of the body other than the intended area.	Therapy Delivered to Incorrect Body Area	1508	Problem associated with the device causing unintended therapeutic action to an area of the body other than the intended area.	IMDRF:A090407
C54451	CDRH Medical Device Problem Code Terminology	C133562	Radiation Output Problem	Problem with the device's intended output of radiation.	Radiation Output Problem	4026	Problem with the device's intended output of radiation.	IMDRF:A0905
C54451	CDRH Medical Device Problem Code Terminology	C133569	Radiation Output Failure	Problem associated with the absence of radiation output from radiological or diagnostic devices.	Radiation Output Failure	4027	Problem associated with the absence of radiation output from radiological or diagnostic devices.	IMDRF:A090501
C54451	CDRH Medical Device Problem Code Terminology	C72892	Radiation Overexposure	Problem associated with excessive radiation emitted from radiological or diagnostic devices.	Radiation Overexposure	3017	Problem associated with excessive radiation emitted from radiological or diagnostic devices.	IMDRF:A090502
C54451	CDRH Medical Device Problem Code Terminology	C72893	Radiation Underexposure	Problem associated with too little radiation emitted from radiological or diagnostic devices.	Radiation Underexposure	3018	Problem associated with too little radiation emitted from radiological or diagnostic devices.	IMDRF:A090503
C54451	CDRH Medical Device Problem Code Terminology	C133571	Unexpected/Unintended Radiation Output	Device-emitted radiation when it was not supposed to. This applies to devices which are intended to emit radiation, and the radiation being emitted from the correct part of the device, but at an incorrect time.	Unexpected/Unintended Radiation Output	4028	Device-emitted radiation when it was not supposed to. This applies to devices which are intended to emit radiation, and the radiation being emitted from the correct part of the device, but at an incorrect time. Use "radiation leak" if the device emits radiation which should never have been emitted, or from a location from which it should never be emitted.	IMDRF:A090504
C54451	CDRH Medical Device Problem Code Terminology	C63109	Gas Output Problem	Problem associated with gas output.	Gas Output Problem	1266	Problem associated with gas output.	IMDRF:A0906
C54451	CDRH Medical Device Problem Code Terminology	C62900	No Device Output	Problem associated with no measurement outcome, value or data obtained from the device.	No Device Output	1435	Problem associated with no measurement outcome, value or data obtained from the device.	IMDRF:A0907
C54451	CDRH Medical Device Problem Code Terminology	C62848	Incorrect, Inadequate or Imprecise Result or Readings	Problem associated with a nonconforming end result, data, or test results provided by the device to its performance specifications.	Incorrect, Inadequate or Imprecise Result or Readings	1535	Problem associated with a nonconforming end result, data, or test results provided by the device to its performance specifications.	IMDRF:A0908
C54451	CDRH Medical Device Problem Code Terminology	C63300	Signal Artifact	Problem associated with impurities or interference in a signal (e.g. ECG artifact).	Signal Artifact/Noise	1036	Problem associated with impurities or interference in a signal (e.g. ECG artifact).	IMDRF:A090801
C54451	CDRH Medical Device Problem Code Terminology	C63172	Failure to Obtain Sample	The device does not collect or transfer the sample as intended.	Failure to Obtain Sample	2533	The device does not collect or transfer the sample.	IMDRF:A090802
C54451	CDRH Medical Device Problem Code Terminology	C63149	False Negative Result	Problem associated with the device incorrectly reporting that something has not been detected and may mislead the operator into not taking certain actions when action should be taken.	False Negative Result	1225	Problem associated with the device incorrectly reporting that something has not been detected and may mislead the operator into not taking certain actions when action should be taken.	IMDRF:A090803
C54451	CDRH Medical Device Problem Code Terminology	C63147	False Positive Result	Problem associated with the device incorrectly reporting that something has been detected and may mislead the operator to take certain actions.	False Positive Result	1227	Problem associated with the device incorrectly reporting that something has been detected and may mislead the operator to take certain actions.	IMDRF:A090804
C54451	CDRH Medical Device Problem Code Terminology	C63085	Incorrect Measurement	Measurement obtained from or provided by the device is obviously incorrect.	Incorrect Measurement	1383	Measurement obtained from or provided by the device is obviously incorrect.	IMDRF:A090805
C54451	CDRH Medical Device Problem Code Terminology	C133574	Non-Reproducible Results	Device results that cannot be reliably reproduced.	Non Reproducible Results	4029	Device results cannot be reliably reproduced.	IMDRF:A090806
C54451	CDRH Medical Device Problem Code Terminology	C63123	High Readings	Reading provided by the device is too high or higher than expected.	High Readings	2459	Reading provided by the device is too high or higher than expected.	IMDRF:A090807
C54451	CDRH Medical Device Problem Code Terminology	C63046	Low Readings	Reading provided by the device is too low or lower than expected.	Low Readings	2460	Reading provided by the device is too low or lower than expected.	IMDRF:A090808
C54451	CDRH Medical Device Problem Code Terminology	C63122	High Test Results	Test results provided by the device are too high or higher than expected.	High Test Results	2457	Test results provided by the device are too high or higher than expected.	IMDRF:A090809
C54451	CDRH Medical Device Problem Code Terminology	C63045	Low Test Results	Test results provided by the device are too low or lower than expected.	Low Test Results	2458	Test results provided by the device are too low or lower than expected.	IMDRF:A090810
C54451	CDRH Medical Device Problem Code Terminology	C62826	Unable to Obtain Readings	The device does not provide or display a valid reading.	Unable to Obtain Readings	1516	The device does not provide or display a valid reading.	IMDRF:A090811
C54451	CDRH Medical Device Problem Code Terminology	C95878	Missing Test Results	Problem associated with the results of a test or measurement not appearing.	Missing Test Results	3267	Problem associated with the results of a test or measurement not appearing.	IMDRF:A090812
C54451	CDRH Medical Device Problem Code Terminology	C172080	Erratic Results	Erroneous/discrepant results which combine high/low and/or positive/negative results.	Erratic Results	4059	Reports of erroneous/discrepant results which combine high/low and/or positive/negative results. This term is not to be selected where reports indicate consistently high or low or false positive or false negative results.	IMDRF:A090813
C54451	CDRH Medical Device Problem Code Terminology	C187257	Poor Visibility	Implanted device is difficult to detect on imaging modalities, e.g. insufficient visibility.	Poor Visibility	4072	Implanted device is difficult to detect on imaging modalities, e.g. insufficient visibility.	IMDRF:A090814
C54451	CDRH Medical Device Problem Code Terminology	C62821	Unexpected Therapeutic Result	Problem associated with the use of a medical device for therapeutic purposes.	Unexpected Therapeutic Results	1631	Problem associated with the use of the device for therapeutic purposes.	IMDRF:A0909
C54451	CDRH Medical Device Problem Code Terminology	C62922	Temperature Problem	Problem associated with the device producing unintended temperatures.	Temperature Problem	3022	Problem associated with the device producing unintended temperatures.	IMDRF:A10
C54451	CDRH Medical Device Problem Code Terminology	C63202	Excessive Cooling	Problem associated with the device producing temperatures that are lower than specified.	Excessive Cooling	2932	Problem associated with the device producing temperatures that are lower than specified.	IMDRF:A1001
C54451	CDRH Medical Device Problem Code Terminology	C133576	Excessive Heating	Problem associated with the device which has a warming or heating function, and is producing excessive heat.	Excessive Heating	4030	Problem associated with the device which have a warming or heating function, producing excessive heat.	IMDRF:A1002
C54451	CDRH Medical Device Problem Code Terminology	C63071	Insufficient Cooling	Problem associated with the device insufficiently cooled in device active (working) or/and non-active (nonworking) state.	Insufficient Cooling	1130	Problem associated with the device insufficiently cooled in device active (working) or/and non-active (nonworking) state.	IMDRF:A1003
C54451	CDRH Medical Device Problem Code Terminology	C63070	Insufficient Heating	Problem associated with the device or its components producing temperatures that are not as high as what is specified.	Insufficient Heating	1287	Problem associated with the device or its components producing temperatures that are not as high as what is specified.	IMDRF:A1004
C54451	CDRH Medical Device Problem Code Terminology	C62883	Overheating of Device	Problem associated with the device producing high temperatures, such that its operation is compromised or harm is caused (e.g. overheating that produces melting of components or automatic shutdown).	Overheating of Device	1437	Problem associated with the device producing high temperatures, such that its operation is compromised or harm is caused (e.g. overheating that produces melting of components or automatic shutdown).	IMDRF:A1005
C54451	CDRH Medical Device Problem Code Terminology	C63286	Thermal Decomposition of Device	Problems associated with a discoloration or destruction as a result of thermal decomposition of the device.	Thermal Decomposition of Device	1071	Problems associated with a discoloration or destruction as a result of thermal decomposition of the device.	IMDRF:A1006
C54451	CDRH Medical Device Problem Code Terminology	C63143	Device Fire	Problem associated with the combustion of the device with a steady flame.	Fire	1245	Problem associated with the combustion of the device with a steady flame.	IMDRF:A1007
C54451	CDRH Medical Device Problem Code Terminology	C63140	Flare or Flash	Problem associated with the device-related burn with an unsteady flame.	Flare or Flash	2942	Problem associated with device-related burn with an unsteady flame.	IMDRF:A1008
C54451	CDRH Medical Device Problem Code Terminology	C63003	Device Smoking	Problem associated with a cloud of vapor or gas generated from the device, generally associated after a fire or a burn.	Smoking	1585	Problem associated with a cloud of vapor or gas generated from the device, generally associated after a fire or a burn.	IMDRF:A1009
C54451	CDRH Medical Device Problem Code Terminology	C63269	Computer Software Problem	Issue associated with written programs, codes, and/or software system that affects device performance or communication with another device.	Computer Software Problem	1112	Problem associated with written programs, codes, and/or software system that affects device performance or communication with another device.	IMDRF:A11
C54451	CDRH Medical Device Problem Code Terminology	C64349	Application Network Problem	Problem associated with the deviations from documented system specifications that affects overall system performance and/or the performance of an individual medical device connected to that system.	Application Network Problem	2879	Problem associated with the deviations from documented system specifications that affects overall system performance and/or the performance of an individual device connected to that system.	IMDRF:A1101
C54451	CDRH Medical Device Problem Code Terminology	C63305	Application Program Problem	Problem associated with the requirement for software to fulfill its function within an intended use or application.	Application Program Problem	2880	Problem associated with the requirement for software to fulfill its function within an intended use or application.	IMDRF:A1102
C54451	CDRH Medical Device Problem Code Terminology	C133578	Application Program Freezes, Becomes Nonfunctional	Problem associated with freezing and/or becoming nonfunctional of an application program.	Application Program Freezes, Becomes Nonfunctional	4031	Problem associated with freezing and/or becoming nonfunctional of an application program.	IMDRF:A110201
C54451	CDRH Medical Device Problem Code Terminology	C63220	Dose Calculation Error in Application Program	Problem associated with the written program code or application software used by a device to calculate specific measurements or quantities managed by the device.	Application Program Problem: Dose Calculation Error	1189	Problem associated with the written program code or application software used by the device to calculate specific measurements or quantities managed by the device.	IMDRF:A110202
C54451	CDRH Medical Device Problem Code Terminology	C91396	Medication Error due to Application Program Problem	An error in medication preparation or administration attributed to software.	Application Program Problem: Medication Error	3198	Event in which the device software results in errors of medication preparation or administration.	IMDRF:A110203
C54451	CDRH Medical Device Problem Code Terminology	C63083	Parameter Calculation Error due to Application Program Problem	Problem associated with the written program code or application software used by a device to calculate parameters other than those related to dose or power.	Application Program Problem: Parameter Calculation Error	1449	Problem associated with the written program code or application software used by the device to calculate parameters other than those related to dose or power.	IMDRF:A110204
C54451	CDRH Medical Device Problem Code Terminology	C62916	Power Calculation Error due to Application Program Problem	Problem associated with the written program code or application software used by a device for calculations related to device power.	Application Program Problem: Power Calculation Error	1473	Problem associated with the written program code or application software used by the device for calculations related to device power.	IMDRF:A110205
C54451	CDRH Medical Device Problem Code Terminology	C63304	Application Program Version or Upgrade Problem	Problem associated with installing updates to a software system that affects a device performance or communication with another device.	Application Program Version or Upgrade Problem	2881	Problem associated with installing updates to a software system that affects the device performance or communication with another device.	IMDRF:A110206
C54451	CDRH Medical Device Problem Code Terminology	C67507	Problem with Software Installation	Problem associated with installing a medical device software in a manner that allows full functioning of a medical device. Source of installation could be manufacturer or user.	Problem with Software Installation	3013	Problem associated with installing the device software in a manner that allows full functioning of the device. Source of installation could be manufacturer or user.	IMDRF:A110207
C54451	CDRH Medical Device Problem Code Terminology	C133594	Unintended Application Program Shut Down	Problem associated with an unintended shut down by malfunction of the application program.	Unintended Application Program Shut Down	4032	Problem associated with an unintended shut down by malfunction of the application program.	IMDRF:A110208
C54451	CDRH Medical Device Problem Code Terminology	C133593	Program or Algorithm Execution Problem	Problem associated with execution problems relating to program or algorithm.	Program or Algorithm Execution Problem	4033	Problem associated with execution problems relating to program or algorithm.	IMDRF:A1103
C54451	CDRH Medical Device Problem Code Terminology	C133599	Delayed Program or Algorithm Execution	Problem associated with a delayed execution relating to program or algorithm.	Delayed Program or Algorithm Execution	4034	Problem associated with delayed execution relating to program or algorithm.	IMDRF:A110301
C54451	CDRH Medical Device Problem Code Terminology	C133603	Intermittent Program or Algorithm Execution	Problem associated with intermittent execution relating to program or algorithm.	Intermittent Program or Algorithm Execution	4035	Problem associated with intermittent execution relating to program or algorithm.	IMDRF:A110302
C54451	CDRH Medical Device Problem Code Terminology	C133625	Program or Algorithm Execution Failure	Problem associated with the failure of a program or algorithm to execute. Sudden /unexpected interruption to a program's execution.	Program or Algorithm Execution Failure	4036	Problem associated with the failure of a program or algorithm to execute. Sudden/unexpected interruption to a program's execution.	IMDRF:A110303
C54451	CDRH Medical Device Problem Code Terminology	C63270	Computer Operating System Problem	Problem associated with software, firmware, and/or hardware elements that control the execution of computer programs and provides such services as computer resource allocation, job control, input/output control, and file management in a computer system.	Computer Operating System Problem	2898	Problem associated with software, firmware, and/or hardware elements that control the execution of computer programs and provides such services as computer resource allocation, job control, input/output control, and file management in a computer system.	IMDRF:A1104
C54451	CDRH Medical Device Problem Code Terminology	C62894	Operating System Interface Becomes Non-Functional	Problem associated with malfunction of the computer operating system as opposed to an application software problem.	Operating System Becomes Nonfunctional	2996	Problem associated with malfunction of the computer operating system as opposed to an application software problem.	IMDRF:A110401
C54451	CDRH Medical Device Problem Code Terminology	C62893	Operating System Version or Upgrade Problem	Problem associated with replacing an older operating system to an up-to-date operating system.	Operating System Version or Upgrade Problem	2997	Problem associated with replacing an older operating system to an up-to-date operating system.	IMDRF:A110402
C54451	CDRH Medical Device Problem Code Terminology	C64348	Computer System Security Problem	Problem associated with unauthorized access to or modification of a software system resulting in a loss of confidentiality, integrity, or availability of written program code, application software, or data or entire device.	Computer System Security Problem	2899	Problem associated with unauthorized access to or modification of a software system resulting in a loss of confidentiality, integrity, or availability of written program code, application software, or data or entire device.	IMDRF:A1105
C54451	CDRH Medical Device Problem Code Terminology	C63042	Application Security Problem	Problem associated with the acquisition of computer programming codes that can replicate and spread from one computer system to another thereby leading to damaged software, hardware and data.	Application Security Problem	2882	Problem associated with the acquisition of computer programming codes that can replicate and spread from one computer system to another thereby leading to damaged software, hardware and data.	IMDRF:A110501
C54451	CDRH Medical Device Problem Code Terminology	C63259	Unauthorized Access to Computer System	Problem associated with an access that was not permitted to the computer system that may lead to modification of program, corruption of data, or and break in network security. This concept is closely associated with computer integrity which is the degree to which a system or component prevents unauthorized access to, or modification of, computer programs or data.	Unauthorized Access to Computer System	3025	Problem associated with an access that was not permitted to the computer system that may lead to modification of program, corruption of data, or and break in network security. This concept is closely associated with computer integrity which is the degree to which a system or component prevents unauthorized access to, or modification of, computer programs or data.	IMDRF:A110502
C54451	CDRH Medical Device Problem Code Terminology	C63258	Data Back-Up Problem	Problems relating to a system, component, file, procedure, or person available to replace or help restore a primary item in the event of a failure or externally caused disaster.	Data Back-Up Problem	2902	Problems relating to a system, component, file, procedure, or person available to replace or help restore a primary item in the event of a failure or externally caused disaster.	IMDRF:A1106
C54451	CDRH Medical Device Problem Code Terminology	C63195	Failure to Back-Up	Problem associated with the inability to backup or to retrieve a backed up version (corrupted file) of device data or system files.	Failure to Back-Up	1047	Problem associated with the inability to backup or to retrieve a backed up version (corrupted file) of device data or system files.	IMDRF:A110601
C54451	CDRH Medical Device Problem Code Terminology	C63189	Failure to Convert to Back-Up	Problem associated with a failure to transition from a primary system, component, file, procedure to a backup in response to a failure in the primary item.	Failure to Convert to Back-Up	1048	Problem associated with a failure to transition from a primary system, component, file, procedure to a backup in response to a failure in the primary item.	IMDRF:A110602
C54451	CDRH Medical Device Problem Code Terminology	C91397	Data Problem	Event in which data (charting, orders, results) is not correctly stored, transferred, updated, or displayed.	Data Problem	3196	Event in which data (charting, orders, results) is not correctly stored, transferred, updated, or displayed.	IMDRF:A1107
C54451	CDRH Medical Device Problem Code Terminology	C63257	Loss of Data	Event in which data is unintentionally permanently or temporarily lost, deleted, corrupted, or overwritten.	Loss of Data	2903	Event in which data is unintentionally permanently or temporarily lost, deleted, corrupted, or overwritten.	IMDRF:A110701
C54451	CDRH Medical Device Problem Code Terminology	C91398	Patient Data Problem	Event in which data is accessed by the healthcare provider and either the wrong patient or the wrong data is retrieved despite correct inquiry procedures.	Patient Data Problem	3197	Event in which data is accessed by the healthcare provider and either the wrong patient or the wrong data is retrieved despite correct inquiry procedures.	IMDRF:A110702
C54451	CDRH Medical Device Problem Code Terminology	C67508	Date-Related Software Issue	Problem associated with programming of calendar dates and/or time as a factor in the operation of the device.	Date/Time-Related Software Problem	2582	Problem associated with programming of calendar dates and/or time as a factor in the operation of the device.	IMDRF:A1108
C54451	CDRH Medical Device Problem Code Terminology	C62952	Connection Problem	Problem associated with linking of a device and/or the functional units set up to provide means for a transfer of liquid, gas, electricity or data.	Connection Problem	2900	Problem associated with linking of the device and/or the functional units set up to provide means for a transfer of liquid, gas, electricity or data.	IMDRF:A12
C54451	CDRH Medical Device Problem Code Terminology	C63288	Blocked Connection	Problem associated with linking of a device whereby their functional units set up to provide means for a transfer of fluid, gas, or data is prevented or impeded.	Blocked Connection	2888	Problem associated with linking of the device whereby their functional units set up to provide means for a transfer of fluid, gas, or data is prevented or impeded.	IMDRF:A1201
C54451	CDRH Medical Device Problem Code Terminology	C63256	Decoupling	Problem associated with the device being unassociated in such a way that fluid, gas, power or signal information may not be transferred from one device to another.	Decoupling	1145	Problem associated with the device being unassociated in such a way that fluid, gas, power or signal information may not be transferred from one to another.	IMDRF:A1202
C54451	CDRH Medical Device Problem Code Terminology	C63223	Disconnection	Problem associated with the linking of the device having a sufficient open space to prevent gas, liquid or electrical current flow between connectors.	Disconnection	1171	Problem associated with the linking of the device having a sufficient open space to prevent gas, liquid or electrical current flow between connectors.	IMDRF:A1203
C54451	CDRH Medical Device Problem Code Terminology	C63180	Failure to Disconnect	Problem associated with the linking of the device whereby termination of the transfer of liquid, gas, electricity, or information cannot be accomplished, or linking components do not come apart, or disconnect, when expected.	Failure to Disconnect	2541	Problem associated with the linking of the device whereby termination of the transfer of liquid, gas, electricity, or information cannot be accomplished, or linking components do not come apart, or disconnect, when expected.	IMDRF:A1204
C54451	CDRH Medical Device Problem Code Terminology	C63055	Loose Connection	Problem associated with the connection of the device being loose or intermittent.	Loose or Intermittent Connection	1371	Problem associated with the connection of the device being loose or intermittent.	IMDRF:A1205
C54451	CDRH Medical Device Problem Code Terminology	C62915	Misconnection	Problem associated with the connection of the device being improper or not in accordance with device specification, requirements or intended uses.	Misconnection	1399	Problem associated with the connection of the device being improper or not in accordance with device specification, requirements or intended uses.	IMDRF:A1206
C54451	CDRH Medical Device Problem Code Terminology	C133626	Incomplete or Inadequate Connection	Problem associated with a partial linking of the device whereby the device may appear to be connected however only a partial, intermittent or no transfer of liquid, gas, electricity, or information can be accomplished.	Incomplete or Inadequate Connection	4037	Problem associated with a partial linking of the device whereby device may appear to be connected however only a partial, intermittent or no transfer of liquid, gas, electricity, or information can be accomplished.	IMDRF:A1207
C54451	CDRH Medical Device Problem Code Terminology	C63142	Fitting Problem	Problem associated with the connection of the device whereby channels, switching systems, and other functional units set up to provide means for a transfer of liquid, gas, electricity, or information do not match or fit.	Fitting Problem	2183	Problem associated with the connection of the device whereby channels, switching systems, and other functional units set up to provide means for a transfer of liquid, gas, electricity, or information do not match or fit.	IMDRF:A1208
C54451	CDRH Medical Device Problem Code Terminology	C63271	Communication or Transmission Problem	Problem associated with a device sending or receiving signals or data. This includes transmission among internal components of the device to which the device is intended to communicate.	Communication or Transmission Problem	2896	Problem associated with the device sending or receiving signals or data. This includes transmission among internal components of the device to which the device is intended to communicate.	IMDRF:A13
C54451	CDRH Medical Device Problem Code Terminology	C63164	Failure to Read Input Signal	Problem associated with a failure of the device to read a signal for interpretation or measurement.	Failure to Read Input Signal	1581	Problem associated with a failure of the device to read a signal for interpretation or measurement.	IMDRF:A1301
C54451	CDRH Medical Device Problem Code Terminology	C63155	Failure to Transmit Record	Problem associated with a failure of the device to transmit a record for interpretation or measurement.	Failure to Transmit Record	1521	Problem associated with a failure of the device to transmit a record for interpretation or measurement.	IMDRF:A1302
C54451	CDRH Medical Device Problem Code Terminology	C133627	Intermittent Communication Failure	Inconsistent or lack of intended communication of data among internal components or with other external devices.	Intermittent Communication Failure	4038	Inconsistent or lack of intended communication of data among internal components or with other external devices.	IMDRF:A1303
C54451	CDRH Medical Device Problem Code Terminology	C62830	Telemetry Discrepancy	Problem associated with variability of the transmission of telemetry signals.	Telemetry Discrepancy	1629	Problem associated with variability of the transmission of telemetry signals.	IMDRF:A1304
C54451	CDRH Medical Device Problem Code Terminology	C104820	Wireless Communication Problem	Problems with the RF wireless technology characteristics and performance (e.g., frequency, output power, range, reception), wireless quality of service, wireless coexistence, security of wireless signals and data, and electromagnetic compatibility.	Wireless Communication Problem	3283	Problems with the RF wireless technology characteristics and performance (e.g., frequency, output power, range, reception), wireless quality of service, wireless coexistence, security of wireless signals and data, and electromagnetic compatibility.	IMDRF:A1305
C54451	CDRH Medical Device Problem Code Terminology	C63075	Infusion or Flow Problem	Problem associated with the device failing to deliver liquids or gases as intended (e.g. delivering drugs at incorrect rate, problems with drawing fluid from a system.)	Infusion or Flow Problem	2964	Problem associated with the device failing to deliver or draw liquids or gases as intended (e.g. delivering drugs at incorrect rate, Problems with drawing fluid from a system). This includes vacuum collection devices.	IMDRF:A14
C54451	CDRH Medical Device Problem Code Terminology	C63249	Deflation Problem	Problem associated with the inability of the device to release its contents.	Deflation Problem	1149	Problem associated with the deflation of the device including unintended deflation or inadequate deflation.	IMDRF:A1401
C54451	CDRH Medical Device Problem Code Terminology	C172081	Failure to Deflate Problem	Problem associated with the inability to deflate a device which is intended to deflate.	Failure to Deflate	4060	Problem associated with the inability to deflate a device which is intended to deflate.	IMDRF:A140101
C54451	CDRH Medical Device Problem Code Terminology	C172082	Unintended Deflation	Problem associated with the unintended deflation of a device which was not designed to deflate or not at that point in time or not to that extent.	Unintended Deflation	4061	Problem associated with the unintended deflation of a device which was not designed to deflate or not at that point in time or not to that extent.	IMDRF:A140102
C54451	CDRH Medical Device Problem Code Terminology	C62882	Excess Flow or Overinfusion	Problem associated with a delivery overdose of therapeutic agents, such as drugs or fluids being delivered into a device or a patient.	Excess Flow or Over-Infusion	1311	Problem associated with a delivery overdose of therapeutic agents, such as drugs or fluids being delivered into a device or a patient.	IMDRF:A1402
C54451	CDRH Medical Device Problem Code Terminology	C63144	Filling Problem	Problem associated with the method or amount of time associated with the delivery of a fluid. Time to delivery or amount of delivered entity may be affected.	Filling Problem	1233	Problem associated with the method or amount of time associated with the delivery of a fluid. Time to delivery or amount of delivered entity may be affected.	IMDRF:A1403
C54451	CDRH Medical Device Problem Code Terminology	C63106	Inability to Autofill	Complete failure to fill as part of an automated process. For insufficient filling use Short Fill. For excessive filling use Overfill. For inconsistent filling use Volume Accuracy Problem.	Inability to Auto-Fill	1044	Complete failure to fill as part of an automated process. For insufficient filling use "Short Fill". For excessive filling use "Overfill". For inconsistent filling use "Volume Accuracy Problem".	IMDRF:A140301
C54451	CDRH Medical Device Problem Code Terminology	C62884	Overfill	Excessive filling of a device. For complete failure to fill use inability to auto-fill. For insufficient filling use Short Fill. For inconsistent filling - use Volume Accuracy Problem.	Overfill	2404	Excessive filling of a device. For complete failure to fill use "inability to auto-fill". For insufficient filling use "Short Fill". For inconsistent filling use "Volume Accuracy Problem".	IMDRF:A140302
C54451	CDRH Medical Device Problem Code Terminology	C62841	Short Fill	Insufficient filling of a device. For complete failure to fill use inability to auto-fill. For insufficient filling use short fill. For inconsistent filling - use Volume Accuracy Problem.	Short Fill	1575	Insufficient filling of a device. For complete failure to fill use "inability to auto-fill". For insufficient filling use "short fill". For inconsistent filling use "Volume Accuracy Problem".	IMDRF:A140303
C54451	CDRH Medical Device Problem Code Terminology	C62805	Volume Accuracy Problem	Inconsistent filling of a device. This describes a problem which is observed to vary between overfilling and under filling, and may be intermittent. Use Overfill or Short Fill if problem is consistent.	Volume Accuracy Problem	1675	Inconsistent filling of a device. This describes a problem which is observed to vary between overfilling and under filling, and may be intermittent. Use "Overfill" or "Short Fill" if problem is consistent.	IMDRF:A140304
C54451	CDRH Medical Device Problem Code Terminology	C62986	Filtration Issue	Problem associated with the process of passing a substance through a porous medium, e.g., a blood clot filter for the removal of suspended matter.	Filtration Problem	2941	Problem associated with the process of passing a substance through a porous medium, e.g., a blood clot filter for the removal of suspended matter.	IMDRF:A1404
C54451	CDRH Medical Device Problem Code Terminology	C62985	Inadequate Filtration Process	Problem associated with the filter failing to remove items or substances which should have been removed.	Inadequate Filtration Process	2308	Problem associated with the filter failing to remove items or substances which should have been removed.	IMDRF:A140401
C54451	CDRH Medical Device Problem Code Terminology	C62827	Inadequate Ultrafiltration	Problem associated with the transfer of fluid between the blood and dialysate through the dialysis membrane due to a pressure gradient (trans-membrane pressure) existing between the blood and dialysate compartments.	Inadequate Ultra Filtration	1656	Problem associated with the transfer of fluid between the blood and dialysate through the dialysis membrane due to a pressure gradient (trans-membrane pressure) existing between the blood and dialysate compartments.	IMDRF:A140402
C54451	CDRH Medical Device Problem Code Terminology	C63110	Improper Flow or Infusion	Problem associated with the regulation and delivery of therapeutic agents (e.g. air, gas, drugs or fluids into a device or a patient under positive pressure).	Improper Flow or Infusion	2954	Problem associated with the regulation and delivery of therapeutic agents (e.g. air, gas, drugs or fluids into a device or a patient under positive pressure).	IMDRF:A1405
C54451	CDRH Medical Device Problem Code Terminology	C63290	Backflow	Continuous flow of fluid (e.g. liquid, gas) against the intended flow direction.	Backflow	1064	Continuous flow of fluid (e.g. liquid, gas) against the intended flow direction.	IMDRF:A140501
C54451	CDRH Medical Device Problem Code Terminology	C63130	Free or Unrestricted Flow	Problem associated with uncontrolled flow of infusion of air, gas or fluids.	Free or Unrestricted Flow	2945	Problem associated with uncontrolled flow of infusion of air, gas or fluids.	IMDRF:A140502
C54451	CDRH Medical Device Problem Code Terminology	C63126	Gradient Increase	Problem associated with the increased rate of change in temperature, pressure, or other variables as a function of distance, time, etc.	Gradient Increase	1270	Problem associated with the increased rate of change in temperature, pressure, or other variables as a function of distance, time, etc.	IMDRF:A140503
C54451	CDRH Medical Device Problem Code Terminology	C63104	Inaccurate Delivery	Delivery at endpoint not as intended; either too low or too high.	Inaccurate Delivery	2339	Delivery at endpoint not as intended; either too low or too high.	IMDRF:A140504
C54451	CDRH Medical Device Problem Code Terminology	C63102	Inaccurate Flow Rate	Problem associated with fluctuations in the flow volume delivered per time, even if end volume is correct, and delivered in the correct total time.	Inaccurate Flow Rate	1249	Problem associated with fluctuations in the flow volume delivered per time, even if end volume is correct, and delivered in the correct total time.	IMDRF:A140505
C54451	CDRH Medical Device Problem Code Terminology	C63067	Intermittent Infusion	Problem associated with the infusion not being steady, characterized by intermittent stoppages to the flow.	Intermittent Infusion	2341	Problem associated with the infusion not being stead- characterised by intermittent stoppages to the flow.	IMDRF:A140506
C54451	CDRH Medical Device Problem Code Terminology	C62854	Reflux within Device	Problem associated with partial backflow, compromising the device's flow output.	Reflux within Device	1522	Problem associated with partial backflow, compromising the device's flow output.	IMDRF:A140507
C54451	CDRH Medical Device Problem Code Terminology	C62849	Restricted Flow Rate	Problem associated with flow rate. Flow volume delivered over time is not reaching intended flow rate.	Restricted Flow rate	1248	Problem associated with flow rate. Flow volume delivered over time is not reaching intended flow rate.	IMDRF:A140508
C54451	CDRH Medical Device Problem Code Terminology	C63138	Tidal Volume Fluctuations	Problem associated with the amount of gas that is inspired and expired during one respiratory cycle.	Tidal Volume Fluctuations	1634	Problem associated with the amount of gas that is inspired and expired during one respiratory cycle.	IMDRF:A140509
C54451	CDRH Medical Device Problem Code Terminology	C63076	Inflation Problem	Problem associated with the inability of the device to expand or enlarge with the intended inflation agent (e.g. saline or air).	Inflation Problem	1310	Problem associated with the inability of the device to expand or enlarge with the intended inflation agent (e.g. saline or air).	IMDRF:A1406
C54451	CDRH Medical Device Problem Code Terminology	C62823	Insufficient Flow or Underinfusion	Problem associated with an insufficient dose of therapeutic agents, e.g., drugs or fluids being delivered into a patient under positive pressure.	Insufficient Flow or Under Infusion	2182	Problem associated with an insufficient dose of therapeutic agents, e.g., drugs or fluids being delivered into a patient under positive pressure.	IMDRF:A1407
C54451	CDRH Medical Device Problem Code Terminology	C62902	No Flow	Problem arising from the device failing to deliver the specified liquid or gas.	No Flow	2991	Problem arising from the device failing to deliver the specified liquid or gas.	IMDRF:A1408
C54451	CDRH Medical Device Problem Code Terminology	C63186	Failure to Deliver	Failure (=complete nonperformance) with regard to the intended function of delivery.	Failure to Deliver	2338	Failure (=complete nonperformance) with regard to the intended function of delivery.	IMDRF:A140801
C54451	CDRH Medical Device Problem Code Terminology	C63174	Failure to Infuse	Failure (=complete nonperformance) with regard to the intended function of infusion.	Failure to Infuse	2340	Failure (=complete nonperformance) with regard to the intended function of infusion.	IMDRF:A140802
C54451	CDRH Medical Device Problem Code Terminology	C63105	Inability to Irrigate	Failure (=complete nonperformance) with regard to the intended function of irrigation.	Inability to Irrigate	1337	Failure (=complete nonperformance) with regard to the intended function of irrigation.	IMDRF:A140803
C54451	CDRH Medical Device Problem Code Terminology	C62897	Obstruction of Flow	Problem related to an obstruction or blockage within the device component (e.g. tube, opening, pipe) that results in restriction of flow.	Obstruction of Flow	2423	Problem related to an obstruction or blockage within the device component (e.g. tube, opening, pipe) that results in restriction of flow (including blood clotting).	IMDRF:A1409
C54451	CDRH Medical Device Problem Code Terminology	C63024	Complete Blockage Device	Problem related to an obstruction or blockage within the device component (e.g. tube, opening, pipe) that results in no flow.	Complete Blockage	1094	Problem related to an obstruction or blockage within the device component (e.g. tube, opening, pipe) that results in no flow.	IMDRF:A140901
C54451	CDRH Medical Device Problem Code Terminology	C63289	Partial Blockage	Problem related to an obstruction or blockage within the device component (e.g. tube, opening, pipe) that results in a reduction of the flow rate.	Partial Blockage	1065	Problem related to an obstruction or blockage within the device component (e.g. tube, opening, pipe) that results in a reduction of the flow rate.	IMDRF:A140902
C54451	CDRH Medical Device Problem Code Terminology	C63317	Difficult to Flush	The device that is difficult to flush, possibly indicating an obstruction within device.	Difficult to Flush	1251	The device is difficult to flush, possibly indicating an obstruction within device.	IMDRF:A1410
C54451	CDRH Medical Device Problem Code Terminology	C62934	Pressure Issue	Problem associated with the application of a force either internal or external to device that compromises the flow of fluid or gas.	Pressure Problem	3012	Problem associated with the application of a force either internal or external to device that compromises the flow of fluid or gas.	IMDRF:A1411
C54451	CDRH Medical Device Problem Code Terminology	C63255	Decrease in Device Pressure	Unintended decrease in pressure, compromising a medical device's intended function.	Decrease in Pressure	1490	Unintended decrease in pressure, compromising the device's intended function.	IMDRF:A141101
C54451	CDRH Medical Device Problem Code Terminology	C63080	Increase in Pressure	Unintended increase in pressure, compromising the device's intended function.	Increase in Pressure	1491	Unintended increase in pressure, compromising the device's intended function.	IMDRF:A141102
C54451	CDRH Medical Device Problem Code Terminology	C64243	No Pressure	Unintended complete loss of pressure, compromising the device's intended function.	No Pressure	2994	Unintended complete loss of pressure, compromising the device's intended function.	IMDRF:A141103
C54451	CDRH Medical Device Problem Code Terminology	C62860	Pumping Problem	Problem associated with pump performance deviating from specifications in a way to compromise flow or infusion.	Pumping Problem	3016	Problem associated with pump performance deviating from specifications in a way to compromise flow or infusion.	IMDRF:A1412
C54451	CDRH Medical Device Problem Code Terminology	C63252	Decreased Pump Speed	Unintended decrease in pump speed and subsequent flow rate, compromising the intended function of a medical device.	Decreased Pump Speed	1500	Unintended decrease in pump speed and hence, probably, flow rate, compromising the intended function of the device.	IMDRF:A141201
C54451	CDRH Medical Device Problem Code Terminology	C63077	Increased Pump Speed	Unintended increase in pump speed and hence, probably, flow rate, compromising the intended function of the device.	Increased Pump Speed	1501	Unintended increase in pump speed and hence, probably, flow rate, compromising the intended function of the device.	IMDRF:A141202
C54451	CDRH Medical Device Problem Code Terminology	C63165	Failure to Pump	Problem associated with the device which fails to start pumping.	Failure to Pump	1502	Problem associated with the device which fails to start pumping.	IMDRF:A141203
C54451	CDRH Medical Device Problem Code Terminology	C62859	Pumping Stopped	Unexpected /unintended cessation of pump.	Pumping Stopped	1503	Unexpected/unintended cessation of pump.	IMDRF:A141204
C54451	CDRH Medical Device Problem Code Terminology	C62833	Suction Problem	Problem associated with suction equipment, which may be a manual, electrical, vacuum or pressure source operated to evacuate and remove undesired substances (air, gas, fluid, or particulates) via tubing and collection bag.	Suction Problem	2170	Problem associated with suction equipment, which may be a manual, electrical, vacuum or pressure source operated to evacuate and remove undesired substances (air, gas, fluid, or particulates) via tubing and collection bag.	IMDRF:A1413
C54451	CDRH Medical Device Problem Code Terminology	C63254	Decrease in Suction	Problem associated with the removal of fluid or gas from a body cavity due to decreased suction.	Decrease in Suction	1146	Problem associated with the removal of fluid or gas from a body cavity or device due to decreased suction.	IMDRF:A141301
C54451	CDRH Medical Device Problem Code Terminology	C63079	Increase in Suction	Problem associated with the removal of excess fluid or gas from a body cavity due to increased suction.	Increase in Suction	1604	Problem associated with the removal of fluid or gas from a body cavity or device due to increased suction.	IMDRF:A141302
C54451	CDRH Medical Device Problem Code Terminology	C133628	Suction Failure	Problem associated with the complete inability to provide suction.	Suction Failure	4039	Problem associated with the complete inability to provide suction.	IMDRF:A141303
C54451	CDRH Medical Device Problem Code Terminology	C133629	Priming Problem	Problem associated with the preparation of the device to begin pumping.	Priming Problem	4040	Problem associated with the preparation of the device to begin pumping.	IMDRF:A1414
C54451	CDRH Medical Device Problem Code Terminology	C63167	Failure to Prime	Problem associated with the device failing to begin the priming process (i.e. the process of preparation of device for the delivery of fluids).	Failure to Prime	1492	Problem associated with the device failing to begin the priming process (i.e. the process of preparation of device for the delivery of fluids).	IMDRF:A141401
C54451	CDRH Medical Device Problem Code Terminology	C133630	Incomplete or Inadequate Priming	Problem associated with not adequately preparing the device.	Incomplete or Inadequate Priming	4041	Problem associated with not adequately preparing the device.	IMDRF:A141402
C54451	CDRH Medical Device Problem Code Terminology	C172083	Air/Gas in Device	Problem associated with air in the device (e.g. air in line).	Air/Gas in Device	4062	Problem associated with air in the device (e.g. air in line).	IMDRF:A1415
C54451	CDRH Medical Device Problem Code Terminology	C63013	Activation, Positioning or Separation Problem	Problem associated with any deviations from the documented specifications of a medical device that relate to the sequence of events for activation, positioning or separation of device.	Activation, Positioning or Separation Problem	2906	Problem associated with any deviations from the documented specifications of the device that relate to the sequence of events for activation, positioning or separation of device. Note: Deployment is synonymous with activation.	IMDRF:A15
C54451	CDRH Medical Device Problem Code Terminology	C133631	Activation Problem	Problem associated with the activation of a device.	Activation Problem	4042	Problem associated with the activation of the device. Note: Activation includes expansion.	IMDRF:A1501
C54451	CDRH Medical Device Problem Code Terminology	C96715	Activation Failure Including Expansion Failures	Problem associated with the device failing to be activated including expansion.	Activation Failure	3270	Problem associated with the device failing to be activated including partial activation.	IMDRF:A150101
C54451	CDRH Medical Device Problem Code Terminology	C63035	Activation Difficult or Delayed	Problem associated with delayed or difficult activation of the device.	Difficult or Delayed Activation	2577	Problem associated with delayed or difficult activation of the device.	IMDRF:A150102
C54451	CDRH Medical Device Problem Code Terminology	C62863	Premature Activation	Problem associated with early and unexpected activation of the device.	Premature Activation	1484	Problem associated with early and unexpected activation of the device.	IMDRF:A150103
C54451	CDRH Medical Device Problem Code Terminology	C62844	Self-Activation or Keying	Problem associated with the unintended activation of the device, or a  device having been unexpectedly turned on during use.	Self-Activation or Keying	1557	Problem associated with the unintended activation of the device, or the device having been unexpectedly turned on during use.	IMDRF:A150104
C54451	CDRH Medical Device Problem Code Terminology	C172084	Key or Button Unresponsive/not Working	Problem associated with a device not responding to key or button inputs.	Key or Button Unresponsive/not Working	4063	Problem associated with a device not responding to key or button inputs.	IMDRF:A150105
C54451	CDRH Medical Device Problem Code Terminology	C63034	Position Problem	Problem associated with the movement of the device to an intended location.	Positioning Problem	3009	Problem associated with the movement of the device to an intended location.	IMDRF:A1502
C54451	CDRH Medical Device Problem Code Terminology	C63183	Failure to Deploy	Problem associated with the inability of the medical device to be positioned in a specified location.	Positioning Failure	1158	Problem associated with the inability of the device to be positioned in a specified location.	IMDRF:A150201
C54451	CDRH Medical Device Problem Code Terminology	C63043	Malposition of Device	Problem associated with the device being positioned in a location other than intended or specified.	Malposition of Device	2616	Problem associated with the device being positioned in a location other than intended or specified.	IMDRF:A150202
C54451	CDRH Medical Device Problem Code Terminology	C63244	Difficult or Delayed Positioning	Problem associated with users experiencing difficulty or delay to position the device to a specified location.	Difficult or Delayed Positioning	1157	Problem associated with users experiencing difficulty or delay to position the device to a specified location.	IMDRF:A150203
C54451	CDRH Medical Device Problem Code Terminology	C63198	Failure to Advance	Problem associated with failure to move the device to an intended location.	Failure to Advance	2524	Problem associated with failure to move the device to an intended location.	IMDRF:A150204
C54451	CDRH Medical Device Problem Code Terminology	C63235	Difficult to Advance	Problem associated with difficulty moving the device to an intended location (e.g. difficulty in advancing guide wire).	Difficult to Advance	2920	Problem associated with difficulty moving the device to an intended location (e.g. difficulty in advancing guide wire).	IMDRF:A150205
C54451	CDRH Medical Device Problem Code Terminology	C63233	Difficult to Insert	Problem associated with problems introducing or inserting the device, even if the user is operating the device in accordance with the instructions for use or labeling.	Difficult to Insert	1316	Problem associated with problems introducing or inserting the device, even if the user is operating the device in accordance with the instructions for use or labeling.	IMDRF:A150206
C54451	CDRH Medical Device Problem Code Terminology	C63228	Difficult to Remove	Problem associated with the use of the device in terms of user experiencing difficulty to take out or get rid of the device, even if the user is operating device in accordance with the instructions for use or labeling.	Difficult to Remove	1528	Problem associated with the user experiencing difficulty when taking out the device, even if the user is operating device in accordance with the instructions for use or labeling.	IMDRF:A150207
C54451	CDRH Medical Device Problem Code Terminology	C63210	Entrapment of Device	Issue associated with the device and/or device accessories caught within patient vasculature, tissue, or other device.	Entrapment of Device	1212	Problem associated with the device caught within patient vasculature, tissue, or other device.	IMDRF:A150208
C54451	CDRH Medical Device Problem Code Terminology	C133632	Separation Problem	Problem associated with the detachment or separation of device.	Separation Problem	4043	Problem associated with the detachment or separation of the device.	IMDRF:A1503
C54451	CDRH Medical Device Problem Code Terminology	C63159	Separation Failure	Problem associated with the device or one of its components failing to detach or separate as intended.	Separation Failure	2547	Problem associated with the device or one of its components failing to detach or separate as intended.	IMDRF:A150301
C54451	CDRH Medical Device Problem Code Terminology	C133633	Difficult or Delayed Separation	Problem associated with users experiencing difficulty or delay with detachment or separation of the device.	Difficult or Delayed Separation	4044	Problem associated with users experiencing difficulty or delay with detachment or separation of the device.	IMDRF:A150302
C54451	CDRH Medical Device Problem Code Terminology	C133634	Premature Separation	Problem associated with an early and unexpected detachment or separation of the device from the system.	Premature Separation	4045	Problem associated with an early and unexpected detachment or separation of the device from the system.	IMDRF:A150303
C54451	CDRH Medical Device Problem Code Terminology	C62932	Protective Measure Problem	Problem associated with any deviations from the documented specifications of the device that relate to the implemented and inherited design features specific to devices used for reducing risks to patient or caregiver or maintaining risks within specified levels.	Protective Measures Problem	3015	Problem associated with any deviations from the documented specifications of the device that relate to the implemented and inherited design features specific to devices used for reducing risks to patient or caregiver or maintaining risks within specified levels.	IMDRF:A16
C54451	CDRH Medical Device Problem Code Terminology	C63033	Device Alarm System	Problem associated with the alarm system of the device.	Device Alarm System	1012	Problem associated with the alarm system of the device.	IMDRF:A1601
C54451	CDRH Medical Device Problem Code Terminology	C63309	Device Alarm not Visible	A device does not display an alarm message when required.	Alarm Not Visible	1022	The device does not display an alarm message when required.	IMDRF:A160101
C54451	CDRH Medical Device Problem Code Terminology	C63310	No Audible Alarm	The device fails to emit an audible alarm.	No Audible Alarm	1019	The device fails to emit an audible alarm.	IMDRF:A160102
C54451	CDRH Medical Device Problem Code Terminology	C63049	Low Audible Alarm	The audible device alarm cannot be heard clearly.	Low Audible Alarm	1016	The audible device alarm cannot be heard clearly.	IMDRF:A160103
C54451	CDRH Medical Device Problem Code Terminology	C63247	Delayed Alarm	A device alarm system operates with delay.	Delayed Alarm	1011	The device alarm system operates with delay.	IMDRF:A160104
C54451	CDRH Medical Device Problem Code Terminology	C63152	False Alarm	Problem associated with the device providing incorrect alarm warning or alert to user.	False Alarm	1013	Problem associated with the device providing incorrect alarm warning or alert to user.	IMDRF:A160105
C54451	CDRH Medical Device Problem Code Terminology	C63251	Defective Alarm	The device alarm does not operate as expected and/or in agreement with device's specifications.	Defective Alarm	1014	The device alarm does not operate as expected and/or in agreement with device's specifications.	IMDRF:A160106
C54451	CDRH Medical Device Problem Code Terminology	C62997	Fail-Safe Mechanism Problem	Problem associated with the feature that prevents the unsafe use of the device.	Fail-Safe Problem	2936	Problem associated with the feature that prevents the unsafe use of the device.	IMDRF:A1602
C54451	CDRH Medical Device Problem Code Terminology	C133635	Fail Safe did not Operate	Problem associated with the device fail-safe mechanism, which did not function or function in a non effective way, compromising safe use of the device.	Fail-Safe Did Not Operate	4046	Problem associated with the device fail-safe mechanism, which did not function or function in a non effective way, compromising safe use of the device.	IMDRF:A160201
C54451	CDRH Medical Device Problem Code Terminology	C62903	No Fail-Safe Mechanism	The device that does not have a fail-safe mechanism, although such mechanism would be required for its appropriate and/or safe functioning.	No Fail-Safe Mechanism	2990	The device does not have a fail-safe mechanism, although such mechanism would be required for its appropriate and/or safe functioning.	IMDRF:A160202
C54451	CDRH Medical Device Problem Code Terminology	C62989	Failure of Device to Self-Test	Problem associated with the device failing to perform an internal self-diagnostic process to ensure normal operation during or prior to use.	Failure of Device to Self-Test	2937	Problem associated with the device failing to perform an internal self-diagnostic process to ensure normal operation during or prior to use.	IMDRF:A1603
C54451	CDRH Medical Device Problem Code Terminology	C62995	Failure to Auto Stop	Problem associated with the inability of device to turn itself off when the device is not in an operable condition.	Failure to Auto Stop	2938	Problem associated with the inability of device to turn itself off when the device is not in an operable condition.	IMDRF:A1604
C54451	CDRH Medical Device Problem Code Terminology	C62852	Reset Issue	Problem associated with setting a variable, register, or other storage location back to a prescribed state.	Reset Problem	3019	Problem associated with setting a variable, register, or other storage location back to a prescribed state.	IMDRF:A1605
C54451	CDRH Medical Device Problem Code Terminology	C62991	Failure to Reset	Problem associated with the device failing to set a variable, register, or other storage location back to a prescribed state.	Failure to Reset	1532	Problem associated with the device failing to set a variable, register, or other storage location back to a prescribed state.	IMDRF:A160501
C54451	CDRH Medical Device Problem Code Terminology	C62987	Failure to Zero	Problem associated with the device failing to set a variable, register, or other storage location back to zero.	Failure to Zero	1683	Problem associated with the device failing to set a variable, register, or other storage location back to zero.	IMDRF:A160502
C54451	CDRH Medical Device Problem Code Terminology	C63031	Inappropriate Reset to Default	Problem associated with the device setting a variable, register, or other storage location to an inappropriate or unexpected state.	Inappropriate or Unexpected Reset	2959	Problem associated with the device setting a variable, register, or other storage location to an inappropriate or unexpected state.	IMDRF:A160503
C54451	CDRH Medical Device Problem Code Terminology	C62865	Premature Activation of Indicator	Problems with the activation of a protective measure indicator earlier than expected.	Premature Indicator Activation	3011	Problems with the activation of a protective measure indicator earlier than expected.	IMDRF:A1606
C54451	CDRH Medical Device Problem Code Terminology	C63315	Premature Elective Replacement Indicator	Problems with the early or unexpected activation of the elective replacement indicator.	Premature Elective Replacement Indicator	1483	Problems with the early or unexpected activation of the elective replacement indicator.	IMDRF:A160601
C54451	CDRH Medical Device Problem Code Terminology	C63320	Premature Activation of End-of-Life Indicator	Problem with the early or unexpected activation of the end-of-life indicator.	Premature End-of-Life Indicator	1480	Problem with the early or unexpected activation of the end-of-life indicator.	IMDRF:A160602
C54451	CDRH Medical Device Problem Code Terminology	C62842	Shielding Failure	Problem associated with the device inability to act as a barrier for absorption of radiation energy in X-rays, gamma rays, etc.	Shielding Failure	1568	Problem associated with the device inability to act as a barrier for absorption of radiation energy in X-rays, gamma rays, etc.	IMDRF:A1607
C54451	CDRH Medical Device Problem Code Terminology	C62983	Compatibility Problem	Problem associated with compatibility between device, patients or substances (medication, body fluid, etc.).	Compatibility Problem	2960	Problem associated with compatibility between device, patients or substances (medication, body fluid, etc.)	IMDRF:A17
C54451	CDRH Medical Device Problem Code Terminology	C63020	Component or Accessory Incompatibility	Problem associated with the incompatibility of any device while being operated in the same use environment thereby leading to a dysfunction between the devices.	Component or Accessory Incompatibility	2897	Problem associated with the incompatibility of any device while being operated in the same use environment thereby leading to a dysfunction between the devices.	IMDRF:A1701
C54451	CDRH Medical Device Problem Code Terminology	C63036	Accessory Incompatible	An accessory required for the intended purpose of the device appears incompatible with device, thus compromising the intended function of the device.	Accessory Incompatible	1004	An accessory required for the intended purpose of the device appears incompatible with device, thus compromising the intended function of the device.	IMDRF:A170101
C54451	CDRH Medical Device Problem Code Terminology	C63022	Component Incompatible	A component required for the proper functioning of a device is not compatible with other components or subassemblies of a device, thus compromising the intended function of a device.	Component Incompatible	1108	A component required for the proper functioning of the device is not compatible with other components or subassemblies of the device, thus compromising the intended function of the device.	IMDRF:A170102
C54451	CDRH Medical Device Problem Code Terminology	C63236	Device-Device Incompatibility	The inability of two or more devices to work together.	Device-Device Incompatibility	2919	Problem associated with the incompatibility of two or more devices while being operated in the same use environment thereby leading to a dysfunction of more than one device.	IMDRF:A1702
C54451	CDRH Medical Device Problem Code Terminology	C63040	Measurement System Incompatibility	Problem associated with the incompatibility of the measurement systems between and/or within device systems that are inherent to the individual device thereby leading to miscalculated or mismatched measurements from those devices, e.g., international metric system versus U.S. measurement system.	Measurement System Incompatibility	2982	Problem associated with the incompatibility of the measurement systems between and/or within device systems that are inherent to the individual device thereby leading to miscalculated or mismatched measurements from those devices, e.g., international metric system versus U.S. measurement system.	IMDRF:A1703
C54451	CDRH Medical Device Problem Code Terminology	C133636	Unintended Compatibility Problem	Problem associated with the ability of two or more devices which are intended to be incompatible but are able to work or fit together.	Unintended Compatibility	4047	Problem associated with the ability of two or more devices which are intended to be incompatible but are able to work or fit together.	IMDRF:A1704
C54451	CDRH Medical Device Problem Code Terminology	C63276	Contamination/Decontamination Problem	Problem associated with the presence of any unexpected foreign substance found in a device, on its surface or in the package materials, which may affect performance or intended use of the device, or problem that compromise effective decontamination of the device.	Contamination /Decontamination Problem	2895	Problem associated with the presence of any unexpected foreign substance found in the device, on its surface or in the package materials, which may affect performance or intended use of the device, or problem that compromise effective decontamination of the device.	IMDRF:A18
C54451	CDRH Medical Device Problem Code Terminology	C63018	Contamination during Use	Problem associated with the undesired introduction of impurities either chemical or microbiological in nature, or of foreign matter into or onto a device at the user facility.	Contamination	1120	Problem associated with the undesired introduction of impurities either chemical or microbiological in nature, or of foreign matter into or onto the device.	IMDRF:A1801
C54451	CDRH Medical Device Problem Code Terminology	C63293	Biofilm Coating in Device	Problem associated with the undesired introduction of a biofilm coating into or onto the device.	Biofilm coating in Device	1062	Problem associated with the undesired introduction of a biofilm coating into or onto the device.	IMDRF:A180101
C54451	CDRH Medical Device Problem Code Terminology	C63266	Contamination of Device Ingredient or Reagent	Problem associated with the undesired introduction of impurities either chemical or microbiological in nature, or of foreign matter into or onto the device ingredient or reagent.	Contamination of Device Ingredient or Reagent	2901	Problem associated with the undesired introduction of impurities either chemical or microbiological in nature, or of foreign matter into or onto the device ingredient or reagent.	IMDRF:A180102
C54451	CDRH Medical Device Problem Code Terminology	C63016	Device Contamination with Body Fluid	Problem associated with the undesired presence of body fluid in/on the device, which are not part of the documented device specifications and requirements.	Device Contamination with Body Fluid	2317	Problem associated with the undesired presence of body fluid in/on the device, which are not part of the documented device specifications and requirements.	IMDRF:A180103
C54451	CDRH Medical Device Problem Code Terminology	C63133	Device Contamination with Chemical or Other Material	Problem associated with contamination of a device with a chemical substance or other non biologic material.	Device Contamination with Chemical or Other Material	2944	Problem associated with contamination of the device with chemical substance or other non biologic material.	IMDRF:A180104
C54451	CDRH Medical Device Problem Code Terminology	C63297	Bacterial Contamination of Device	Problem associated with undesired microbial contamination of the device.	Microbial Contamination of Device	2303	Problem associated with undesired microbial contamination of the device.	IMDRF:A180105
C54451	CDRH Medical Device Problem Code Terminology	C63019	Device Contaminated during Manufacturing or Shipping	Problem associated with the presence of any unexpected foreign substance found on the surface or in the package materials, which may affect optimal performance for its intended use.	Device Contaminated During Manufacture or Shipping	2969	Problem associated with the presence of any unexpected foreign substance found on the surface or in the package materials, which may affect optimal performance for its intended use, and which occurred during manufacture or shipping.	IMDRF:A1802
C54451	CDRH Medical Device Problem Code Terminology	C63099	Device Reprocessing Problem	Problem associated with a failure during any step of reprocessing process (cleaning, disinfection, packaging, labeling, sterilization) of a used or opened from its original packaging, but unused, device.	Device Reprocessing Problem	1091	Problem associated with a failure during any step of reprocessing process (cleaning, disinfection, packaging, labeling, sterilization) of a used or opened from its original packaging, but unused, device.	IMDRF:A1803
C54451	CDRH Medical Device Problem Code Terminology	C133637	Failure to Adequately Clean	Problem associated with the failure of the device or operator to remove any visible soil, foreign material or organism deposits on the external surfaces, crevices, and joints of the device.	Failure to Clean Adequately	4048	Problem associated with the failure of the device or operator to remove any visible soil, foreign material or organism deposits on the external surfaces, crevices, and joints of the device.	IMDRF:A180301
C54451	CDRH Medical Device Problem Code Terminology	C63179	Failure to Disinfect	Failure to properly disinfect the device during reprocessing.	Failure to Disinfect	1175	Failure to properly disinfect the device when reprocessing it.	IMDRF:A180302
C54451	CDRH Medical Device Problem Code Terminology	C63176	Flushing Problem	Flushing process was not executed properly.	Flushing Problem	1252	Flushing process was not executed properly.	IMDRF:A180303
C54451	CDRH Medical Device Problem Code Terminology	C63163	Problem with Removal of Enzymatic Cleaner	Enzymatic cleaner was not removed properly from the device.	Problem with Removal of Enzymatic Cleaner	1213	Enzymatic cleaner was not removed properly.	IMDRF:A180304
C54451	CDRH Medical Device Problem Code Terminology	C63156	Problem with Sterilization	Device was not sterilized properly during reprocessing.	Problem with Sterilization	1596	Device was not sterilized properly during reprocessing.	IMDRF:A180305
C54451	CDRH Medical Device Problem Code Terminology	C62850	Residue after Decontamination	Problem associated with the decontamination process not adequately removing unwanted visible soil, foreign material, or organism deposits.	Residue After Decontamination	2325	Problem associated with the decontamination process not adequately removing unwanted visible soil, foreign material, or organism deposits.	IMDRF:A180306
C54451	CDRH Medical Device Problem Code Terminology	C172085	Device Contaminated at the User Facility	Problem associated with the presence of any unexpected foreign substance found on the surface or in the package materials, which may affect optimal performance for its intended use, and which occurred at the user facility.	Device Contaminated at the User Facility	4064	Problem associated with the presence of any unexpected foreign substance found on the surface or in the package materials, which may affect optimal performance for its intended use, and which occurred at the user facility.	IMDRF:A1804
C54451	CDRH Medical Device Problem Code Terminology	C63209	Environmental  Compatibility Problem	Problem associated with the surrounding conditions in which the device is being used such as temperature, noise, lighting, ventilation, or other external factors such as power supply.	Environmental Compatibility Problem	2929	Problem associated with the surrounding conditions in which the device is being used such as temperature, noise, lighting, ventilation, or other external factors such as power supply.	IMDRF:A19
C54451	CDRH Medical Device Problem Code Terminology	C63308	Device Ambient Noise Problem	Problem associated with any undesired acoustic energy or vibration that tends to interfere with the operation of the device.	Ambient Noise Problem	2877	Problem associated with any undesired acoustic energy or vibration that tends to interfere with the operation of the device.	IMDRF:A1901
C54451	CDRH Medical Device Problem Code Terminology	C63307	Ambient Temperature Problem	Problem associated with compromised device performance at the ambient temperature or the storage at an inappropriate ambient temperature.	Ambient Temperature Problem	2878	Problem associated with compromised device performance at the ambient temperature or the storage at an inappropriate ambient temperature.	IMDRF:A1902
C54451	CDRH Medical Device Problem Code Terminology	C63129	Fume or Vapors	Problem associated with the visibility, odor, or toxicity of an ambient vapor or gas.	Fumes or Vapors	2529	Problem associated with the visibility, odor, or toxicity of an ambient vapor or gas.	IMDRF:A1903
C54451	CDRH Medical Device Problem Code Terminology	C63128	Fungus in Device Environment	Problem associated with the visibility of molds, mildews, yeasts, and/or mushrooms in the immediate environment in which the device is being used.	Fungus in Device Environment	2316	Problem associated with the visibility of molds, mildews, yeasts, and/or mushrooms in the immediate environment in which the device is being used.	IMDRF:A1904
C54451	CDRH Medical Device Problem Code Terminology	C62909	Moisture or Humidity Problem	Problem associated with an unsatisfactory humidity level in the storage or use environment which affects the device performance.	Moisture or Humidity Problem	2986	Problem associated with an unsatisfactory humidity level in the storage or use environment which affects the device performance.	IMDRF:A1905
C54451	CDRH Medical Device Problem Code Terminology	C62910	Moisture Damage	Problem associated with damage inflicted upon the device from water vapor or water in the immediate environment in which the device is being used.	Moisture Damage	1405	Problem associated with damage inflicted upon the device from water vapor or water in the immediate environment in which the device is being used.	IMDRF:A190501
C54451	CDRH Medical Device Problem Code Terminology	C62807	Ventilation Problem in Device Environment	Problem associated with the circulation of fresh air in the immediate atmosphere in which the device is being used.	Ventilation Problem in Device Environment	3027	Problem associated with the circulation of fresh air in the immediate atmosphere in which the device is being used.	IMDRF:A1906
C54451	CDRH Medical Device Problem Code Terminology	C63135	Fogging	Problem associated with the visibility of water vapor in the immediate atmosphere in which the device is being used.	Fogging	1253	Problem associated with the visibility of water vapor in the immediate atmosphere in which the device is being used.	IMDRF:A190601
C54451	CDRH Medical Device Problem Code Terminology	C73118	Device Unsafe to Use in Environment	Problem associated with environmental condition that results in the unsafe use of the device. (e.g. electromagnetic fields, noise, vibration, microbiological contamination etc.).	Device Unsafe to Use in Environment	2918	Problem associated with environmental condition that results in the unsafe use of the device. (e.g. electromagnetic fields, noise, vibration, microbiological contamination etc.)	IMDRF:A1907
C54451	CDRH Medical Device Problem Code Terminology	C72674	Environmental Particulates	Problem associated with fine solids or liquid particles such as dust, smoke, fume, and/or mist suspended in the immediate atmosphere in which the device is being used.	Environmental Particulates	2930	Problem associated with fine solids or liquid particles such as dust, smoke, fume, and/or mist suspended in the immediate atmosphere in which the device is being used.	IMDRF:A1908
C54451	CDRH Medical Device Problem Code Terminology	C72887	Medical Gas Supply Problem	Problem associated with the facility-supplied medical gases such as medical air, oxygen, nitrous oxide, and nitrogen.	Medical Gas Supply Problem	2985	Problem associated with the facility-supplied medical gases such as medical air, oxygen, nitrous oxide, and nitrogen.	IMDRF:A1909
C54451	CDRH Medical Device Problem Code Terminology	C63217	Electrical Power Problem	Problem associated with the quality of the facility-supplied power to the device.	Electrical Power Problem	2925	Problem associated with the quality of the facility-supplied power.	IMDRF:A1910
C54451	CDRH Medical Device Problem Code Terminology	C63212	Emergency Power Failure	Problem associated with the failure of the facility's emergency power backup system(s) including generators and/or interruptible power systems (UPS).	Emergency Power Failure	1205	Problem associated with the failure of the facility's emergency power backup system(s) including generators and/or interruptible power systems (UPS).	IMDRF:A191001
C54451	CDRH Medical Device Problem Code Terminology	C63052	Loss of Power Problem	Problem associated with the failure of primary power supplied by the facility.	Loss of Power	1475	Problem associated with the failure of primary power supplied by the facility.	IMDRF:A191002
C54451	CDRH Medical Device Problem Code Terminology	C62868	Power Conditioning Issue	Problem associated with a momentary overpower/over voltage from the utility and electrical systems of user facilities; or inadequate power conditioning such as the presence of fluctuation, surges, spikes, dropouts, noise and other such undesirable transients.	Power Conditioning Problem	1474	Problem associated with a momentary overpower/over voltage from the utility and electrical systems of user facilities; - Problem associated with inadequate power conditioning such as the presence of fluctuation, surges, spikes, dropouts, noise and other such undesirable transients.	IMDRF:A191003
C54451	CDRH Medical Device Problem Code Terminology	C63074	Installation-Related Problem	Problem associated with unsatisfactory installation, configuration, and/or setup of a specific device.	Installation-Related Problem	2965	Problem associated with unsatisfactory installation, configuration, and/or setup of a specific device.	IMDRF:A20
C54451	CDRH Medical Device Problem Code Terminology	C133721	Misassembled During Installation	Problem associated with the use of the device characterized by incorrect assembly of device components, parts or constituents.	Misassembled During Installation	4049	Problem associated with the use of the device characterized by incorrect assembly of device components, parts or constituents.	IMDRF:A2001
C54451	CDRH Medical Device Problem Code Terminology	C63072	Labeling, Instructions for Use or Training Problem	Problem associated with device markings/labeling, instructions for use, training and maintenance documentation or guidelines.	Labelling, Instructions for Use or Training Problem	1318	Problem associated with device markings/labelling, instructions for use, training and maintenance documentation or guidelines.	IMDRF:A21
C54451	CDRH Medical Device Problem Code Terminology	C62976	Device Markings/Labeling Problem	Problem associated with the written, printed or graphic material accompanying or affixed to the device or any of its packaging. This includes verbal instructions relating to identification, technical description, and usage provided by a medical device manufacturers. Problems can include but are not limited to this material being unclear, missing, worn out, incorrect or inaccurate.	Device Markings/Labelling Problem	2911	Problem associated with the written, printed or graphic material accompanying or affixed to the device or any of its packaging. This includes verbal instructions relating to identification, technical description, and usage provided by the device manufacturers. Problems can include but are not limited to this material being unclear, missing, worn out, incorrect or inaccurate.	IMDRF:A2101
C54451	CDRH Medical Device Problem Code Terminology	C62999	Expiration Date Error	Problem associated with errors in identification of expiration date.	Expiration Date Error	2528	Problem associated with errors in identification of expiration date.	IMDRF:A210101
C54451	CDRH Medical Device Problem Code Terminology	C133642	Illegible Information	Problem associated with information unable to be read or deciphered.	Illegible Information	4050	Problem associated with information unable to be read or deciphered.	IMDRF:A210102
C54451	CDRH Medical Device Problem Code Terminology	C133643	Inaccurate Information	Problem associated with imprecise, inexact information.	Inaccurate Information	4051	Problem associated with imprecise, inexact information.	IMDRF:A210103
C54451	CDRH Medical Device Problem Code Terminology	C133644	Unclear Information	Problem associated with ambiguous, confusing information.	Unclear Information	4052	Problem associated with ambiguous, confused information.	IMDRF:A210104
C54451	CDRH Medical Device Problem Code Terminology	C133645	Missing Information	Absence of information e.g. labeling, instruction for use.	Missing Information	4053	Absence of information e.g. labeling, instruction for use.	IMDRF:A210105
C54451	CDRH Medical Device Problem Code Terminology	C187259	Wrong Label	Problem associated with an incorrect label being affixed to the device or packaging.	Wrong Label	4073	Problem associated with an incorrect label being affixed to the device or packaging.	IMDRF:A210106
C54451	CDRH Medical Device Problem Code Terminology	C72671	Lack of Maintenance Documentation or Guidelines	Problem associated with user facility not receiving adequate service documentation, guidelines, or recommendations to perform preventative and corrective maintenance and performance assurance checks.	Lack of Maintenance Documentation or Guidelines	2971	Problem associated with user facility not receiving adequate service documentation, guidelines, or recommendations to perform preventative and corrective maintenance and performance assurance checks.	IMDRF:A2102
C54451	CDRH Medical Device Problem Code Terminology	C63087	Inadequate Instructions for Healthcare Professional	Problem associated with inaccuracies in any written, printed, or graphic matter that is affixed to the device or its packaging with any matter that accompanies the device including verbal instructions related to identification, technical description and use of the device provided by the device manufacturers that is intended for healthcare professionals.	Inadequate Instructions for Healthcare Professional	1319	Problem associated with inaccuracies in any written, printed, or graphic matter that is affixed to the device or its packaging with any matter that accompanies the device including verbal instructions related to identification, technical description and use of device provided by the device manufacturers that is intended for healthcare professionals.	IMDRF:A2103
C54451	CDRH Medical Device Problem Code Terminology	C63267	Inadequate Instructions for Non-Healthcare Professional	Problem associated with users being unclear and not able to follow any written, printed, or graphic matter that is affixed to device or its packaging with any matter that accompanies a medical device including verbal instructions related to identification, technical description and use of the device provided by a medical device manufacturer that vary from the standard of medical care in a given environment.	Inadequate Instructions for Non-Healthcare Professional	2956	Problem associated with users being unclear and not able to follow any written, printed, or graphic matter that is affixed to device or its packaging with any matter that accompanies the device including verbal instructions related to identification, technical description and use of the device provided by the device manufactures that vary from the standard of medical care in a given environment.	IMDRF:A2104
C54451	CDRH Medical Device Problem Code Terminology	C73117	Inadequate Device Operator Training	Problem associated with facility not providing satisfactory initial and/or periodic user training covering operation of a medical device.	Inadequate or Insufficient Training	1643	Problem associated with facility not providing satisfactory initial and/or periodic user training covering operation of the device.	IMDRF:A2105
C54451	CDRH Medical Device Problem Code Terminology	C76121	Human-Device Interface Issue	Problem associated with an act or omission of an act that has a different result than that intended by the manufacturer or expected by the operator.	Human-Device Interface Problem	2949	Problem associated with an act or omission of an act that has a different result than that intended by the manufacturer or expected by the operator.	IMDRF:A22
C54451	CDRH Medical Device Problem Code Terminology	C63010	Device Difficult to Prepare	Problem associated with the use of the device in terms of user experiencing difficulty in preparing device for use, even if the operation is being performed according to labeled instructions for use.	Device Difficult to Setup or Prepare	1487	Problem associated with the use of the device in terms of user experiencing difficulty in preparing device for use, even if the operation is being performed according to labeled instructions for use.	IMDRF:A2201
C54451	CDRH Medical Device Problem Code Terminology	C64339	Difficult to Program or Calibrate	The device that is difficult to program, calibrate or set to desired state, even by appropriately trained user/operator.	Device Difficult to Program or Calibrate	1496	The device is difficult to program, calibrate or set to desired state, even by appropriately trained user/operator.	IMDRF:A2202
C54451	CDRH Medical Device Problem Code Terminology	C79146	Device Difficult to Maintain	Problem associated with the user's ability to service a medical device according to the manufacturer specifications relating to a routine device maintenance, i.e., periodic inspection, failure detection, repair, and care of the device to sustain or restore acceptable operating conditions.	Device Difficult to Maintain	3134	Problem associated with the user's ability to service the device according to the manufacturer specifications relating to the device routine maintenance, i.e., periodic inspection, failure detection, repair, and care of the device to sustain or restore acceptable operating conditions.	IMDRF:A2203
C54451	CDRH Medical Device Problem Code Terminology	C63100	Inadequate User Interface	Problem associated with the means by which the operator and the equipment communicate or interact.	Inadequate User Interface	2958	Problem associated with the means by which the operator and the equipment communicate or interact.	IMDRF:A2204
C54451	CDRH Medical Device Problem Code Terminology	C63318	Use of Device Problem	Problem associated with failure to process, service, or operate the device according to the manufacturer's recommendations or recognized best practices.	Use of Device Problem	1670	Problem associated with failure to process, service, or operate the device according to the manufacturer's recommendations or recognized best practices.	IMDRF:A23
C54451	CDRH Medical Device Problem Code Terminology	C95879	Device Handling Problem	Handling of the device not in accordance with specification, prior to use on the patient.	Device Handling Problem	3265	Handling of the device not in accordance with specification, prior to use on the patient.	IMDRF:A2301
C54451	CDRH Medical Device Problem Code Terminology	C63264	Use of Incorrect Control/Treatment Settings	Problem associated with the use of the device in terms of inappropriate or incorrect control settings or incorrect treatment parameters for the device's specified operation and/or intended use.	Use of Incorrect Control Settings	1126	Problem associated with the use of the device in terms of inappropriate or incorrect control settings or incorrect treatment parameters for the device's specified operation and/or intended use.	IMDRF:A2302
C54451	CDRH Medical Device Problem Code Terminology	C62862	Improper or Incorrect Procedure or Method	Problem associated with the use of the device in terms of nonconforming to that device's intended use, specifications, procedure and process or service instructions and information provided by the device manufacturers.	Improper or Incorrect Procedure or Method	2017	Problem associated with the use of the device in terms of nonconforming to that device's intended use, specifications, procedure and process or service instructions and information provided by the device manufacturers.	IMDRF:A2303
C54451	CDRH Medical Device Problem Code Terminology	C63082	Off-Label Use	Problem associated with the device which has been used for an unapproved indication or for an unapproved intended use.	Off-Label Use	1494	Problem associated with the device which has been used for an unapproved indication or for an unapproved intended use.	IMDRF:A2304
C54451	CDRH Medical Device Problem Code Terminology	C62958	Misassembled Device	Problem associated with incorrect assembly of the device or constituents after being put into use.	Misassembled	1398	Problem associated with incorrect assembly of the device or constituents after being put into use.	IMDRF:A2305
C54451	CDRH Medical Device Problem Code Terminology	C79147	Misassembled by Users	Problem associated with incorrect assembly of a medical device or constituents by the users.	Misassembly by Users	3133	Problem associated with incorrect assembly of the device or constituents by the users.	IMDRF:A230501
C54451	CDRH Medical Device Problem Code Terminology	C133646	Misassembly during Maintenance/Repair	Problem associated with incorrect assembly of the device or constituents during maintenance or repair.	Misassembly During Maintenance/Repair	4054	Problem associated with incorrect assembly of the device or constituents during maintenance or repair.	IMDRF:A230502
C54451	CDRH Medical Device Problem Code Terminology	C76126	Adverse Event without Identified Device or Use Problem	An adverse event appears to have occurred, but there does not appear to have been a problem with a medical device or the way it was used.	Adverse Event Without Identified Device or Use Problem	2993	An adverse event (e.g. patient harm) appears to have occurred, but there does not appear to have been a problem with the device or the way it was used.	IMDRF:A24
C54451	CDRH Medical Device Problem Code Terminology	C48660	Not Applicable	Determination of a value is not relevant in the current context.	No Apparent Adverse Event	3189	A report has been received but the description provided does not appear to relate to an adverse event. This code allows a report to be recorded for administration purposes, even if it doesn't meet the requirements for adverse event reporting. || Determination of a value is not relevant in the current context. || If a value for test has to be provided, but has no given criteria (e.g., the result is for "report only" or "monitoring").	IMDRF:A25
C54451	CDRH Medical Device Problem Code Terminology	C172136	Insufficient Adverse Event Information Available	Not yet enough information available to classify the device problem from the adverse event.	Insufficient Information	3190	An adverse event appears to have occurred but there is not yet enough information available to classify the device problem.	IMDRF:A26
C54451	CDRH Medical Device Problem Code Terminology	C64343	Appropriate Term/Code Not Available Problem Code	A device problem is not adequately described by any other term. Note: this code must not be used unless there is no other feasible code.	Appropriate Term/Code Not Available	3191	The device problem is not adequately described by any other term. Note: this code must not be used unless there is no other feasible code. The preferred term should be documented when submitting an adverse event report. This information will be used to determine if a new term should be added to the code table.	IMDRF:A27
C91800	CDRH Cause Investigation - Type of Investigation Terminology	C91896	Testing of Actual/Suspected Device	The investigation employed relevant empirical testing of the actual device suspected in the reported adverse event in order to establish their functional and other properties and to identify possible causes for the adverse event. Relevant testing would typically be based on test methods used for evaluating safety and performance as described in the latest relevant standards.	Testing of Actual/Suspected Device	10	The investigation employed relevant empirical testing of the actual device suspected in the reported adverse event in order to establish their functional and other properties and to identify possible causes for the adverse event. Relevant testing would typically be based on test methods used for evaluating safety and performance as described in the latest relevant standards.	IMDRF:B01
C91800	CDRH Cause Investigation - Type of Investigation Terminology	C91933	Device from Same Lot Evaluated Evaluation Method	The investigation employed relevant empirical testing of the device of the same lot or batch than that of the suspected device in the reported adverse event in order to support the identification of possible causes for the adverse event. Testing was performed using the device retained by the manufacturer (i.e. was not shipped). Relevant testing would typically be based on test methods used for evaluating safety and performance as described in the latest relevant standards.	Testing of Device from Same Lot/Batch Retained by Manufacturer	11	The investigation employed relevant empirical testing of the device of the same lot or batch than that of the suspected device in the reported adverse event in order to support the identification of possible causes for the adverse event. Testing was performed using the device retained by the manufacturer (i.e. was not shipped). Relevant testing would typically be based on test methods used for evaluating safety and performance as described in the latest relevant standards.	IMDRF:B02
C91800	CDRH Cause Investigation - Type of Investigation Terminology	C139447	Testing of Device from Same Lot/Batch Returned from User	The investigation employed relevant empirical testing of the device of the same lot or batch than that of the suspected device in the reported adverse event in order to support the identification of possible causes for the adverse event. The device was returned from the user. Relevant testing would typically be based on test methods used for evaluating safety and performance as described in the latest relevant standards.	Testing of Device from Same Lot/Batch Returned from User	4101	The investigation employed relevant empirical testing of the device of the same lot or batch than that of the suspected device in the reported adverse event in order to support the identification of possible causes for the adverse event. The device was returned from the user. Relevant testing would typically be based on test methods used for evaluating safety and performance as described in the latest relevant standards.	IMDRF:B03
C91800	CDRH Cause Investigation - Type of Investigation Terminology	C139448	Testing of Device from Other Lot/Batch Retained by Manufacturer	The investigation employed relevant empirical testing of the device of another lot or batch than that of the suspected device in the reported adverse event in order to support the identification of possible causes for the adverse event. This includes devices without a lot/batch designation. Testing was performed using the device retained by the manufacturer (i.e. was not shipped). Relevant testing would typically be based on test methods used for evaluating safety and performance as described in the latest relevant standards.	Testing of Device from Other Lot/Batch Retained by Manufacturer	4102	The investigation employed relevant empirical testing of the device of another lot or batch than that of the suspected device in the reported adverse event in order to support the identification of possible causes for the adverse event. This includes devices without a lot/batch designation. Testing was performed using the device retained by the manufacturer (i.e. was not shipped). Relevant testing would typically be based on test methods used for evaluating safety and performance as described in the latest relevant standards.	IMDRF:B04
C91800	CDRH Cause Investigation - Type of Investigation Terminology	C139449	Testing of Device from Other Lot/Batch Returned from User	The investigation employed relevant empirical testing of the device of another lot or batch than that of the suspected device in the reported adverse event in order to support the identification of possible causes for the adverse event. This includes devices without a lot/batch designation. The device was returned from the user. Relevant testing would typically be based on test methods used for evaluating safety and performance as described in the technical file. Relevant testing would typically be based on test methods used for evaluating safety and performance as described in the latest relevant standards.	Testing of Device from Other Lot/Batch Returned From User	4103	The investigation employed relevant empirical testing of the device of another lot or batch than that of the suspected device in the reported adverse event in order to support the identification of possible causes for the adverse event. This includes devices without a lot/batch designation. The device was returned from the user. Relevant testing would typically be based on test methods used for evaluating safety and performance as described in the technical file or in the latest relevant standards.	IMDRF:B05
C91800	CDRH Cause Investigation - Type of Investigation Terminology	C139450	Testing of Model Variant	The investigation employed relevant empirical testing of a model variant of the device involved in the reported adverse event in order to support the identification of possible causes for the adverse event through plausibility reasoning. A model variant is not identical to the actual device, but shares relevant characteristics with the device involved. Relevant testing would typically be based on test methods used for evaluating safety and performance as described in the latest relevant standards.	Testing of Model Variant	4104	The investigation employed relevant empirical testing of a model variant of the device involved in the reported adverse event in order to support the identification of possible causes for the adverse event through plausibility reasoning. A model variant is not identical to the actual device, but shares relevant characteristics with the device involved. Relevant testing would typically be based on test methods used for evaluating safety and performance as described in the latest relevant standards.	IMDRF:B06
C91800	CDRH Cause Investigation - Type of Investigation Terminology	C139451	Testing of Raw/Starting Materials	The investigation employed relevant empirical testing of the materials used in construction of the device involved in the reported adverse event in order to support the identification of possible causes for the adverse event. Relevant testing would typically be based on test methods used for evaluating safety and performance as described in the latest relevant standards.	Testing of Raw/Starting Materials	4105	The investigation employed relevant empirical testing of the materials used in construction of the device involved in the reported adverse event in order to support the identification of possible causes for the adverse event. Relevant testing would typically be based on test methods used for evaluating safety and performance as described in the latest relevant standards.	IMDRF:B07
C91800	CDRH Cause Investigation - Type of Investigation Terminology	C139452	Testing of Patient Sample or Reference Material Using Manufacturer's Device	The investigation employed relevant empirical testing of a patient sample or reference material using the device (usually an IVD) involved in the reported adverse event in order to support the identification of possible causes for the adverse event. Relevant testing would typically be based on test methods used for evaluating safety and performance as described in the latest relevant standards.	Testing of Patient Sample or Reference Material Using Manufacturer's Device	4106	The investigation employed relevant empirical testing of a patient sample or reference material using the device (usually an IVD) involved in the reported adverse event in order to support the identification of possible causes for the adverse event. Relevant testing would typically be based on test methods used for evaluating safety and performance as described in the latest relevant standards.	IMDRF:B08
C91800	CDRH Cause Investigation - Type of Investigation Terminology	C139453	Testing of Patient Sample or Reference Material Using Reference Method	The investigation employed relevant empirical testing of a patient sample or reference material using an appropriate reference method to the device (usually an IVD) involved in the reported adverse event in order to support the identification of possible causes for the adverse event. Relevant testing would typically be based on test methods used for evaluating safety and performance as described in the latest relevant standards.	Testing of Patient Sample or Reference Material Using Reference Method	4107	The investigation employed relevant empirical testing of a patient sample or reference material using an appropriate reference method to the device (usually an IVD) involved in the reported adverse event in order to support the identification of possible causes for the adverse event. Relevant testing would typically be based on test methods used for evaluating safety and performance as described in the latest relevant standards.	IMDRF:B09
C91800	CDRH Cause Investigation - Type of Investigation Terminology	C139454	Testing of Patient Sample or Reference Material Using Competitor's Device	The investigation employed relevant empirical testing of a patient sample or reference material using a competitor's device that is comparable to the device (usually an IVD) involved in the reported adverse event in order to support the identification of possible causes for the adverse event. Relevant testing would typically be based on test methods used for evaluating safety and performance as described in the latest relevant standards.	Testing of Patient Sample or Reference Material Using Competitor's Device	4108	The investigation employed relevant empirical testing of a patient sample or reference material using a competitor's device that is comparable to the device (usually an IVD) involved in the reported adverse event in order to support the identification of possible causes for the adverse event. Relevant testing would typically be based on test methods used for evaluating safety and performance as described in the latest relevant standards.	IMDRF:B10
C91800	CDRH Cause Investigation - Type of Investigation Terminology	C139455	Historical Data Analysis	The investigation involved the analysis of historical adverse events data of the actual device involved in the adverse event and/or of products from the same and/or different batches/lots.	Historical Data Analysis	4109	The investigation involved the analysis of historical adverse events data of the actual device involved in the adverse event and/or of products from the same and/or different batches/lots.	IMDRF:B11
C91800	CDRH Cause Investigation - Type of Investigation Terminology	C139456	Trend Analysis	The investigation involved trend analysis of adverse event of the actual device involved in the adverse event and/or of products from the same and/or different batches/lots. It should be noted that trend analysis typically is not considered sufficient as a stand-alone method, but should be used in conjunction with other investigation methods for providing for instance complementary information.	Trend Analysis	4110	The investigation involved trend analysis of adverse event of the actual device involved in the adverse event and/or of products from the same and/or different batches/lots. It should be noted that trend analysis typically is not considered sufficient as a stand-alone method, but should be used in conjunction with other investigation methods for providing for instance complementary information.	IMDRF:B12
C91800	CDRH Cause Investigation - Type of Investigation Terminology	C139457	Communication/Interviews	The investigation involved communication/interviews (either interpersonal or through technical means, e.g. phone, e-mail) with persons close to the adverse event, e.g. healthcare professionals (doctors, nurses etc.), the affected patient(s) or other users including, where appropriate, relatives or others engaged in caring for the affected patient.	Communication/Interviews	4111	The investigation involved communication/interviews (either interpersonal or through technical means, e.g. phone, e-mail) with persons close to the adverse event, e.g. healthcare professionals (doctors, nurses etc.), the affected patient(s) or other users including, where appropriate, relatives or others engaged in caring for the affected patient.	IMDRF:B13
C91800	CDRH Cause Investigation - Type of Investigation Terminology	C91978	Analysis of Production Records	The investigation involved the analysis of relevant production records in view of supporting the identification of possible causes for the adverse event.	Analysis of Production Records	3331	The investigation involved the analysis of relevant production records in view of supporting the identification of possible causes for the adverse event.	IMDRF:B14
C91800	CDRH Cause Investigation - Type of Investigation Terminology	C139458	Analysis of Data Provided by User/Third Party	The investigation involved the analysis of relevant data provided by the user (e.g. healthcare professional, patient, clinical engineer) or a third party (e.g. testing facility) in view of supporting the identification of possible causes for the adverse event.	Analysis of Data Provided by User/Third Party	4112	The investigation involved the analysis of relevant data provided by the user (e.g. healthcare professional, patient, clinical engineer) or a third party (e.g. testing facility) in view of supporting the identification of possible causes for the adverse event.	IMDRF:B15
C91800	CDRH Cause Investigation - Type of Investigation Terminology	C139459	Device Not Manufactured by Reporting Manufacturer	Further information was obtained which established that the manufacturer of the device involved was not the one to which it was initially attributed.	Device Not Manufactured by Reporting Manufacturer	4113	Further information was obtained which established that the manufacturer of the device involved was not the one to which it was initially attributed. Use in conjunction with C20 and D14.	IMDRF:B16
C91800	CDRH Cause Investigation - Type of Investigation Terminology	C139460	Device Not Returned	The actual device involved in the adverse event was not returned for testing despite requests by manufacturer.	Device Not Returned	4114	The actual device involved in the adverse event was not returned for testing despite requests by manufacturer.	IMDRF:B17
C91800	CDRH Cause Investigation - Type of Investigation Terminology	C139461	Device Discarded	The actual device involved in the adverse event had been already discarded and thus irretrievably lost for testing.	Device Discarded	4115	The actual device involved in the adverse event had been already discarded and thus irretrievably lost for testing.	IMDRF:B18
C91800	CDRH Cause Investigation - Type of Investigation Terminology	C139462	Incomplete Device Returned	The device was returned incompletely, lacking parts, components or accessories that would be required for appropriate testing and analysis of root causes.	Incomplete Device Returned	4116	The device was returned incompletely, lacking parts, components or accessories that would be required for appropriate testing and analysis of root causes.	IMDRF:B19
C91800	CDRH Cause Investigation - Type of Investigation Terminology	C139463	Device Not Accessible for Testing	The actual device involved in the adverse event is not readily accessible for testing (e.g. remains implanted in patient).	Device Not Accessible for Testing	4117	The actual device involved in the adverse event is not readily accessible for testing (e.g. remains implanted in patient).	IMDRF:B20
C91800	CDRH Cause Investigation - Type of Investigation Terminology	C139464	Type of Investigation Not Yet Determined	Details to determine the type of investigation are not yet available, but are being sought. Do not use this code if the investigation is complete.	Type of Investigation Not Yet Determined	4118	Details to determine the type of investigation are not yet available, but are being sought. Do not use this code if the investigation is complete.	IMDRF:B21
C91800	CDRH Cause Investigation - Type of Investigation Terminology	C139465	Insufficient Information Available	The information available relating to the reported event is not sufficient to identify either the manufacturer, the device, or other essential information.	Insufficient Information Available	4119	The information available relating to the reported event is not sufficient to identify either the manufacturer, the device, or other essential information. This term indicates that no further investigation is possible. Do not use this code if further information is being sought, instead use ''Type of investigation not yet determined''.	IMDRF:B22
C91800	CDRH Cause Investigation - Type of Investigation Terminology	C177428	Specimen Requested But Not Provided	A patient specimen was required to adequately investigate the issue and was requested but not provided.	Specimen Requested But Not Provided	4120	A patient specimen was required to adequately investigate the issue and was requested but not provided.	IMDRF:B23
C91800	CDRH Cause Investigation - Type of Investigation Terminology	C187262	Event History Log Review	The investigation involved the analysis of the history log files retrieved from the device to support possible causes for the adverse event.	Event History Log Review	4121	The investigation involved the analysis of the history log files retrieved from the device to support possible causes for the adverse event.	IMDRF:B24
C91801	CDRH Cause Investigation - Investigation Findings Terminology	C92030	Biological Problem Identified	Problems relating to, caused by or affecting biological processes or living organisms.	Biological Problem Identified	3204	Problems relating to, caused by or affecting biological processes or living organisms.	IMDRF:C01
C91801	CDRH Cause Investigation - Investigation Findings Terminology	C92029	Biocompatibility Problem Identified	The device causes cellular or tissue responses that elicit an undesirable local or systemic effect in the recipient or beneficiary of that therapy. (See ISO 10993)	Biocompatibility Problem Identified	3203	The device causes cellular or tissue responses that elicit an undesirable local or systemic effect in the recipient or beneficiary of that therapy. (See ISO 10993)	IMDRF:C0101
C91801	CDRH Cause Investigation - Investigation Findings Terminology	C92054	Biological Contamination	The undesirable presence of living organisms such as bacteria, fungi, or viruses or their products (enzymes or toxins).	Biological Contamination	142	The undesirable presence of living organisms such as bacteria, fungi, or viruses or their products (enzymes or toxins).	IMDRF:C0102
C91801	CDRH Cause Investigation - Investigation Findings Terminology	C92049	Endotoxin Contamination	The undesirable presence of toxins associated with certain bacteria (e.g. gram negative bacteria).	Endotoxin Contamination	3212	The undesirable presence of toxins associated with certain bacteria (e.g. gram negative bacteria).	IMDRF:C010201
C91801	CDRH Cause Investigation - Investigation Findings Terminology	C92081	Microbial Contamination	The undesirable presence of microorganisms or microbes such as bacteria and fungi (yeasts and molds).	Microbial Contamination	3218	The undesirable presence of microorganisms or microbes such as bacteria and fungi (yeasts and molds).	IMDRF:C010202
C91801	CDRH Cause Investigation - Investigation Findings Terminology	C92077	Material or Material Leachate Pyrogenic Problem	The undesirable presence of pyrogens or fever-producing organisms caused by materials that permeate through the device.	Material or Material Leachate Pyrogenic Problem	3216	The undesirable presence of pyrogens or fever-producing organisms caused by materials that permeate through the device.	IMDRF:C0103
C91801	CDRH Cause Investigation - Investigation Findings Terminology	C139483	Cytotoxicity Problem Identified	The device was found to have an undesirable level of toxicity to living cells.	Cytotoxicity Problem Identified	4201	The device was found to have an undesirable level of toxicity to living cells.	IMDRF:C0104
C91801	CDRH Cause Investigation - Investigation Findings Terminology	C92057	Device Genotoxicity Problem Identified	The device's ability to cause damage to genetic material (e.g. leading to malignant tumors).	Genotoxicity Problem Identified	3254	The device's ability to cause damage to genetic material (e.g. leading to malignant tumors). (See ISO 10993)	IMDRF:C0105
C91801	CDRH Cause Investigation - Investigation Findings Terminology	C92031	Device Carcinogenic Problem	The device's ability to trigger development of cancer.	Carcinogenic Problem	3205	The device's ability to trigger development of cancer.	IMDRF:C010501
C91801	CDRH Cause Investigation - Investigation Findings Terminology	C92082	Mutagenic Problem	The device's ability to change genetic information (usually DNA) of an organism and thus increasing the frequency of mutations.	Mutagenic Problem	3220	The device's ability to change genetic information (usually DNA) of an organism and thus increasing the frequency of mutations.	IMDRF:C010502
C91801	CDRH Cause Investigation - Investigation Findings Terminology	C92060	Device Hematologic Problem Identified	The device affects or impacts the blood or its components. (See ISO 10993 all parts)	Hematological Problem Identified	3255	The device affects or impacts the blood or its components. (See ISO 10993 all parts)	IMDRF:C0106
C91801	CDRH Cause Investigation - Investigation Findings Terminology	C92026	Device Agglutination Problem	The device affects the ability of the blood to clot which may be induced by chemical, mechanical, or thermal properties of the device.	Agglutination Problem	3202	The device affects the ability of the blood to clot which may be induced by chemical, mechanical, or thermal properties of the device.	IMDRF:C010601
C91801	CDRH Cause Investigation - Investigation Findings Terminology	C92035	Complement Activation Problem	The device affects the body's ability to activate the complement system of the immune system, thereby interfering with the ability to clear pathogens. This may be caused by an interaction of the device with chemicals or materials.	Complement Activation Problem	3206	The device affects the body's ability to activate the complement system of the immune system, thereby interfering with the ability to clear pathogens. This may be caused by an interaction of the device with chemicals or materials.	IMDRF:C010602
C91801	CDRH Cause Investigation - Investigation Findings Terminology	C92095	Platelet Activation Problem	The device affects the body's ability to activate platelet formation.	Platelet Activation Problem	3226	The device affects the body's ability to activate platelet formation.	IMDRF:C010603
C91801	CDRH Cause Investigation - Investigation Findings Terminology	C92123	Problem due to Thrombosis Activation	The device causes the formation of blood clots in or along blood vessels resulting in disturbed or disrupted blood flow.	Problem due to Thrombosis Activation	3244	The device causes the formation of blood clots in or along blood vessels resulting in disturbed or disrupted blood flow.	IMDRF:C010604
C91801	CDRH Cause Investigation - Investigation Findings Terminology	C139484	Unintended Presence of Allergens	Unintended or unexpected presence of allergens in the device.	Unintended Presence of Allergens	4202	Unintended or unexpected presence of allergens in the device. If the presence of the allergen is expected but not adequately labelled, then use "Labelling Problem".	IMDRF:C0107
C91801	CDRH Cause Investigation - Investigation Findings Terminology	C92104	Reproductive Toxicity Problem Identified	The device affects reproductive function, embryo development (teratogenicity), and prenatal and early postnatal development. (ISO 10993 part 3)	Reproductive Toxicity Problem Identified	3232	The device affects reproductive function, embryo development (teratogenicity), and prenatal and early postnatal development. (ISO 10993 part 3)	IMDRF:C0108
C91801	CDRH Cause Investigation - Investigation Findings Terminology	C92045	Electrical Problem Identified	Events associated with an electrically powered device where an electrical malfunction results in a device problem (e.g. electrical circuitry, contact or component failed) even if the problem is intermittent.	Electrical Problem Identified	120	Events associated with an electrically powered device where an electrical malfunction results in a device problem (e.g. electrical circuitry, contact or component failed) even if the problem is intermittent.	IMDRF:C02
C91801	CDRH Cause Investigation - Investigation Findings Terminology	C139489	Electrical/Electronic Component Problem Identified	The performance of an electrical or electronic component was found to be inadequate.	Electrical/Electronic Component Problem Identified	4203	The performance of an electrical or electronic component was found to be inadequate.	IMDRF:C0201
C91801	CDRH Cause Investigation - Investigation Findings Terminology	C92059	Hardware Timing Problem Identified	Problems that results from improper sequential activation of components.	Hardware Timing Problem Identified	211	Problems that results from improper sequential activation of components.	IMDRF:C0202
C91801	CDRH Cause Investigation - Investigation Findings Terminology	C92063	Impedance Problem Identified	Problems due to insufficient or excessive resistance to current flow either by the device or circuit.	Impedance Problem Identified	3257	Problems due to insufficient or excessive resistance to current flow either by the device or circuit.	IMDRF:C0203
C91801	CDRH Cause Investigation - Investigation Findings Terminology	C92068	Insulation Problem Identified	Problems due to inadequate or incorrect electrical insulation material.	Insulation Problem Identified	144	Problems due to inadequate or incorrect electrical insulation material.	IMDRF:C0204
C91801	CDRH Cause Investigation - Investigation Findings Terminology	C92087	Open Circuit	Problem due to an electrical circuit that does not conduct current because a switch is open, a wire is broken, etc.	Open Circuit	122	Problem due to an electrical circuit that does not conduct current because a switch is open, a wire is broken, etc.	IMDRF:C0205
C91801	CDRH Cause Investigation - Investigation Findings Terminology	C92044	Current Leakage Problem	Problems related to leakage currents which may cause electric shock. These currents usually flow through the protective ground conductor. In its absence, these currents could flow from the device to the ground via the human body.	Current Leakage Problem	650	Problems related to leakage currents which may cause electric shock. These currents usually flow through the protective ground conductor. In its absence, these currents could flow from the device to the ground via the human body.	IMDRF:C0206
C91801	CDRH Cause Investigation - Investigation Findings Terminology	C92097	Power Source Problem Identified	Problems related to the source that provides electrical power to the device.	Power Source Problem Identified	3227	Problems related to the source that provides electrical power to the device.	IMDRF:C0207
C91801	CDRH Cause Investigation - Investigation Findings Terminology	C92050	Energy Storage System Problem	Problems related to the energy storage system (e.g. the rechargeable battery, charging system, or capacitor) and includes problems such as premature power source depletion and battery explosions.	Energy Storage System Problem	131	Problems related to the energy storage system (e.g. the rechargeable battery, charging system, or capacitor) and includes problems such as premature power source depletion and battery explosions.	IMDRF:C020701
C91801	CDRH Cause Investigation - Investigation Findings Terminology	C92072	Loss of Power Identified	A device that experienced problems due to a loss in the power supply.	Loss of Power	610	A device that experienced problems due to a loss in the power supply.	IMDRF:C020702
C91801	CDRH Cause Investigation - Investigation Findings Terminology	C92096	Power Fluctuation	The device failed due to fluctuations within the power supply (e.g. transient power, power spike, power dip, or power sequencing).	Power Fluctuation	659	The device failed due to fluctuations within the power supply (e.g. transient power, power spike, power dip, or power sequencing).	IMDRF:C020703
C91801	CDRH Cause Investigation - Investigation Findings Terminology	C92108	Short Circuit	Problems due to an unintentionally low-resistance connection between two points in an electric circuit, resulting in either excessive current flow that often causes damage or in a new shorter circuit that draws current away from the original pathways and components.	Short Circuit	121	Problems due to an unintentionally low-resistance connection between two points in an electric circuit, resulting in either excessive current flow that often causes damage or in a new shorter circuit that draws current away from the original pathways and components.	IMDRF:C0208
C91801	CDRH Cause Investigation - Investigation Findings Terminology	C92109	Signal Loss	Problems due to the loss or weakening of an electrical signal or signals.	Signal Loss	3237	Problems due to the loss or weakening of an electrical signal or signals.	IMDRF:C0209
C91801	CDRH Cause Investigation - Investigation Findings Terminology	C92046	Electromagnetic Compatibility Problem Identified	Device-to-device or device-environment problem resulting from electromagnetic disturbances.	Electromagnetic Compatibility Problem Identified	197	Device-to-device or device-environment problem resulting from electromagnetic disturbances.	IMDRF:C03
C91801	CDRH Cause Investigation - Investigation Findings Terminology	C92037	Conducted Interference	Problems related to electromagnetic interference (EMI) by physical contact with conductors (e.g. wires, resistors, terminals) as opposed to radiated EMI which is caused by induction (without physical contact of the conductors).	Conducted Interference	658	Problems related to electromagnetic interference (EMI) by physical contact with conductors (e.g. wires, resistors, terminals) as opposed to radiated EMI which is caused by induction (without physical contact of the conductors).	IMDRF:C0301
C91801	CDRH Cause Investigation - Investigation Findings Terminology	C92047	Electrostatic Discharge Problem	Problems due to sudden and momentary bursts of electrical current flowing between two objects at different electrical potentials.	Electrostatic Discharge	648	Problems due to sudden and momentary bursts of electrical current flowing between two objects at different electrical potentials.	IMDRF:C0302
C91801	CDRH Cause Investigation - Investigation Findings Terminology	C92135	Inadequate Device Immunity	Problems related to immunity or capabilities to resist electromagnetic interference (EMI).	Inadequate Immunity	3260	Problems related to immunity or capabilities to resist electromagnetic interference (EMI).	IMDRF:C0303
C91801	CDRH Cause Investigation - Investigation Findings Terminology	C139490	Unintended Emission	Problems due to unintended emission of electromagnetic energy by the device.	Unintended Emission	4204	Problems due to unintended emission of electromagnetic energy by the device.	IMDRF:C0304
C91801	CDRH Cause Investigation - Investigation Findings Terminology	C92101	Radiofrequency Interference Identified	Problems due to radiofrequency interference. RFI is a disturbance that affects an electrical circuit due to either electromagnetic conduction or electromagnetic radiation emitted from an external source.	Radiofrequency Interference (RFI)	611	Problems due to radiofrequency interference. RFI is a disturbance that affects an electrical circuit due to either electromagnetic conduction or electromagnetic radiation emitted from an external source.	IMDRF:C0305
C91801	CDRH Cause Investigation - Investigation Findings Terminology	C92070	Interoperability Problem Identified	Problems with the mechanical, electrical, or communication interface between two or more separate devices.	Interoperability Problem Identified	3213	Problems with the mechanical, electrical, or communication interface between two or more separate devices.	IMDRF:C04
C91801	CDRH Cause Investigation - Investigation Findings Terminology	C92034	Communications Problem Identified	Devices that do not send or receive adequate signals (this speaks to the interoperability between devices).	Communications Problem Identified	628	Devices that do not send or receive adequate signals (this speaks to the interoperability between devices).	IMDRF:C0401
C91801	CDRH Cause Investigation - Investigation Findings Terminology	C92131	Wired Communication Problem	Communications problems between devices within a wired system.	Wired Communication Problem	608	Communications problems between devices within a wired system.	IMDRF:C040101
C91801	CDRH Cause Investigation - Investigation Findings Terminology	C92132	Wireless Communication Problem Identified	Communications problems between devices within a wireless system.	Wireless Communication Problem	3248	Communications problems between devices within a wireless system.	IMDRF:C040102
C91801	CDRH Cause Investigation - Investigation Findings Terminology	C139488	Network Communication Problem	Communications problems between devices within a network system.	Network Communication Problem	4205	Communications problems between devices within a network system.	IMDRF:C040103
C91801	CDRH Cause Investigation - Investigation Findings Terminology	C92066	Incompatible Component/Accessory	A device that malfunctions due to a component(s)/accessory that does not operate correctly and according to the device's specifications.	Incompatible Component/ Accessory	102	A device that malfunctions due to a component(s)/accessory that does not operate correctly and according to the device's specifications.	IMDRF:C0402
C91801	CDRH Cause Investigation - Investigation Findings Terminology	C139494	Device Not Compatible With Another Device	A device that malfunctions due to being used in combination with, or in the presence of, another device.	Device Not Compatible With Another Device	4206	A device that malfunctions due to being used in combination with, or in the presence of, another device.	IMDRF:C0403
C91801	CDRH Cause Investigation - Investigation Findings Terminology	C139495	Unintended Compatibility	The device was confirmed to be compatible with another device with which the device is intended to be incompatible.	Unintended Compatibility	4207	The device was confirmed to be compatible with another device with which the device is intended to be incompatible.	IMDRF:C0404
C91801	CDRH Cause Investigation - Investigation Findings Terminology	C92071	Labeling and Instructions for Use/Maintenance	Insufficient, inadequate, or incorrect information provided on a device's label or documentation regarding e.g. its intended use, directions for use, and characteristics of the device, including its maintenance.	Labeling and Instructions for Use/Maintenance	150	Insufficient, inadequate, or incorrect information provided on a device's label or documentation regarding e.g. its intended use, directions for use, and characteristics of the device, including its maintenance.	IMDRF:C05
C91801	CDRH Cause Investigation - Investigation Findings Terminology	C92137	Inadequate Labeling and/or Instructions for Use	Inadequate information on the labels or in the instructions for use e.g. steps that are difficult to follow or that are missing.	Inadequate Labelling and/or Instructions for Use	154	Inadequate information on the labels or in the instructions for use e.g. steps that are difficult to follow or that are missing.	IMDRF:C0501
C91801	CDRH Cause Investigation - Investigation Findings Terminology	C92136	Incorrect Labeling and/or Instructions for Use	Missing, incorrect, or inappropriate information on the labels e.g. mislabeled contents or device labeling characteristics or package contents	Incorrect Labeling and/or Instructions for Use	156	Missing, incorrect, or inappropriate information on the labels e.g. mislabeled contents or device labeling characteristics or package contents.	IMDRF:C0502
C91801	CDRH Cause Investigation - Investigation Findings Terminology	C139496	Inadequate or Incorrect Instructions for Maintenance	Inadequate or incorrect information in the instructions for maintenance.	Inadequate or Incorrect Instructions for Maintenance	4208	Inadequate or incorrect information in the instructions for maintenance.	IMDRF:C0503
C91801	CDRH Cause Investigation - Investigation Findings Terminology	C92078	Material and/or Chemistry Problem Identified	Problems with the device materials or how its materials react to other elements either within the device or within the environment.	Material and/or Chemical Problem Identified	174	Problems with the device materials or how its materials react to other elements either within the device or within the environment.	IMDRF:C06
C91801	CDRH Cause Investigation - Investigation Findings Terminology	C92041	Degradation Problem Identified	Problems that occur when the device becomes worn, weakened, corroded, or broken down due to processes such as aging, permeation, and corrosion.	Degradation Problem Identified	135	Problems that occur when the device becomes worn, weakened, corroded, or broken down due to processes such as aging, permeation, and corrosion.	IMDRF:C0601
C91801	CDRH Cause Investigation - Investigation Findings Terminology	C92065	Inappropriate Device Material	Problems that occur due to the presence of a material that should not be present or part of the device.	Inappropriate Material	202	Problems that occur due to the presence of a material that should not be present or part of the device.	IMDRF:C0602
C91801	CDRH Cause Investigation - Investigation Findings Terminology	C92064	Device Improper Composition/Concentration	Problems associated with the improper combination of materials or elements present in the device (e.g. improper composition of the materials of a capacitor).	Improper Composition/ Concentration	3258	Problems associated with the improper combination of materials or elements present in the device (e.g. improper composition of the materials of a capacitor).	IMDRF:C060201
C91801	CDRH Cause Investigation - Investigation Findings Terminology	C92133	Improper Physical Structure	Problems related to the incorrect or inadequate arrangement of the parts, components, elements, or materials.	Improper Physical Structure	3259	Problems related to the incorrect or inadequate arrangement of the parts, components, elements, or materials.	IMDRF:C060202
C91801	CDRH Cause Investigation - Investigation Findings Terminology	C92121	Molecular Structure Problem	Problems related to the presence of an inappropriate molecular geometry somewhere in the device (i.e. the spatial arrangement of atoms in a molecule and the chemical bonds that hold the atoms together).	Molecular Structure Problem	3219	Problems related to the presence of an inappropriate molecular geometry somewhere in the device (i.e. the spatial arrangement of atoms in a molecule and the chemical bonds that hold the atoms together).	IMDRF:C060203
C91801	CDRH Cause Investigation - Investigation Findings Terminology	C139498	Inadequate Physicochemical Properties	Problems that occur due to the physicochemical properties.	Inadequate Physicochemical Properties	4209	Problems that occur due to the physicochemical properties.	IMDRF:C0603
C91801	CDRH Cause Investigation - Investigation Findings Terminology	C92139	Incompatible Material	Problems that occur due to the incompatibility of materials that co-exist simultaneously as part of the device.	Incompatible Material	203	Problems that occur due to the incompatibility of materials that co-exist simultaneously as part of the device.	IMDRF:C0604
C91801	CDRH Cause Investigation - Investigation Findings Terminology	C92103	Reactivity Problem Identified	Problems that occur due to the reactivity of materials (e.g. over-react or under-react).	Reactivity Problem Identified	3231	Problems that occur due to the reactivity of materials (e.g. over-react or under-react).	IMDRF:C0605
C91801	CDRH Cause Investigation - Investigation Findings Terminology	C92124	Tolerance Stack-Up	Problems that result from a combination of specification variances of the components.	Tolerance Stack-Up	176	Problems that result from a combination of specification variances of the components.	IMDRF:C0606
C91801	CDRH Cause Investigation - Investigation Findings Terminology	C92079	Mechanical Problem Identified	Problems that result from internal or external forces including fluids, other objects, or environmental or physiologic influences.	Mechanical Problem Identified	180	Problems that result from internal or external forces including fluids, other objects, or environmental or physiologic influences.	IMDRF:C07
C91801	CDRH Cause Investigation - Investigation Findings Terminology	C92036	Device Migration Problem Identified	A device that has moved from its original location due to external forces (e.g. stent or lead movement).	Device Migration	3207	A device that has moved from its original location due to external forces (e.g. stent or lead movement).	IMDRF:C0701
C91801	CDRH Cause Investigation - Investigation Findings Terminology	C92056	Device Friction Problem Identified	Problems caused by its surface coming in contact with another surface or fluid.	Friction Problem Identified	3253	Problems caused by its surface coming in contact with another surface or fluid.	IMDRF:C0702
C91801	CDRH Cause Investigation - Investigation Findings Terminology	C139500	Leakage/Seal	Problems caused by inadequate/broken seal within the device.	Leakage/Seal	4210	Problems caused by inadequate/broken seal within the device.	IMDRF:C0703
C91801	CDRH Cause Investigation - Investigation Findings Terminology	C92073	Lubrication Problem Identified	Problems that occurred because of the presence of either too much or too little lubricant where required (e.g. connectors, leading to failure mechanisms such as corrosion).	Lubrication Problem Identified	145	Problems that occurred because of the presence of either too much or too little lubricant where required (e.g. connectors, leading to failure mechanisms such as corrosion).	IMDRF:C0704
C91801	CDRH Cause Investigation - Investigation Findings Terminology	C92118	Stiffness Problem Identified	Problems that occurred when its material is either too flexible/pliable or inflexible/rigid when in contact by an applied force.	Stiffness Problem Identified	3242	Problems that occurred when its material is either too flexible/pliable or inflexible/rigid when in contact by an applied force.	IMDRF:C0705
C91801	CDRH Cause Investigation - Investigation Findings Terminology	C92120	Stress Problem Identified	Problems caused by either excessive or inadequate physical force exerted on it by another object resulting in problems e.g. wear, bending, deformation, fracture, fatigue.	Stress Problem Identified	3243	Problems caused by either excessive or inadequate physical force exerted on it by another object resulting in problems e.g. wear, bending, deformation, fracture, fatigue.	IMDRF:C0706
C91801	CDRH Cause Investigation - Investigation Findings Terminology	C92040	Deformation Problem	Problems caused by changes in the shape or size of the device due to an applied force. This can be a result of tensile forces, compressive forces, shear, bending, tensile (pulling), or torsion.	Deformation Problem	3211	Problems caused by changes in the shape or size of the device due to an applied force. This can be a result of tensile forces, compressive forces, shear, bending, tensile (pulling), or torsion.	IMDRF:C070601
C91801	CDRH Cause Investigation - Investigation Findings Terminology	C92053	Device Fatigue Problem	Problems due to the weakening or breakdown of its material when subjected to stress or a series of repeated stresses.	Fatigue Problem	3251	Problems due to the weakening or breakdown of its material when subjected to stress or a series of repeated stresses.	IMDRF:C070602
C91801	CDRH Cause Investigation - Investigation Findings Terminology	C92055	Device Fracture Problem	Problems caused by the separation of a component, object, or material into two or more pieces including shear.	Fracture Problem	3252	Problems caused by the separation of a component, object, or material into two or more pieces including shear.	IMDRF:C070603
C91801	CDRH Cause Investigation - Investigation Findings Terminology	C92080	Mechanical Shock Problem	Problems caused by the sudden violent blow or collision to the whole device (e.g. by dropping).	Mechanical Shock Problem	3217	Problems caused by the sudden violent blow or collision to the whole device (e.g. by dropping).	IMDRF:C070604
C91801	CDRH Cause Investigation - Investigation Findings Terminology	C92129	Vibration Problem	Problems that result from a combination of specification variances of the components.	Vibration Problem	649	Problems caused by the constant rhythmic motion of the device, or something in the environment to which the device is exposed.	IMDRF:C070605
C91801	CDRH Cause Investigation - Investigation Findings Terminology	C92130	Wear Problem	Problems due to the premature or expected erosion of its material by use, deterioration, or change.	Wear Problem	140	Problems due to the premature or expected erosion of its material by use, deterioration, or change.	IMDRF:C070606
C91801	CDRH Cause Investigation - Investigation Findings Terminology	C139499	Incorrect Dimension	Problems caused by incorrect physical dimensions of the device or one of its parts.	Incorrect Dimension	4211	Problems caused by incorrect physical dimensions of the device or one of its parts	IMDRF:C0707
C91801	CDRH Cause Investigation - Investigation Findings Terminology	C92089	Optical Problem Identified	Problems related to the optical properties of a device.	Optical Problem Identified	3224	Problems related to the optical properties of a device.	IMDRF:C08
C91801	CDRH Cause Investigation - Investigation Findings Terminology	C92090	Optical Transmission Problem Identified	Problems with the device's ability to pass light energy.	Optical Transmission Problem Identified	196	Problems with the device's ability to pass light energy.	IMDRF:C0801
C91801	CDRH Cause Investigation - Investigation Findings Terminology	C139502	Light Source Problem Identified	Problems with the optical properties of a device such as diopter, glare, and irradiance or glistening.	Light Source Problem Identified	4212	Problems with the optical properties of a device such as diopter, glare, and irradiance or glistening.	IMDRF:C0802
C91801	CDRH Cause Investigation - Investigation Findings Terminology	C92102	Clinical Imaging Problem Identified	Problems that occur with devices used for radiographic or imaging procedures e.g. CT scanners, magnetic resonance imaging.	Clinical Imaging Problem Identified	3230	Problems that occur with devices used for radiographic or imaging procedures e.g. CT scanners, magnetic resonance imaging.	IMDRF:C09
C91801	CDRH Cause Investigation - Investigation Findings Terminology	C92058	Gradient Induced Field Problem	Problems that result from the gradient-induced fields generated during radiologic procedures e.g. magnetic resonance imaging.	Gradient Induced Field Problem	323	Problems that result from the gradient-induced fields generated during radiologic procedures e.g. magnetic resonance imaging.	IMDRF:C0901
C91801	CDRH Cause Investigation - Investigation Findings Terminology	C92062	Image Artifact	The unacceptable distortion of an image due to signal loss that may occur during a radiologic procedure such as magnetic resonance imaging.	Image Artifact	3256	The unacceptable distortion of an image due to signal loss that may occur during a radiologic procedure such as magnetic resonance imaging.	IMDRF:C0902
C91801	CDRH Cause Investigation - Investigation Findings Terminology	C92074	Magnetically Induced	Problems due to unintended or excessive movement created by the application of magnetic fields.	Magnetically-Induced Movement	3215	Problems due to unintended or excessive movement created by the application of magnetic fields.	IMDRF:C0903
C91801	CDRH Cause Investigation - Investigation Findings Terminology	C92100	Radiofrequency Induced Overheating	Problems due to unintended radiofrequency-induced temperature increase that can occur in the vicinity of the device.	Radiofrequency Induced Overheating	3229	Problems due to unintended radiofrequency-induced temperature increase that can occur in the vicinity of the device.	IMDRF:C0904
C91801	CDRH Cause Investigation - Investigation Findings Terminology	C92113	Software Problem Identified	Problems related to the device software.	Software Problem Identified	104	Problems related to the device software.	IMDRF:C10
C91801	CDRH Cause Investigation - Investigation Findings Terminology	C92038	Configuration Issue	Problems due to change control or incorrect version, including regional requirements.	Configuration Issue	3208	Problems due to change control or incorrect version, including regional requirements.	IMDRF:C1001
C91801	CDRH Cause Investigation - Investigation Findings Terminology	C92042	Design Error	The device had faulty (incomplete or incorrect) software design.	Design Error	110	The device had faulty (incomplete or incorrect) software design.	IMDRF:C1002
C91801	CDRH Cause Investigation - Investigation Findings Terminology	C92039	Data Compression Error	Data was lost or corrupted during the operation of reducing storage space or communication bandwidth.	Data Compression Error	663	Data was lost or corrupted during the operation of reducing storage space or communication bandwidth.	IMDRF:C100201
C91801	CDRH Cause Investigation - Investigation Findings Terminology	C92142	Incorrect Algorithm	The device software was found to implement an incorrect sequence of steps for a specific computation.	Incorrect Algorithm	618	The device software was found to implement an incorrect sequence of steps for a specific computation.	IMDRF:C100202
C91801	CDRH Cause Investigation - Investigation Findings Terminology	C92141	Incorrect Data Definition	The device software was found to contain errors in specifying or manipulating data items.	Incorrect Data Definition	3200	The device software was found to contain errors in specifying or manipulating data items.	IMDRF:C100203
C91801	CDRH Cause Investigation - Investigation Findings Terminology	C92069	Interface Design Error	The device software was found to contain errors in the user interface (including usability problems) or the interfaces with other systems.	Interface Design Error	113	The device software was found to contain errors in the user interface (including usability problems) or the interfaces with other systems.	IMDRF:C100204
C91801	CDRH Cause Investigation - Investigation Findings Terminology	C92085	Non-Functional Defect	The device software contained software errors that did not impact its operation.	Non-Functional Defect	3222	The device software contained software errors that did not impact its operation.	IMDRF:C100205
C91801	CDRH Cause Investigation - Investigation Findings Terminology	C92117	Software Timing Problem	Problems that results from the incorrect sequencing or activation of software modules.	Software Timing Problem	634	Problems that results from the incorrect sequencing or activation of software modules.	IMDRF:C100206
C91801	CDRH Cause Investigation - Investigation Findings Terminology	C139516	Software Maintenance Problem Identified	The device software was not maintained/updated properly.	Software Maintenance Problem Identified	4213	The device software was not maintained/updated properly.	IMDRF:C1003
C91801	CDRH Cause Investigation - Investigation Findings Terminology	C92111	Software Installation Problem Identified	The device software was not installed as per the specifications or failed to properly install.	Software Installation Problem Identified	3238	The device software was not installed as per the specifications or failed to properly install.	IMDRF:C1004
C91801	CDRH Cause Investigation - Investigation Findings Terminology	C92114	Software Requirement Error	The software requirements for the device are either incomplete, inadequate, or in conflict.	Software Requirement Error	3239	The software requirements for the device are either incomplete, inadequate, or in conflict.	IMDRF:C1005
C91801	CDRH Cause Investigation - Investigation Findings Terminology	C92115	Software Runtime Error	The device software failed during operation as a result of a coding error.	Software Runtime Error	3240	The device software failed during operation as a result of a coding error.	IMDRF:C1006
C91801	CDRH Cause Investigation - Investigation Findings Terminology	C92116	Software Security Vulnerability	The device software failed to provide adequate authorization, access control, protection and accountability features.	Software Security Vulnerability	3241	The device software failed to provide adequate authorization, access control, protection and accountability features.	IMDRF:C1007
C91801	CDRH Cause Investigation - Investigation Findings Terminology	C139515	Erroneous Data Transfer	The device software fails to transfer the expected data within a system or to another device.	Erroneous Data Transfer	4214	The device software fails to transfer the expected data within a system or to another device.	IMDRF:C1008
C91801	CDRH Cause Investigation - Investigation Findings Terminology	C139514	Data Storage or Loss of Data	Storage of data was unsuccessful in total or in part.	Data Storage or Loss of Data	4215	Storage of data was unsuccessful in total or in part.	IMDRF:C1009
C91801	CDRH Cause Investigation - Investigation Findings Terminology	C187263	Artificial Intelligence Training/Validation Problem Identified	Problem associated with the training and/or validation of artificial intelligence, including machine learning algorithms.	Artificial Intelligence Training/Validation Problem Identified	4249	Problem associated with the training and/or validation of artificial intelligence, including machine learning algorithms.	IMDRF:C1010
C91801	CDRH Cause Investigation - Investigation Findings Terminology	C187264	Corrupt Software	The device software becomes corrupted and results in device malfunction.	Corrupt Software	4250	The device software becomes corrupted and results in device malfunction.	IMDRF:C1011
C91801	CDRH Cause Investigation - Investigation Findings Terminology	C92122	Thermal Problem	Problems related to the temperature of the device.	Thermal Problem	642	Problems related to the temperature of the device. Note: For problems related to environmental temperature use ''Environment Problem Identified''.	IMDRF:C11
C91801	CDRH Cause Investigation - Investigation Findings Terminology	C139520	Overheating Problem Identified	The device was found to become hotter than expected during operation. This applies to devices which are not intended to deliver heat.	Overheating Problem Identified	4216	The device was found to become hotter than expected during operation. This applies to devices which are not intended to deliver heat. Use "Excessive heating identified" for devices which are intended to deliver heat during operation. Use "Inadequate cooling identified" if the overheating was related to a problem with a cooling system.	IMDRF:C1101
C91801	CDRH Cause Investigation - Investigation Findings Terminology	C139518	Excessive Heating Identified	The device delivered more heat than intended or expected during operation. This applies to devices which are intended to deliver heat.	Excessive Heating Identified	4217	The device delivered more heat than intended or expected during operation. This applies to devices which are intended to deliver heat. Use "Overheating problem identified" for devices which are not intended to deliver heat during operation.	IMDRF:C1102
C91801	CDRH Cause Investigation - Investigation Findings Terminology	C139517	Excessive Cooling Identified	The device cooled the patient or another device more than intended or expected during operation.	Excessive Cooling Identified	4218	The device cooled the patient or another device more than intended or expected during operation.	IMDRF:C1103
C91801	CDRH Cause Investigation - Investigation Findings Terminology	C139519	Inadequate Cooling Identified	The device did not sufficiently cool the patient or another device during operation.	Inadequate Cooling Identified	4219	The device did not sufficiently cool the patient or another device during operation.	IMDRF:C1104
C91801	CDRH Cause Investigation - Investigation Findings Terminology	C92098	Protective System Problem Identified	Problems related to the system(s) designed to prevent or warn about unsafe operation of the device.	Protective System Problem Identified	3228	Problems related to the system(s) designed to prevent or warn about unsafe operation of the device.	IMDRF:C12
C91801	CDRH Cause Investigation - Investigation Findings Terminology	C139507	Fail-safe Problem Identified	A system intended to prevent unsafe operation of the device did not operate correctly.	Fail-safe Problem Identified	4220	A system intended to prevent unsafe operation of the device did not operate correctly.	IMDRF:C1201
C91801	CDRH Cause Investigation - Investigation Findings Terminology	C139506	Alarm System Problem Identified	A system intended to warn of a potentially unsafe condition did not operate correctly.	Alarm System Problem Identified	4221	A system intended to warn of a potentially unsafe condition did not operate correctly.	IMDRF:C1202
C91801	CDRH Cause Investigation - Investigation Findings Terminology	C139510	Problem of Device to Self-Test	Malfunction of the device's self-test system.	Problem of Device to Self-Test	4222	Malfunction of the device's self-test system.	IMDRF:C1203
C91801	CDRH Cause Investigation - Investigation Findings Terminology	C139511	Problem to Auto Stop	An auto stop function of a device did not operate correctly.	Problem to Auto Stop	4223	An auto stop function of a device did not operate correctly.	IMDRF:C1204
C91801	CDRH Cause Investigation - Investigation Findings Terminology	C139509	Premature Indicator Activation	A system intended to indicate the device status was triggered prematurely.	Premature Indicator Activation	4224	A system intended to indicate the device status was triggered prematurely.	IMDRF:C1205
C91801	CDRH Cause Investigation - Investigation Findings Terminology	C139512	Reset Problem	The device does not reset properly.	Reset Problem	4225	The device does not reset properly.	IMDRF:C1206
C91801	CDRH Cause Investigation - Investigation Findings Terminology	C139513	Shielding Problem	Inadequate shielding of/by the device.	Shielding Problem	4226	Inadequate shielding of/by the device.	IMDRF:C1207
C91801	CDRH Cause Investigation - Investigation Findings Terminology	C139508	Missing or Inadequate Safety Measures Identified	Safety measures are inadequately applied or missing.	Missing or Inadequate Safety Measures	4227	Safety measures are inadequately applied or missing.	IMDRF:C1208
C91801	CDRH Cause Investigation - Investigation Findings Terminology	C92088	Operational Problem Identified	Problems that occur during the performance, use, or functioning of the device.	Operational Problem Identified	114	Problems that occur during the performance, use, or functioning of the device.	IMDRF:C13
C91801	CDRH Cause Investigation - Investigation Findings Terminology	C139575	Device Incorrectly Reprocessed	Problems associated with the failure to properly and adequately reprocess the device.	Device Incorrectly Reprocessed	4228	Problems associated with the failure to properly and adequately reprocess the device.	IMDRF:C1301
C91801	CDRH Cause Investigation - Investigation Findings Terminology	C139486	Device Incorrectly Cleaned During Reprocessing	The cleaning procedure is not followed correctly or used inappropriate cleaning materials.	Device Incorrectly Cleaned During Reprocessing	4229	The cleaning procedure is not followed correctly or used inappropriate cleaning materials.	IMDRF:C130101
C91801	CDRH Cause Investigation - Investigation Findings Terminology	C139487	Device Incorrectly Disinfected/Sterilized During Reprocessing	The disinfection/sterilization process was incorrect and/or the wrong products for disinfection/sterilization were used.	Device Incorrectly Disinfected/Sterilised During Reprocessing	4230	The disinfection/sterilization process was incorrect and/or the wrong products for disinfection/sterilization were used.	IMDRF:C130102
C91801	CDRH Cause Investigation - Investigation Findings Terminology	C139485	Device Incorrectly Assembled During Reprocessing	Incorrect assembly of the device following reprocessing.	Device Incorrectly Assembled During Reprocessing	4231	Incorrect assembly of the device following reprocessing.	IMDRF:C130103
C91801	CDRH Cause Investigation - Investigation Findings Terminology	C92052	Failure to Calibrate Identified	A device that cannot calibrate (establish the relationship between a measuring device and the units of measure) to ensure accurate readings.	Failure to Calibrate	3250	A device that cannot calibrate (establish the relationship between a measuring device and the units of measure) to ensure accurate readings.	IMDRF:C1302
C91801	CDRH Cause Investigation - Investigation Findings Terminology	C91870	Device Difficult to Operate	Problems including set-up, operation, and disassembly of equipment. Not including reprocessing.	Device Difficult to Operate	13	Problems including set-up, operation, and disassembly of equipment. Not including reprocessing.	IMDRF:C1303
C91801	CDRH Cause Investigation - Investigation Findings Terminology	C139501	Incorrect Interpretation of Results/Data	Problems resulting from the incorrect interpretation by the user of the results or data provided by the device.	Incorrect Interpretation of Results/Data	4232	Problems resulting from the incorrect interpretation by the user of the results or data provided by the device.	IMDRF:C1304
C91801	CDRH Cause Investigation - Investigation Findings Terminology	C139467	Patient Sample Problem	Problems that occurred due to endogenous or exogenous interferent in the sample, or unexpected variation in the target analyte/marker.	Patient Sample Problem	4233	Problems that occurred due to endogenous or exogenous interferent in the sample, or unexpected variation in the target analyte/marker.	IMDRF:C14
C91801	CDRH Cause Investigation - Investigation Findings Terminology	C139523	New or Unknown Interferent	New or unknown endogenous or exogenous interferent (sample) identified.	New or Unknown Interferent	4234	New or unknown endogenous or exogenous interferent (sample) identified.	IMDRF:C1401
C91801	CDRH Cause Investigation - Investigation Findings Terminology	C139522	Known Interferent	Known interferent in the sample identified.	Known Interferent	4235	Known interferent in the sample identified.	IMDRF:C1402
C91801	CDRH Cause Investigation - Investigation Findings Terminology	C139521	Change in Target Marker/Variant/Mutant	Problem due to change in target marker/variant/mutant which is not covered in the labeling.	Change in Target Marker/Variant/ Mutant	4236	Problem due to change in target marker/variant/mutant which is not covered in the labelling.	IMDRF:C1403
C91801	CDRH Cause Investigation - Investigation Findings Terminology	C139524	Pre-analytical Handling Problem	Incorrect pre-analytical handling of patient's sample by the user.	Pre-analytical Handling Problem	4237	Incorrect pre-analytical handling of patient's sample by the user.	IMDRF:C1404
C91801	CDRH Cause Investigation - Investigation Findings Terminology	C92051	Environment Problem Identified	Problems that occurred due to factors within the environment e.g. dust, dirt, humidity, temperature.	Environment Problem Identified	331	Problems that occurred due to factors within the environment e.g. dust, dirt, humidity, temperature.	IMDRF:C15
C91801	CDRH Cause Investigation - Investigation Findings Terminology	C92134	Environmental Temperature Problem Identified	Device performance was affected by the temperature, or changes in temperature, of the environment in which it was used.	Environmental Temperature Problem Identified	651	Device performance was affected by the temperature, or changes in temperature, of the environment in which it was used.	IMDRF:C1501
C91801	CDRH Cause Investigation - Investigation Findings Terminology	C92043	Dust or Dirt Problem Identified	A device that experienced problems due to ingress, or coating, of dust or dirt.	Dust or Dirt Problem Identified	646	A device that experienced problems due to ingress, or coating, of dust or dirt.	IMDRF:C1502
C91801	CDRH Cause Investigation - Investigation Findings Terminology	C139492	Contamination of Environment by Device	Operation of the device results in contamination of the nearby environment e.g. dust, dirt, smoke, heat or biological material.	Contamination of Environment by Device	4238	Operation of the device results in contamination of the nearby environment e.g. dust, dirt, smoke, heat or biological material.	IMDRF:C1503
C91801	CDRH Cause Investigation - Investigation Findings Terminology	C139493	Environmental Pressure Problem Identified	Device performance was affected by the pressure, or changes in pressure, of the environment in which it was used.	Environmental Pressure Problem Identified	4239	Device performance was affected by the pressure, or changes in pressure, of the environment in which it was used.	IMDRF:C1504
C91801	CDRH Cause Investigation - Investigation Findings Terminology	C139491	Ambient Light Problem Identified	Device performance was affected by ambient light. This term applies to the direct effects of ambient light on the device, and to the user's ability to operate the device (e.g. to read device output).	Ambient Light Problem Identified	4240	Device performance was affected by ambient light. This term applies to the direct effects of ambient light on the device, and to the user's ability to operate the device (e.g. to read device output).	IMDRF:C1505
C91801	CDRH Cause Investigation - Investigation Findings Terminology	C92061	Environmental Humidity Problem Identified	Device performance was affected by the humidity, or changes in humidity, of the environment in which it was used.	Environmental Humidity Problem Identified	332	Device performance was affected by the humidity, or changes in humidity, of the environment in which it was used.	IMDRF:C1506
C91801	CDRH Cause Investigation - Investigation Findings Terminology	C92076	Manufacturing Process Problem Identified	Problems with a device that can be traced to a problem in the manufacturing and/or production process.	Manufacturing Process Problem Identified	170	Problems with a device that can be traced to a problem in the manufacturing and/or production process.	IMDRF:C16
C91801	CDRH Cause Investigation - Investigation Findings Terminology	C92028	Assembly Problem Identified	Problems that occurred because the device was assembled incorrectly.	Assembly Problem Identified	706	Problems that occurred because the device was assembled incorrectly.	IMDRF:C1601
C91801	CDRH Cause Investigation - Investigation Findings Terminology	C139576	Sterilization Problem Identified	Problems that occurred during terminal sterilization by the manufacturer.	Sterilization Problem Identified	4241	Problems that occurred during terminal sterilization by the manufacturer.	IMDRF:C1602
C91801	CDRH Cause Investigation - Investigation Findings Terminology	C92067	Installation Problem Identified	A device that malfunctions because it was incorrectly installed, set-up, or configured (e.g. misconfiguration of an "automatic" defibrillator to "semi-automatic", thereby leading to failure).	Installation Problem Identified	3201	A device that malfunctions because it was incorrectly installed, set-up, or configured (e.g. misconfiguration of an "automatic" defibrillator to "semi-automatic", thereby leading to failure).	IMDRF:C1603
C91801	CDRH Cause Investigation - Investigation Findings Terminology	C139497	Maintenance of Manufacturing Machinery	Problems caused by failure to maintain manufacturing equipment used to produce the device.	Maintenance of Manufacturing Machinery	4242	Problems caused by failure to maintain manufacturing equipment used to produce the device.	IMDRF:C1604
C91801	CDRH Cause Investigation - Investigation Findings Terminology	C92094	Packaging Problem Identified	Problems that occurred because of the device packaging.	Packaging Problem Identified	111	Problems that occurred because of the device packaging.	IMDRF:C1605
C91801	CDRH Cause Investigation - Investigation Findings Terminology	C92093	Packaging Compromised	Problems that occurred because of a compromised packaging of the device (e.g. broken or incomplete seal).	Packaging Compromised	171	Problems that occurred because of a compromised packaging of the device (e.g. broken or incomplete seal).	IMDRF:C160501
C91801	CDRH Cause Investigation - Investigation Findings Terminology	C139505	Packaging Materials Problem	Problems that occurred because of the composition or type of packaging materials was inappropriate for the device.	Packaging Materials Problem	4243	Problems that occurred because of the composition or type of packaging materials was inappropriate for the device.	IMDRF:C160502
C91801	CDRH Cause Investigation - Investigation Findings Terminology	C139504	Packaging Contains Unintended Material	Problems that occurred because unintended material was packaged with the device.	Packaging Contains Unintended Material	4244	Problems that occurred because unintended material was packaged with the device.	IMDRF:C160503
C91801	CDRH Cause Investigation - Investigation Findings Terminology	C139503	Packaging Contains Incorrect Device	Problems that occurred because the packaging contained an incorrect device.	Packaging Contains Incorrect Device	4245	Problems that occurred because the packaging contained an incorrect device.	IMDRF:C160504
C91801	CDRH Cause Investigation - Investigation Findings Terminology	C92075	Maintenance Problem Identified	A device malfunction or problem that occurs after production because the device was not properly maintained according to the instructions (e.g. maintenance may be performed by user facility, distributor, or service provider).	Maintenance Problem Identified	115	A device malfunction or problem that occurs after production because the device was not properly maintained according to the instructions (e.g. maintenance may be performed by user facility, distributor, or service provider).	IMDRF:C17
C91801	CDRH Cause Investigation - Investigation Findings Terminology	C139468	Transport/Storage Problem Identified	Problems was caused by transport or storage conditions.	Transport/Storage Problem Identified	4246	Problems was caused by transport or storage conditions.	IMDRF:C18
C91801	CDRH Cause Investigation - Investigation Findings Terminology	C92107	Transport Problem Identified	Problems traced to how the device was transported e.g. temperature of shipping compartment or method of transportation.	Transport Problem Identified	3236	Problems traced to how the device was transported e.g. temperature of shipping compartment or method of transportation.	IMDRF:C1801
C91801	CDRH Cause Investigation - Investigation Findings Terminology	C92119	Storage Problem Identified	Problems that result from storing the device in an uncontrolled or improper environment (e.g. moisture sensitive devices stored in a humid environment).	Storage Problem Identified	193	Problems that result from storing the device in an uncontrolled or improper environment (e.g. moisture sensitive devices stored in a humid environment).	IMDRF:C1802
C91801	CDRH Cause Investigation - Investigation Findings Terminology	C92083	No Device Problem Found	The device either functioned as intended or a problem was not found.	No Device Problem Found	213	Reported problem cannot be reproduced during investigation.	IMDRF:C19
C91801	CDRH Cause Investigation - Investigation Findings Terminology	C92084	No Findings Available	Use when no investigation can be performed and therefore no results will be obtained.	No Findings Available	3221	Use when no investigation can be performed and therefore no results will be obtained.	IMDRF:C20
C91801	CDRH Cause Investigation - Investigation Findings Terminology	C92143	Results Pending Completion of Investigation	Investigation is ongoing and results are not yet available. Do not use this code if the investigation is complete.	Results Pending Completion of Investigation	3233	Investigation is ongoing and results are not yet available. Do not use this code if the investigation is complete.	IMDRF:C21
C91801	CDRH Cause Investigation - Investigation Findings Terminology	C139466	Appropriate Term/Code Not Available Identified	Problems is not adequately described by any other term.	Appropriate Term/Code Not Available	4247	Problems is not adequately described by any other term. Note: This code must not be used unless there is no other feasible code. The preferred term should be documented when submitting an adverse event report. This information will be used to determine if a new term should be added to the code table.	IMDRF:C22
C91801	CDRH Cause Investigation - Investigation Findings Terminology	C177429	Usage Problem Identified	Problems that occured related to the actions of a healthcare professional, patient, or other device user.	Usage Problem Identified	4248	Problems that occurred related to the actions of a healthcare professional, patient, or other device user.	IMDRF:C23
C91802	CDRH Cause Investigation - Investigation Conclusion Terminology	C91869	Cause Traced to Device Design	Problems traced to the design specifications (e.g. in the requirements, testing processes, hazard analysis, implementation strategy).	Cause Traced to Device Design	12	Problems traced to the design specifications (e.g. in the requirements, testing processes, hazard analysis, implementation strategy).	IMDRF:D01
C91802	CDRH Cause Investigation - Investigation Conclusion Terminology	C139477	Design Inadequate for Purpose	Problems traced to design/design features of the device that do not support or interfere with the intended purpose of the device.	Design Inadequate for Purpose	4301	Problems traced to design/design features of the device that do not support or interfere with the intended purpose of the device.	IMDRF:D0101
C91802	CDRH Cause Investigation - Investigation Conclusion Terminology	C139479	Human Factors Engineering - Device Difficult to Operate	Problems traced to inappropriate and/or inadequate assessment and engineering design of the device to accommodate how or where the device will be used.	Human Factors Engineering - Device Difficult to Operate	4302	Problems traced to inappropriate and/or inadequate assessment and engineering design of the device to accommodate how or where the device will be used.	IMDRF:D0102
C91802	CDRH Cause Investigation - Investigation Conclusion Terminology	C139478	Human Factors Engineering - Device Difficult to Assemble	Problems traced to inadequate design of the component parts and/or assembly steps resulting in the device not being able to be assembled correctly.	Human Factors Engineering - Device Difficult to Assemble	4303	Problems traced to inadequate design of the component parts and/or assembly steps resulting in the device not being able to be assembled correctly.	IMDRF:D0103
C91802	CDRH Cause Investigation - Investigation Conclusion Terminology	C139480	Human Factors Engineering - Device Difficult to Reprocess	Problems traced to inadequate design of the reprocessing steps and/or the device resulting in the device remaining unclean.	Human Factors Engineering - Device Difficult to Reprocess	4304	Problems traced to inadequate design of the reprocessing steps and/or the device resulting in the device remaining unclean.	IMDRF:D0104
C91802	CDRH Cause Investigation - Investigation Conclusion Terminology	C139481	Missing or Inadequate Safety Measures Problem	Problems traced to inadequate design or complete lack of safety measures leading to device malfunction or unintended properties of the device including possible hazards for persons using the device.	Missing or Inadequate Safety Measures	4305	Problems traced to inadequate design or complete lack of safety measures leading to device malfunction or unintended properties of the device including possible hazards for persons using the device.	IMDRF:D0105
C91802	CDRH Cause Investigation - Investigation Conclusion Terminology	C139476	Design Change Validation Inadequate	Problems traced to inadequate or lack of validation of design changes of the device leading to malfunction or unintended properties of the device including possible hazards for persons using the device.	Design Change Validation Inadequate	4306	Problems traced to inadequate or lack of validation of design changes of the device leading to malfunction or unintended properties of the device including possible hazards for persons using the device.	IMDRF:D0106
C91802	CDRH Cause Investigation - Investigation Conclusion Terminology	C177431	Inadequate Cybersecurity	Problems traced to inadequate protection of computers, servers, mobile devices, electronic systems, networks, programs, and data from malicious attacks, damage, or unauthorized access.	Inadequate Cybersecurity	4317	Problems traced to inadequate protection of computers, servers, mobile devices, electronic systems, networks, programs, and data from malicious attacks, damage, or unauthorized access.	IMDRF:D0107
C91802	CDRH Cause Investigation - Investigation Conclusion Terminology	C177433	Inadequate Software Design	Cause traced to inadequate or inappropriate design of the software component of a medical device, or software as a medical device.	Inadequate Software Design.	4318	Cause traced to inadequate or inappropriate design of the software component of a medical device, or Software as a Medical Device.	IMDRF:D0108
C91802	CDRH Cause Investigation - Investigation Conclusion Terminology	C139472	Cause Traced to Component Failure	Expected or random component failure without any design or manufacturing issue.	Cause Traced to Component Failure	4307	Expected or random component failure without any design or manufacturing issue.	IMDRF:D02
C91802	CDRH Cause Investigation - Investigation Conclusion Terminology	C91885	Cause Traced to Manufacturing	A defect in the processes or systems used in the manufacture of the device. Examples include problems within the change control, production, or quality control processes.	Cause Traced to Manufacturing	25	A defect in the processes or systems used in the manufacture of the device. Examples include problems within the change control, production, or quality control processes.	IMDRF:D03
C91802	CDRH Cause Investigation - Investigation Conclusion Terminology	C91881	Manufacturing Deficiency	Problems traced to manufacturing process.	Manufacturing Deficiency	23	Problems traced to manufacturing process.	IMDRF:D0301
C91802	CDRH Cause Investigation - Investigation Conclusion Terminology	C92099	Quality Control Deficiency	Problems traced to the failure to maintain or establish techniques for controlling and verifying the product specifications (including materials used) identified by the manufacturer himself.	Quality Control Deficiency	143	Problems traced to the failure to maintain or establish techniques for controlling and verifying the product specifications (including materials used) identified by the manufacturer himself.	IMDRF:D0302
C91802	CDRH Cause Investigation - Investigation Conclusion Terminology	C139474	Cause Traced to Transport/Storage	Problems traced to the inappropriate transport or storage of the device.	Cause Traced to Transport/Storage	4308	Problems traced to the inappropriate transport or storage of the device.	IMDRF:D04
C91802	CDRH Cause Investigation - Investigation Conclusion Terminology	C91877	Cause Traced to Infrastructure	The undesirable presence of living organisms such as bacteria, fungi, or viruses or their products (enzymes or toxins).	Cause Traced to Infrastructure	21	Problems traced to underlying framework, systems, and processes at the healthcare facility or other point of use (e.g. as building power supply, network, oxygen systems).	IMDRF:D05
C91802	CDRH Cause Investigation - Investigation Conclusion Terminology	C139473	Cause Traced to Environment	Problems caused by exposure to environmental conditions outside the expected range.	Cause Traced to Environment	4309	Problems caused by exposure to environmental conditions outside the expected range.	IMDRF:D06
C91802	CDRH Cause Investigation - Investigation Conclusion Terminology	C91880	Cause Traced to Maintenance	Problems traced to improper routine or preventative maintenance.	Cause Traced to Maintenance	51	Problems traced to improper routine or preventative maintenance.	IMDRF:D07
C91802	CDRH Cause Investigation - Investigation Conclusion Terminology	C91889	Cause Traced to Training	Problems caused by inadequate training.	Cause Traced to Training	27	Problems caused by inadequate training.	IMDRF:D08
C91802	CDRH Cause Investigation - Investigation Conclusion Terminology	C91879	Cause Traced to Labeling	Problems that occur as the result of problems with the labeling (including package inserts, instruction manuals, instructions for use).	Cause Traced to Labeling	57	Problems that occur as the result of problems with the labeling (including package inserts, instruction manuals, instructions for use).	IMDRF:D09
C91802	CDRH Cause Investigation - Investigation Conclusion Terminology	C139470	Cause Cannot be Traced to Device	The adverse event that occurred is not attributable to a device.	Caused traced to non-device related factors	4310	The adverse event that occurred is confirmed to have been caused by something other than the device or usage.	IMDRF:D10
C91802	CDRH Cause Investigation - Investigation Conclusion Terminology	C91872	Adverse Event Related to Patient Condition	An existing condition or disease is demonstrably responsible for the adverse event and use of the device has neither caused nor otherwise influenced this condition/disease-related adverse event.	Adverse Event Related to Patient Condition	50	An existing condition or disease is demonstrably responsible for the adverse event and use of the device has neither caused nor otherwise influenced this condition/disease-related adverse event.	IMDRF:D1001
C91802	CDRH Cause Investigation - Investigation Conclusion Terminology	C139526	Adverse Event Related to Procedure	The adverse event occurred during the procedure and the device had no influence on event.	Adverse Event Related to Procedure	4311	The adverse event occurred during the procedure and the device had no influence on event.	IMDRF:D1002
C91802	CDRH Cause Investigation - Investigation Conclusion Terminology	C139525	Adverse Event Related to Commutability	The adverse event occurred because the material being used to calibrate or assess IVD performance did not have similar properties to those of human samples, leading to inappropriate bias and erroneous results. Examples of materials include: reference materials, calibrators, proficiency testing samples.	Adverse Event Related to Commutability	4312	The adverse event occurred because the material being used to calibrate or assess IVD performance did not have similar properties to those of human samples, leading to inappropriate bias and erroneous results. Examples of materials include: reference materials, calibrators, proficiency testing samples.	IMDRF:D1003
C91802	CDRH Cause Investigation - Investigation Conclusion Terminology	C91874	Cause Traced to User	The adverse event was caused partially or wholly by the user of the device including sample handling.	Cause Traced to User	19	The adverse event caused partially or wholly by the user of the device including sample handling.	IMDRF:D11
C91802	CDRH Cause Investigation - Investigation Conclusion Terminology	C91873	Failure to Follow Instructions	Problems traced to the user not following the manufacturer's instructions.	Failure To Follow Instructions	18	Problems traced to the user not following the manufacturer's instructions.	IMDRF:D1101
C91802	CDRH Cause Investigation - Investigation Conclusion Terminology	C91895	Unintended Use Error Caused or Contributed to Event	The interaction between the user and device, or sample, caused or contributed to the error. This includes unintended inappropriate use of the device and incorrect sample preparation.	Unintended Use Error Caused or Contributed to Event	61	The interaction between the user and device, or sample, caused or contributed to the error. This includes unintended inappropriate use of the device and incorrect sample preparation.	IMDRF:D1102
C91802	CDRH Cause Investigation - Investigation Conclusion Terminology	C91892	Cause Traced to Intentional Off-Label, Unapproved, or Contraindicated Use	Problems traced to the intentional use of the device in an unapproved procedure, for an unapproved patient, or for which it is contraindicated, or not listed on the label.	Cause Traced to Intentional Off-Label, Unapproved, or Contraindicated Use	24	Problems traced to the intentional use of the device in an unapproved procedure, for an unapproved patient, or for which it is contraindicated, or not listed on the label.	IMDRF:D1103
C91802	CDRH Cause Investigation - Investigation Conclusion Terminology	C92106	Shelf Life/Expiration Date Exceeded	A device that has exceeded the period of time/date recommended by the manufacturer for storing the device without a degradation in quality.	Shelf Life/Expiration Date Exceeded	192	A device that has exceeded the period of time/date recommended by the manufacturer for storing the device without a degradation in quality.	IMDRF:D1104
C91802	CDRH Cause Investigation - Investigation Conclusion Terminology	C92048	End of Life Problem Identified	Problems traced to the device reaching the end of its useful life.	End of Life Problem Identified	133	Problems traced to the device reaching the end of its useful life.	IMDRF:D1105
C91802	CDRH Cause Investigation - Investigation Conclusion Terminology	C91893	Reuse of Single Use Device	Problems traced to the use of the device more than once when it is designed for only one use.	Reuse of Single Use Device	26	Problems traced to the use of the device more than once when it is designed for only one use.	IMDRF:D1106
C91802	CDRH Cause Investigation - Investigation Conclusion Terminology	C139482	Sabotage or Intentional Misuse	Problems occurred because of willful damage or reckless misuse. This term indicates that there was an apparent intent to cause damage or injury.	Sabotage or Intentional Misuse	4313	Problems occurred because of willful damage or reckless misuse. This term indicates that there was an apparent intent to cause damage or injury.	IMDRF:D1107
C91802	CDRH Cause Investigation - Investigation Conclusion Terminology	C187265	Reasonably Foreseeable Misuse	Problems related to the use of a device in a way not intended in the instructions for use, but which may result from readily predictable human behavior.	Reasonably Foreseeable Misuse	4319	Problems related to the use of a device in a way not intended in the instructions for use, but which may result from readily predictable human behavior.	IMDRF:D1108
C91802	CDRH Cause Investigation - Investigation Conclusion Terminology	C91878	Known Inherent Risk of Device	Reported adverse event known and documented in the labeling (including both short or long term known complications or adverse reactions).	Known Inherent Risk of Device	22	Reported adverse event known and documented in the labeling and all reasonable mitigation steps have been taken (including both short or long term known complications or adverse reactions).	IMDRF:D12
C91802	CDRH Cause Investigation - Investigation Conclusion Terminology	C139475	Falsified Device	Devices that deliberately and/or fraudulently misrepresent their identity, composition or source.	Falsified Device	4314	Devices that deliberately and/or fraudulently misrepresent their identity, composition or source.	IMDRF:D13
C91802	CDRH Cause Investigation - Investigation Conclusion Terminology	C91894	No Problem Detected	The device complaint or problem cannot be confirmed.	No Problem Detected	67	The device complaint or problem cannot be confirmed.	IMDRF:D14
C91802	CDRH Cause Investigation - Investigation Conclusion Terminology	C139471	Cause Not Established	The investigation findings do not lead to a clear conclusion about the cause of the reported adverse event.	Cause Not Established	4315	The investigation findings do not lead to a clear conclusion about the cause of the reported adverse event.	IMDRF:D15
C91802	CDRH Cause Investigation - Investigation Conclusion Terminology	C177435	Cause Linked to Device, No Further Information	Problems traced to the device, but the investigation could not identify the actual root cause (e.g. Design, Manufacturing, Component).	Cause linked to device but unable to trace more specifically.	44	Problems traced to the device, but the investigation could not identify the actual root cause (e.g. Design, Manufacturing, Component).	IMDRF:D1501
C91802	CDRH Cause Investigation - Investigation Conclusion Terminology	C91868	Conclusion not Yet Available	A conclusion has yet to be established as the investigation is incomplete.	Conclusion Not Yet Available	11	A conclusion has yet to be established as the investigation is incomplete. Do not use this code if the investigation is complete.	IMDRF:D16
C91802	CDRH Cause Investigation - Investigation Conclusion Terminology	C139469	Appropriate Term/Code Not Available Problem	The concluded cause is not adequately described by any other term.	Appropriate Term/Code Not Available	4316	The concluded cause is not adequately described by any other term. Note: This code must not be used unless there is no other feasible code. The preferred term should be documented when submitting an adverse event report. This information will be used to determine if a new term should be added to the code table.	IMDRF:D17
C91802	CDRH Cause Investigation - Investigation Conclusion Terminology	C177436	Cause Traced to Software Coding	Problems traced to an error, flaw or fault in a computer program or system that causes it to produce an incorrect or unexpected result, or to behave in unintended ways.	Cause Traced to Software Coding	58	Problems traced to an error, flaw or fault in a computer program or system that causes it to produce an incorrect or unexpected result, or to behave in unintended ways.	IMDRF:D18
C91802	CDRH Cause Investigation - Investigation Conclusion Terminology	C187266	Cause Traced to Artificial Intelligence Training/Validation Process	Problem traced to the process or dataset(s) used for training and/or validating artificial intelligence, including machine learning algorithms.	Cause Traced to Artificial Intelligence Training/Validation Process	4320	Problem traced to the process or dataset(s) used for training and/or validating artificial intelligence, including machine learning algorithms.	IMDRF:D19
C54450	CDRH Health Effect - Clinical Code Terminology	C122435	Impaired Balance	A deficit in equilibrium, which may manifest as unsteady ambulation or inability to maintain an upright position.	Balance Problems	4401	A feeling of falling down which can occur whether the person is standing, sitting or lying down.	IMDRF:E0101
C54450	CDRH Health Effect - Clinical Code Terminology	C50440	Brain Injury	Trauma to the brain.	Brain Injury	2219	Damage to the brain.	IMDRF:E0102
C54450	CDRH Health Effect - Clinical Code Terminology	C84687	Encephalocele	A congenital neural tube closure defect resulting in the protrusion of the brain through a skull opening. When the protrusion includes the meninges, the term encephalomeningocele is used.	Encephalocele	4402	Hernia of brain substance and meninges through a congenital or traumatic opening of the skull.	IMDRF:E010201
C54450	CDRH Health Effect - Clinical Code Terminology	C4909	Cerebral Edema	Swelling due to an excessive accumulation of fluid in the brain.	Cerebral Edema	4403	A swelling in the brain caused by the presence of excessive fluid.	IMDRF:E0103
C54450	CDRH Health Effect - Clinical Code Terminology	C171953	Cerebral Hyperperfusion Syndrome	Unexpected increase in cerebral blood flow after carotid endarterectomy or carotid artery stenting presenting with a clinical triad of ipsilateral headache, seizure and focal neurologic symptoms.	Cerebral Hyperperfusion Syndrome	4404	Unexpected increase in cerebral blood flow after carotid endarterectomy (CEA) or carotid artery stenting (CAS).	IMDRF:E0104
C54450	CDRH Health Effect - Clinical Code Terminology	C50803	Ventriculomeglia	Abnormal enlargement of the cerebral ventricles.	Cerebral Ventriculomegaly	2133	Abnormal enlargement of the cerebral ventricles.	IMDRF:E0105
C54450	CDRH Health Effect - Clinical Code Terminology	C50487	Cerebrospinal Fluid Leakage	The loss of cerebrospinal fluid into the surrounding tissues.	Cerebrospinal Fluid Leakage	1772	The loss of cerebrospinal fluid into the surrounding tissues.	IMDRF:E0106
C54450	CDRH Health Effect - Clinical Code Terminology	C50457	Alteration Of Cognitive Function	Pertaining to or characterized by cognition. That operation of the mind which we become aware of objects of thought or perception; it includes all aspects of perceiving, thinking, or remembering.	Cognitive Changes	2551	Changes in perception, thinking, or remembering.	IMDRF:E0107
C54450	CDRH Health Effect - Clinical Code Terminology	C37928	Confusion	A mental state characterized by a lack of clear and orderly thought and behavior.	Confusion/ Disorientation	2553	A mental state characterized by a lack of clear and orderly thought and behavior.	IMDRF:E010701
C54450	CDRH Health Effect - Clinical Code Terminology	C4786	Dementia	Loss of intellectual abilities interfering with an individual's social and occupational functions. Causes include Alzheimer's disease, brain injuries, brain tumors, and vascular disorders.	Dementia	4405	Loss of intellectual abilities interfering with an individual's social and occupational functions.	IMDRF:E010702
C54450	CDRH Health Effect - Clinical Code Terminology	C50502	Concussion	A violent jar or shock, or the condition which results from such an injury.	Concussion	2192	Traumatic brain injury as a result of the action of a mechanical force on the head.	IMDRF:E0108
C54450	CDRH Health Effect - Clinical Code Terminology	C2962	Seizure	Sudden, involuntary skeletal muscular contractions of cerebral or brain stem origin.	Convulsion/Seizure	4406	Sudden, involuntary skeletal muscular contractions of cerebral or brain stem origin.	IMDRF:E0109
C54450	CDRH Health Effect - Clinical Code Terminology	C50496	Clonic Convulsion	A convulsion marked by alternating contracting and relaxing of the muscles.	Convulsion, Clonic	2222	A convulsion marked by alternating contracting and relaxing of the muscles.	IMDRF:E010901
C54450	CDRH Health Effect - Clinical Code Terminology	C50776	Tonic Convulsion	Prolonged contraction of the muscles, as the result of an epileptic discharge.	Convulsion, Tonic	2223	A convulsion marked by prolonged contraction of the muscles.	IMDRF:E010902
C54450	CDRH Health Effect - Clinical Code Terminology	C3020	Seizure Disorder	A brain disorder characterized by episodes of abnormally increased neuronal discharge resulting in transient episodes of sensory or motor neurological dysfunction, or psychic dysfunction. These episodes may or may not be associated with loss of consciousness or convulsions.	Epilepsy	4407	Epilepsy caused or apparently caused by device. Do not use when epilepsy is a pre-existing condition.	IMDRF:E010903
C54450	CDRH Health Effect - Clinical Code Terminology	C85079	Status Epilepticus	A life-threatening situation in which the brain is in a continuous state of seizure.	Status Epilepticus	4408	A life-threatening condition characterised by a single prolonged seizure or a series of seizures without intervening full recovery of consciousness.	IMDRF:E010904
C54450	CDRH Health Effect - Clinical Code Terminology	C73504	Decreased Sensitivity	Lower perceptual capacity in one or more senses.	Decreased Sensitivity	2683	Lower capacity to notice through one or more senses.	IMDRF:E0110
C54450	CDRH Health Effect - Clinical Code Terminology	C73503	Increased Sensitivity	Higher perceptual capacity in one or more senses.	Increased Sensitivity	4538	Higher capacity to notice through one or more senses.	IMDRF:E0111
C54450	CDRH Health Effect - Clinical Code Terminology	C37943	Dizziness	A sensation of lightheadedness, unsteadiness, turning, spinning or rocking.	Dizziness	2194	A sensation of lightheadedness, unsteadiness, turning, spinning or rocking.	IMDRF:E0112
C54450	CDRH Health Effect - Clinical Code Terminology	C35546	Dysphasia	Impairment of verbal communication skills, often resulting from brain damage.	Dysphasia	2195	Impairment of verbal communication skills, often resulting from brain damage.	IMDRF:E0113
C54450	CDRH Health Effect - Clinical Code Terminology	C79539	Aphonia	A term referring to the inability to speak. It may result from injuries to the vocal cords or may be functional (psychogenic).	Aphonia	4409	Inability to speak.	IMDRF:E011301
C54450	CDRH Health Effect - Clinical Code Terminology	C26760	Encephalitis	An inflammatory process affecting the brain parenchyma. Causes include viral infections and less frequently bacterial infections, toxins, and immune-mediated processes.	Encephalitis	2429	An acute inflammatory process affecting the brain parenchyma.	IMDRF:E0114
C54450	CDRH Health Effect - Clinical Code Terminology	C26920	Encephalopathy	A functional and/or structural disorder of the brain caused by diseases (e.g. liver disease, kidney disease), medications, chemicals, and injuries.	Encephalopathy	1833	A functional and/or structural disorder of the brain that is acquired or congenital and characterised by mental and neurological symptoms.	IMDRF:E0115
C54450	CDRH Health Effect - Clinical Code Terminology	C34661	Headache	Pain in various parts of the head, not confined to the area of distribution of any nerve.	Headache	1880	Pain in various parts of the head, not confined to the area of distribution of any nerve.	IMDRF:E0116
C54450	CDRH Health Effect - Clinical Code Terminology	C3111	Hydrocephalus	A disorder characterized by an abnormal increase of cerebrospinal fluid in the ventricles of the brain.	Hydrocephalus	3272	A disorder characterized by an abnormal increase of cerebrospinal fluid in the ventricles of the brain.	IMDRF:E0117
C54450	CDRH Health Effect - Clinical Code Terminology	C50438	Intracranial Hemorrhage	Bleeding within the cranium.	Intracranial Hemorrhage	1891	Bleeding within the cranium.	IMDRF:E0118
C54450	CDRH Health Effect - Clinical Code Terminology	C50635	Loss of Consciousness	An inability to purposefully respond to stimuli.	Loss of consciousness	2418	A level of awareness that can be described as consistently not responsive to stimuli.	IMDRF:E0119
C54450	CDRH Health Effect - Clinical Code Terminology	C34497	Coma	A state of profound unconsciousness associated with markedly depressed cerebral activity. Causes include central nervous system damage, intoxication, and metabolic abnormalities.	Coma	2417	A state of profound unconsciousness associated with markedly depressed cerebral activity.	IMDRF:E011901
C54450	CDRH Health Effect - Clinical Code Terminology	C80100	Presyncope	An episode of lightheadedness and dizziness which may precede an episode of syncope.	Presyncope	4410	Extremely weak; threatened with syncope.	IMDRF:E011902
C54450	CDRH Health Effect - Clinical Code Terminology	C35053	Syncope	A spontaneous loss of consciousness caused by insufficient blood supply to the brain.	Syncope/Fainting	4411	A spontaneous, transient, loss of consciousness caused by insufficient blood supply to the brain.	IMDRF:E011903
C54450	CDRH Health Effect - Clinical Code Terminology	C2867	Amnesia	Systematic and extensive loss of memory caused by organic or psychological factors. The loss may be temporary or permanent, and may involve old or recent memories.	Memory Loss/Impairment	1958	Systematic and extensive loss or impairment of memory caused by organic or psychological factors. This may be temporary or permanent, and may involve old or recent memories.	IMDRF:E0120
C54450	CDRH Health Effect - Clinical Code Terminology	C26828	Meningitis	A disorder characterized by acute inflammation of the meninges of the brain and/or spinal cord.	Meningitis	2389	A disorder characterized by acute inflammation of the meninges of the brain and/or spinal cord.	IMDRF:E0121
C54450	CDRH Health Effect - Clinical Code Terminology	C116757	Movement Disorder	Neurological conditions resulting in abnormal voluntary or involuntary movement, which may impact the speed, fluency, quality and ease of movement.	Movement Disorder	4412	Neurological conditions resulting in abnormal voluntary or involuntary movement, which may impact the speed, fluency, quality and ease of movement.	IMDRF:E0122
C54450	CDRH Health Effect - Clinical Code Terminology	C50539	Dyskinesia	Abnormality or impairment of voluntary movement.	Dyskinesia	2363	Difficulty moving; distortion or impairment of voluntary movement, as in tic, spasm, or myoclonus.	IMDRF:E012201
C54450	CDRH Health Effect - Clinical Code Terminology	C3310	Paralysis	Partial or complete loss of function of one or more muscles. It is usually caused by damage to the nervous system.	Paralysis	1997	Partial or complete loss of function of one or more muscles. It is usually caused by damage to the nervous system.	IMDRF:E012202
C54450	CDRH Health Effect - Clinical Code Terminology	C50687	Paraplegia	Complete paralysis of the lower half of the body including both legs, often caused by damage to the spinal cord.	Paraplegia	2448	Paralysis of the legs and lower part of the body.	IMDRF:E012203
C54450	CDRH Health Effect - Clinical Code Terminology	C50688	Paresis	A slight or incomplete paralysis.	Paresis	1998	A slight or incomplete paralysis.	IMDRF:E012204
C54450	CDRH Health Effect - Clinical Code Terminology	C50721	Quadriplegia	Paralysis of all four limbs.	Quadriplegia	2449	Paralysis of all four limbs.	IMDRF:E012205
C54450	CDRH Health Effect - Clinical Code Terminology	C38038	Tremor	The shaking movement of the whole body or just a certain part of it, often caused by problems of the neurons responsible for muscle action.	Shaking/Tremors	2515	The shaking movement of the whole body or just a certain part of it, often caused by problems of the neurons responsible for muscle action.	IMDRF:E012206
C54450	CDRH Health Effect - Clinical Code Terminology	C50785	Twitching	The occurrence of a single contraction or a series of contractions of a muscle.	Twitching	2172	The occurrence of a single contraction or a series of contractions of a muscle.	IMDRF:E012207
C54450	CDRH Health Effect - Clinical Code Terminology	C84501	Restless Leg Syndrome	A condition that occurs while resting or lying in bed; it is characterized by an irresistible urgency to move the legs to obtain relief from a strange and uncomfortable sensation in the legs.	Restless Legs Syndrome	4584	A condition that is characterized by an irresistible urgency to move the legs to obtain relief from a strange and uncomfortable sensation in the legs.	IMDRF:E012208
C54450	CDRH Health Effect - Clinical Code Terminology	C26769	Cranial Nerve VII Palsy	Partial or complete paralysis of the facial muscles of one side of a person's face. It is caused by damage to the seventh cranial nerve. It is usually temporary but it may recur.	Facial Paralysis	4585	A partial or complete loss of function of one or more of the facial muscles resulting in paralysis of the facial regions. Includes both central and peripheral facial paralysis or palsy.	IMDRF:E012209
C54450	CDRH Health Effect - Clinical Code Terminology	C50669	Nerve Damage	Injury to nervous tissue.	Nerve Damage	1979	Injury to nervous tissue.	IMDRF:E0123
C54450	CDRH Health Effect - Clinical Code Terminology	C50849	Optic Nerve Damage	Injury to the optic nerve.	Optical Nerve Damage	1986	Injury to optical nerve.	IMDRF:E012301
C54450	CDRH Health Effect - Clinical Code Terminology	C4974	Nervous System Injury	Injury in the central or peripheral nervous system.	Nervous System Injury	2689	Injury to the central or peripheral nervous system.	IMDRF:E0124
C54450	CDRH Health Effect - Clinical Code Terminology	C50750	Spinal Cord Injury	Traumatic damage of the spinal cord.	Spinal Cord Injury	2432	Traumatic damage of the spinal cord.	IMDRF:E012401
C54450	CDRH Health Effect - Clinical Code Terminology	C79695	Neuralgia	Intense painful sensation along a nerve or group of nerves. It is caused by irritation or trauma to a nerve or inflammation of a nerve.	Neuralgia	4413	Intense painful sensation along a nerve or group of nerves.	IMDRF:E0125
C54450	CDRH Health Effect - Clinical Code Terminology	C4731	Neuropathy	A disorder affecting the cranial nerves or the peripheral nervous system. It manifests with pain, tingling, numbness, and muscle weakness. It may be the result of physical injury, toxic substances, viral diseases, diabetes, renal failure, cancer, and drugs.	Neuropathy	1983	A disorder affecting the cranial nerves or the peripheral nervous system. It manifests with pain, tingling, numbness, and muscle weakness.	IMDRF:E0126
C54450	CDRH Health Effect - Clinical Code Terminology	C34857	Numbness	A loss of the sensation of feeling in an area of the body.	Numbness	2415	The loss of the sensation of feeling in an area of the body.	IMDRF:E0127
C54450	CDRH Health Effect - Clinical Code Terminology	C101250	Peripheral Nerve Injury	Sensory or motor loss of peripheral nerve function due to a traumatic event. (ACC)	Peripheral Nervous Injury	4414	Injury to the peripheral nervous system.	IMDRF:E0128
C54450	CDRH Health Effect - Clinical Code Terminology	C50778	Tooth Sensitivity	Pain or discomfort caused by exposure of the dentin layer of tooth to thermal, tactile, or other stimuli.	Sensitivity of Teeth	2427	Pain or discomfort caused by exposure of the dentin layer of tooth to thermal, tactile, or other stimuli.	IMDRF:E0129
C54450	CDRH Health Effect - Clinical Code Terminology	C3376	Sleep Disorder	A change from the patient's baseline sleeping pattern, in the hours slept and/or an alteration/dysfunction in the stages of sleep.	Sleep Dysfunction	2517	A change from the patient's baseline sleeping pattern, in the hours slept and/or an alteration/dysfunction in the stages of sleep.	IMDRF:E0130
C54450	CDRH Health Effect - Clinical Code Terminology	C5041	Speech Disorder	A term referring to disorders characterized by the disruption of normal speech. It includes stuttering, lisps, dysarthria and voice disorders.	Speech Disorder	4415	A term referring to disorders characterized by the disruption of normal speech. It includes stuttering, lisps, dysarthria and voice disorders.	IMDRF:E0131
C54450	CDRH Health Effect - Clinical Code Terminology	C50749	Spinal Arachnoiditis	A chronic adhesive arachnoiditis in the spinal arachnoid, with root and spinal cord symptoms similar to those caused by pressure from a tumor.	Spinal Arachnoiditis	4416	A chronic adhesive arachnoiditis in the spinal arachnoid, with root and spinal cord symptoms similar to those caused by pressure from a tumor.	IMDRF:E0132
C54450	CDRH Health Effect - Clinical Code Terminology	C3390	Stroke	A sudden loss of neurological function secondary to hemorrhage or ischemia in the brain parenchyma due to a vascular event.	Stroke/CVA	1770	A sudden loss of neurological function secondary to hemorrhage or ischemia in the brain parenchyma due to a vascular event.	IMDRF:E0133
C54450	CDRH Health Effect - Clinical Code Terminology	C95803	Hemorrhagic Cerebrovascular Accident	An acute episode of focal or global cerebral or spinal dysfunction caused by intraparenchymal, intraventricular, or subarachnoid hemorrhage.	Hemorrhagic Stroke	4417	An acute neurological deficit caused by bleeding within the brain or between the brain and the skull.	IMDRF:E013301
C54450	CDRH Health Effect - Clinical Code Terminology	C95802	Ischemic Cerebrovascular Accident	An acute episode of focal cerebral, spinal, or retinal dysfunction caused by infarction of brain tissue.	Ischemia Stroke	4418	An ischemic condition of the brain, producing a persistent focal neurological deficit in the area of distribution of the cerebral arteries.	IMDRF:E013302
C54450	CDRH Health Effect - Clinical Code Terminology	C172036	Tactile Disorder	Conditions characterized by an alteration in the ability to perceive touch.	Tactile Disorders	4419	conditions characterized by an alteration in the ability to or perception of touch.	IMDRF:E0134
C54450	CDRH Health Effect - Clinical Code Terminology	C116376	Hyperesthesia	Increased sensitivity to tactile stimulation.	Hyperesthesia	4420	Increased sensitivity to tactile stimulation.	IMDRF:E013401
C54450	CDRH Health Effect - Clinical Code Terminology	C50445	Hypoesthesia	Impairment of tactile sensitivity manifesting as partial loss of sensitivity to sensory stimuli.	Hypoesthesia	2352	Impairment of tactile sensitivity manifesting as partial loss of sensitivity to sensory stimuli.	IMDRF:E013402
C54450	CDRH Health Effect - Clinical Code Terminology	C28177	Paresthesia	Abnormal cutaneous sensations of tingling, numbness, pressure, cold, and warmth that an individual experiences without the presence of a stimulus. It results from functional disturbances of sensory neurons. Causes include peripheral vascular disease, peripheral neuropathy, and nerve damage.	Paresthesia	4421	Abnormal touch sensations, such as burning or prickling, that occur without an outside stimulus.	IMDRF:E013403
C54450	CDRH Health Effect - Clinical Code Terminology	C172037	Taste Disorder	Conditions characterized by an alteration in the ability to perceive taste.	Taste Disorder	4422	Conditions characterized by an alteration in taste function or perception	IMDRF:E0135
C54450	CDRH Health Effect - Clinical Code Terminology	C116374	Ageusia	Inability to taste.	Ageusia	4423	Inability to taste.	IMDRF:E013501
C54450	CDRH Health Effect - Clinical Code Terminology	C28145	Dysgeusia	Persistence of unpleasant taste.	Dysgeusia	4424	Distortion of taste.	IMDRF:E013502
C54450	CDRH Health Effect - Clinical Code Terminology	C116725	Psychogenic Tremor	An involuntary, compulsive, repetitive stereotyped movement.	Tics/Tremor	4425	An involuntary, compulsive, repetitive stereotyped movement.	IMDRF:E0136
C54450	CDRH Health Effect - Clinical Code Terminology	C50781	Transient Ischemic Attack	A brief attack (from a few minutes to an hour) of cerebral dysfunction of vascular origin, with no persistent neurological deficit.	Transient Ischemic Attack	2109	A brief attack (from a few minutes to an hour) of cerebral dysfunction of vascular origin, with no persistent neurological deficit.	IMDRF:E0137
C54450	CDRH Health Effect - Clinical Code Terminology	C50787	Undesired Nerve Stimulation	Unintended reaction in nervous system caused by electrical stimulation.	Undesired Nerve Stimulation	1980	Unintended reaction in nerve system caused by electrical stimulation.	IMDRF:E0138
C54450	CDRH Health Effect - Clinical Code Terminology	C26835	Nervous System Disorder	A non-neoplastic or neoplastic disorder that affects the brain, spinal cord, or peripheral nerves.	Unspecified Nervous System Problem	4426	The report describes a non-specific problem with the nervous system. Note: Please use "Appropriate Term / Code Not Available" if the report describes a specific injury but the relevant term does not exist.	IMDRF:E0139
C54450	CDRH Health Effect - Clinical Code Terminology	C187268	Increased Intracranial Pressure	Pressure within the craniospinal compartment is increased.	Increased Intracranial Pressure	4586	Pressure within the craniospinal compartment is increased.	IMDRF:E0140
C54450	CDRH Health Effect - Clinical Code Terminology	C127829	Pneumocephalus	The presence of air or gas within the cranial cavity.	Pneumocephalus	4587	The presence of air or gas within the cranial cavity.	IMDRF:E0141
C54450	CDRH Health Effect - Clinical Code Terminology	C85035	Pseudotumor Cerebri	An idiopathic disorder characterized by chronic increase in the intracranial pressure. It occurs predominantly in obese females of childbearing age. It is associated with papilledema.	Idiopathic Intracranial Hypertension	4588	A condition that mimics the presence of a tumour (Pseudotumour Cerebri) or hydrocephalus, caused by chronic  increase in intracranial pressure.	IMDRF:E0142
C54450	CDRH Health Effect - Clinical Code Terminology	C121627	Altered Level of Consciousness	A level of awareness and arousal other than normal.	Altered State of Consciousness	4589	A level of awareness and arousal other than normal.	IMDRF:E0143
C54450	CDRH Health Effect - Clinical Code Terminology	C187270	Increased Level of Consciousness	A neurological state characterized by increased ability to perceive and respond.	Increased Level of Consciousness	4590	A neurological state characterised by increased ability to perceive and respond.	IMDRF:E014301
C54450	CDRH Health Effect - Clinical Code Terminology	C78253	Depressed Level Of Consciousness	A neurologic state characterized by decreased ability to perceive and respond.	Decreased Level of Consciousness	4591	A neurological state characterised by decreased ability to perceive and respond.	IMDRF:E014302
C54450	CDRH Health Effect - Clinical Code Terminology	C73511	Bruxism	Excessive clenching of the jaw and grinding of the teeth.	Bruxism	4427	Excessive clenching of the jaw and grinding of the teeth.	IMDRF:E0201
C54450	CDRH Health Effect - Clinical Code Terminology	C50489	Change in Emotional State	Change from the affected person's usual emotional state.	Emotional Changes	1831	Change from the affected person's usual emotional state.	IMDRF:E0202
C54450	CDRH Health Effect - Clinical Code Terminology	C26696	Anxiety	Apprehension of danger and dread accompanied by restlessness, tension, tachycardia, and dyspnea unattached to a clearly identifiable stimulus.	Anxiety	2328	Apprehension or uneasiness which may be accompanied by restlessness, tension, tachycardia, and dyspnea.	IMDRF:E020201
C54450	CDRH Health Effect - Clinical Code Terminology	C2982	Depression	A melancholy feeling of sadness and despair.	Depression	2361	A condition marked by ongoing feelings of sadness, despair, loss of energy, diminished interest/pleasure and difficulty dealing with normal daily life.	IMDRF:E020202
C54450	CDRH Health Effect - Clinical Code Terminology	C37942	Distress	A state of physiological or psychological stress that cannot be compensated for by normal adaptive measures.	Distress	2329	A state of physiological or psychological stress that cannot be compensated for by normal adaptive measures.	IMDRF:E020203
C54450	CDRH Health Effect - Clinical Code Terminology	C3832	Malaise	A feeling of general discomfort or uneasiness, an out-of-sorts feeling.	Malaise	2359	A feeling of general discomfort or uneasiness, an out-of-sorts feeling.	IMDRF:E020204
C54450	CDRH Health Effect - Clinical Code Terminology	C50623	Irritability	Excited response to stimuli.	Irritability	2421	A feeling of agitation. Tending to become frustrated or upset easily.	IMDRF:E020205
C54450	CDRH Health Effect - Clinical Code Terminology	C37961	Hallucination	A false sensory perception in the absence of an external stimulus, as distinct from an illusion which is a misperception of an external stimulus.	Hallucination	4428	A false sensory perception in the absence of an external stimulus.	IMDRF:E0203
C54450	CDRH Health Effect - Clinical Code Terminology	C50412	Lethargic	Characterized by a lack of vitality or energy.	Lethargy	2560	Characterized by a lack of vitality or energy.	IMDRF:E0204
C54450	CDRH Health Effect - Clinical Code Terminology	C80102	Suicidal Ideation	Thoughts of taking one's own life.	Suicidal Ideation	4429	Thoughts of taking one's own life.	IMDRF:E0205
C54450	CDRH Health Effect - Clinical Code Terminology	C172050	Unspecified Mental, Emotional or Behavioral Problem	An unspecified mental, emotional or behavioral problem.	Unspecified Mental, Emotional or Behavioural Problem	4430	The report describes a non-specific Mental, Emotional or Behavioural problem. Note: Please use "Appropriate Term / Code Not Available" if the report describes a specific problem but the relevant term does not exist.	IMDRF:E0206
C54450	CDRH Health Effect - Clinical Code Terminology	C2981	Delirium	A usually reversible condition characterized by the acute and sudden development of confusion, illusions, movement changes, inattentiveness, agitation, and hallucinations. Causes include drug abuse, poisoning, infectious processes, and fluid and electrolyte imbalance.	Delirium	4592	A usually reversible condition characterized by the acute and sudden development of confusion, illusions, movement changes, inattentiveness, agitation and hallucinations.	IMDRF:E0207
C54450	CDRH Health Effect - Clinical Code Terminology	C78576	Psychosis	A mental disorder characterized by personality change, impaired functioning, and loss of touch with reality.	Psychosis	4593	A mental disorder characterized by personality change, impaired functioning and loss of touch with reality.	IMDRF:E0208
C54450	CDRH Health Effect - Clinical Code Terminology	C2869	Anemia	A reduction in the number of red blood cells, the amount of hemoglobin, and/or the volume of packed red blood cells. Clinically, anemia represents a reduction in the oxygen-transporting capacity of a designated volume of blood, resulting from an imbalance between blood loss (through hemorrhage or hemolysis) and blood production. Signs and symptoms of anemia may include pallor of the skin and mucous membranes, shortness of breath, palpitations of the heart, soft systolic murmurs, lethargy, and fatigability.	Anemia	1706	A reduction in the number of red blood cells, the amount of hemoglobin, and/or the volume of packed red blood cells.	IMDRF:E0301
C54450	CDRH Health Effect - Clinical Code Terminology	C34376	Hemolytic Anemia	Anemia resulting from the premature destruction of the peripheral blood red cells. It may be congenital or it may be caused by infections, medications, or malignancies.	Hemolytic Anemia	2279	Anemia resulting from the premature destruction of the peripheral blood red cells.	IMDRF:E030101
C54450	CDRH Health Effect - Clinical Code Terminology	C2902	Coagulation Disorder	A condition in which there is a deviation from or interruption of the normal coagulation properties of the blood.	Coagulation Disorder	1779	A condition in which there is a deviation from or interruption of the normal coagulation properties of the blood.	IMDRF:E0302
C54450	CDRH Health Effect - Clinical Code Terminology	C2992	Disseminated Intravascular Coagulation	A pathological process where the blood starts to coagulate throughout the whole body. This depletes the body of its platelets and coagulation factors, and there is an increased risk of hemorrhage.	Disseminated Intravascular Coagulation (DIC)	1813	A pathological process where the blood starts to coagulate throughout the whole body. This depletes the body of its platelets and coagulation factors, and there is an increased risk of hemorrhage.	IMDRF:E030201
C54450	CDRH Health Effect - Clinical Code Terminology	C3408	Thrombocytopenia	A laboratory test result indicating that there is an abnormally small number of platelets in the circulating blood.	Thrombocytopenia	4431	Low blood platelet count.	IMDRF:E030202
C54450	CDRH Health Effect - Clinical Code Terminology	C37965	Hemolysis	Disruption of the integrity of the erythrocyte membrane causing release of hemoglobin.	Hemolysis	1886	Disruption of the integrity of the erythrocyte membrane causing release of hemoglobin.	IMDRF:E0303
C54450	CDRH Health Effect - Clinical Code Terminology	C50591	Hypervolemia	Too much fluid in the blood.	Hypervolemia	2664	An abnormally high circulating blood volume.	IMDRF:E0304
C54450	CDRH Health Effect - Clinical Code Terminology	C50595	Hypovolemia	Abnormally decreased volume of circulating fluid (plasma) in body.	Hypovolemia	2243	An abnormally low circulating blood volume.	IMDRF:E0305
C54450	CDRH Health Effect - Clinical Code Terminology	C3364	Septicemia	The presence of pathogenic microorganisms in the blood stream causing a rapidly progressing systemic reaction that may lead to shock. Symptoms include fever, chills, tachycardia, and increased respiratory rate. It is a medical emergency that requires urgent medical attention.	Sepsis	2067	The presence of pathogenic microorganisms in the blood stream causing a rapidly progressing systemic reaction that may lead to shock. Symptoms include fever, chills, tachycardia, and increased respiratory rate. It is a medical emergency that requires urgent medical attention.	IMDRF:E0306
C54450	CDRH Health Effect - Clinical Code Terminology	C50739	Seroma	A collection of serum in the body.	Seroma	2069	A tumor-like collection of serum in the tissues.	IMDRF:E0307
C54450	CDRH Health Effect - Clinical Code Terminology	C50765	Swollen Lymph Node	The presence of an enlarged lymph node.	Swollen Lymph Nodes/Glands	4432	The presence of an enlarged lymph node.	IMDRF:E0308
C54450	CDRH Health Effect - Clinical Code Terminology	C162110	Low Leukocyte Count	A lower than average level of leukocytes in a sample.	Low White Blood Cell Count	4433	The white blood cell count is below the normal range, including neutropenia.	IMDRF:E0309
C54450	CDRH Health Effect - Clinical Code Terminology	C171945	Blood or Lymphatic Problem	A problem with the blood or lymphatic system.	Unspecified Blood or Lymphatic problem	4434	The report describes a non-specific problem with the blood or lymphatic system. Note: Please use "Appropriate Term / Code Not Available" if the report describes a specific problem but the relevant term does not exist.	IMDRF:E0310
C54450	CDRH Health Effect - Clinical Code Terminology	C35524	Leukocytosis	A laboratory test result indicating an increased number of white blood cells in the peripheral blood.	High White Blood Cell Count	4594	The white blood cell count is above the normal range.	IMDRF:E0311
C54450	CDRH Health Effect - Clinical Code Terminology	C187274	Transfusion Reaction	Adverse events associated with the transfusion of whole blood or one of its components, most commonly a hemolytic reaction to cross-typed blood.	Transfusion Reaction	4596	Adverse events associated with the transfusion of whole blood or one of its components, most commonly a hemolytic reaction to cross-typed blood.	IMDRF:E0312
C54450	CDRH Health Effect - Clinical Code Terminology	C187275	Abnormal Blood Protein	One or more of the blood protein levels being higher or lower than normal (e.g. Albumin, C-reactive Protein).	Abnormal Blood Protein	4595	One or more of the blood protein levels being higher or lower than normal (e.g. Albumin, C-reactive Protein).	IMDRF:E0313
C54450	CDRH Health Effect - Clinical Code Terminology	C2889	Autoimmune Disease	A disorder resulting from loss of function or tissue destruction of an organ or multiple organs, arising from humoral or cellular immune responses of the individual to his own tissue constituents. It may be systemic (e.g., systemic lupus erythematosus), or organ specific, (e.g., thyroiditis).	Autoimmune Disorder	1732	A disorder resulting from loss of function or tissue destruction of an organ or multiple organs, arising from humoral or cellular immune responses of the individual to his own tissue constituents.	IMDRF:E0401
C54450	CDRH Health Effect - Clinical Code Terminology	C3114	Hypersensitivity	An immune response that occurs following exposure to an innocuous antigen, but that does not require the presence of preformed antibodies to the antigen.	Hypersensitivity/Allergic reaction	1907	A local or general reaction of an organism following contact with a specific allergen to which it has been previously exposed and to which it has become sensitized.	IMDRF:E0402
C54450	CDRH Health Effect - Clinical Code Terminology	C50460	Anaphylactic Shock	Progression of anaphylaxis into systemic shock, which is characterized by significant reduction in tissue perfusion which leads to hypoxia and hypotension, and can lead to death if untreated.	Anaphylactic Shock	1703	Progression of anaphylaxis into systemic shock, which is characterized by significant reduction in tissue perfusion which leads to hypoxia and hypotension, and can lead to death if untreated.	IMDRF:E040201
C54450	CDRH Health Effect - Clinical Code Terminology	C50410	Anaphylactoid	Resembling anaphylaxis.	Anaphylactoid	2218	Resembling anaphylaxis	IMDRF:E040202
C54450	CDRH Health Effect - Clinical Code Terminology	C50419	Local Reaction	A regionally-limited response to an antigen, which may include inflammation, induration, erythema, pruritus or pain.	Local Reaction	2035	A regionally-limited response to an antigen, which may include inflammation, induration, erythema, pruritus or pain.	IMDRF:E040203
C54450	CDRH Health Effect - Clinical Code Terminology	C3131	Immunodeficiency Syndrome	Syndromes in which there is a deficiency or defect in the mechanisms of immunity, either cellular or humoral.	Immunodeficiency	2156	A deficiency of immune response or a disorder characterized by deficient immune response.	IMDRF:E0403
C54450	CDRH Health Effect - Clinical Code Terminology	C50701	Positive Antinuclear Antibody Test	Indicates that antibodies directed against nuclear antigens have been detected.	Positive antinuclear antibodies (ANA)	2015	Indicates that antibodies directed against nuclear antigens have been detected. Almost invariably found in systemic lupus erythematosus and are frequently found in rheumatoid arthritis, scleroderma, Sjogren's Syndrome and mixed connective tissue disease.	IMDRF:E0404
C54450	CDRH Health Effect - Clinical Code Terminology	C3507	Immune System Disorder	A disorder resulting from an abnormality in the immune system.	Unspecified Immune System Problem	4435	The report describes a non-specific problem with the immune system. Note: Please use "Appropriate Term / Code Not Available" if the report describes a specific problem but the relevant term does not exist.	IMDRF:E0405
C54450	CDRH Health Effect - Clinical Code Terminology	C187286	Eye Irritation	A generic term used to describe sensations that bother the eyes like dryness, itchiness, burning and grittiness.	Eye Irritation	4803	A generic term used to describe sensations that bother the eyes like dryness, itchiness, burning and grittiness.	IMDRF:E0485
C54450	CDRH Health Effect - Clinical Code Terminology	C26693	Aneurysm	Bulging or ballooning in an area of an artery secondary to arterial wall weakening.	Aneurysm	1708	Bulging or ballooning in an area of an artery secondary to arterial wall weakening.	IMDRF:E0501
C54450	CDRH Health Effect - Clinical Code Terminology	C26999	Ruptured Aneurysm	An aneurysm that has burst, resulting in hemorrhage into adjacent tissues.	Ruptured Aneurysm	4436	An aneurysm that has burst, resulting in hemorrhage into adjacent tissues.	IMDRF:E050101
C54450	CDRH Health Effect - Clinical Code Terminology	C187276	Expanding Aneurysm	Expansion of aneurysm.	Aneurysm Expansion	4597	Expansion of aneurysm.	IMDRF:E050102
C54450	CDRH Health Effect - Clinical Code Terminology	C34398	Arteriosclerosis	A vascular disorder characterized by thickening and hardening of the walls of the arteries.	Arteriosclerosis/ Atherosclerosis	4437	A vascular disorder characterized by thickening and hardening of the walls of the arteries. Build-up of fatty material and calcium deposition in the arterial wall resulting in partial or complete occlusion of the arterial lumen.	IMDRF:E0502
C54450	CDRH Health Effect - Clinical Code Terminology	C26759	Embolism	The blockage of a blood vessel lumen by air or solid material such as blood clot or other tissues (e.g., adipose tissue, cancer cells) that have migrated from another anatomic site.	Embolism/Embolus	4438	The blockage of a blood vessel lumen by air or solid material such as blood clot or other tissues (e.g., adipose tissue, cancer cells) that have migrated from another anatomic site.	IMDRF:E0503
C54450	CDRH Health Effect - Clinical Code Terminology	C50455	Air Embolism	The presence of bubbles of air in the vascular system; occurrence is related to the entry of air into the venous circulation following trauma or surgery.	Air Embolism	1697	The presence of bubbles of air in the vascular system; occurrence is related to the entry of air into the venous circulation following trauma or surgery.	IMDRF:E050301
C54450	CDRH Health Effect - Clinical Code Terminology	C171980	Foreign Body Embolism	Occlusion of a lumen by a foreign object.	Foreign Body Embolism	4439	Type of embolism when lumen of vessel or ductus is occluded by part of device.	IMDRF:E050302
C54450	CDRH Health Effect - Clinical Code Terminology	C50713	Pulmonary Embolism	The obstruction of the pulmonary artery or one of its branches by an embolus, sometimes associated with infarction of the lung.	Pulmonary Embolism	1498	The obstruction of the pulmonary artery or one of its branches by an embolus, sometimes associated with infarction of the lung.	IMDRF:E050303
C54450	CDRH Health Effect - Clinical Code Terminology	C28195	Thromboembolism	Occlusion of the lumen of a vessel by a thrombus that has migrated from a distal site via the blood stream.	Thromboembolism	2654	Occlusion of the lumen of a vessel by a thrombus that has migrated from a distal site via the blood stream.	IMDRF:E050304
C54450	CDRH Health Effect - Clinical Code Terminology	C48198	Extravasation	The leakage of body fluid or cells from the vascular system to the surrounding tissues. This process occurs either by force or as a result of a pathologic reaction (e.g., inflammation). This process may sometimes allow cancer cells to migrate from capillaries to adjacent tissues, initiating micro-metastases.	Extravasation	1842	The leakage of body fluid or cells from the vascular system to the surrounding tissues. This process occurs either by force or as a result of a pathologic reaction (e.g., inflammation).	IMDRF:E0504
C54450	CDRH Health Effect - Clinical Code Terminology	C50579	Hematoma	A localized collection of blood, usually clotted, in an organ, space, or tissue, due to a break in the wall of a blood vessel.	Hematoma	1884	A localized collection of blood, usually clotted, in an organ, space, or tissue, due to a break in the wall of a blood vessel.	IMDRF:E0505
C54450	CDRH Health Effect - Clinical Code Terminology	C26791	Hemorrhage	The flow of blood from a ruptured blood vessel.	Hemorrhage/Blood Loss/Bleeding	1888	The loss of blood from the circulation, including blood loss from a device connected to a patient.	IMDRF:E0506
C54450	CDRH Health Effect - Clinical Code Terminology	C26758	Ecchymosis	A flat discoloration of the skin or a mucous membrane, larger in area than a petechia, caused by the extravasation of blood.	Ecchymosis	1818	A flat discoloration of the skin or a mucous membrane, larger in area than a petechia, caused by the extravasation of blood. Discolouration under the skin caused by a bleed underneath. Typically a bruise.	IMDRF:E050601
C54450	CDRH Health Effect - Clinical Code Terminology	C50856	Exsanguination	Extensive loss of blood due to internal or external hemorrhage.	Exsanguination	1841	Extensive loss of blood due to internal or external hemorrhage.	IMDRF:E050602
C54450	CDRH Health Effect - Clinical Code Terminology	C50585	High Pulmonary Arterial Wedge Pressure	The measurement of the mean left arterial pressure, as measured by a catheter introduced into the distal pulmonary artery, is high.	High Pulmonary Arterial Wedge Pressure	2480	The measurement of the mean left atrial pressure, as measured by a catheter introduced into the distal pulmonary artery, is high.	IMDRF:E0507
C54450	CDRH Health Effect - Clinical Code Terminology	C50642	Low Pulmonary Arterial Wedge Pressure	The measurement of the mean left pulmonary arterial pressure, as measured by a catheter introduced into the distal pulmonary artery, is low.	Low Pulmonary Arterial Wedge Pressure	2479	The measurement of the mean left atrial pressure, as measured by a catheter introduced into the distal pulmonary artery, is low.	IMDRF:E0508
C54450	CDRH Health Effect - Clinical Code Terminology	C34738	Ischemia	Lack of blood supply to an area of the body, resulting in impairment of tissue oxygenation.	Ischemia	1942	Lack of oxygen in tissues, commonly due to impaired blood supply to an area of the body, resulting in impairment of tissue oxygenation.	IMDRF:E0509
C54450	CDRH Health Effect - Clinical Code Terminology	C16900	Neovascularization	The formation of new or recent blood vessels. The vasculature network is critical to the development of neoplasms. As the tumor burden grows, vascular endothelial cells are recruited to form new blood vessels as an increased demand for blood and nourishment is required.	Neovascularization	1978	The formation of new blood vessels.	IMDRF:E0510
C54450	CDRH Health Effect - Clinical Code Terminology	C50804	Blood Vessel Perforation	Damage to a blood vessel resulting from a full thickness disruption in the integrity of the vessel wall.	Perforation of Vessels	2135	Damage to a blood vessel resulting from a full thickness disruption in the integrity of the vessel wall.	IMDRF:E0511
C54450	CDRH Health Effect - Clinical Code Terminology	C52352	Great Vessel Perforation	Damage to the venae cavae, pulmonary artery, pulmonary veins or aorta resulting from a full thickness disruption in the integrity of the vessel wall.	Great Vessel Perforation	2152	Damage to the venae cavae, pulmonary artery, pulmonary veins or aorta resulting from a full thickness disruption in the integrity of the vessel wall.	IMDRF:E051101
C54450	CDRH Health Effect - Clinical Code Terminology	C38003	Phlebitis	Inflammation of a vein.	Phlebitis	2004	Inflammation of a vein.	IMDRF:E0512
C54450	CDRH Health Effect - Clinical Code Terminology	C50711	Pseudoaneurysm	The creation of hematoma outside the arterial wall following bleeding due to puncture of the arterial wall. Pseudoaneurysms can also occur in the heart chambers following myocardial infarction and bleeding.	Pseudoaneurysm	2605	The creation of hematoma outside the arterial wall following bleeding due to puncture of the arterial wall. Pseudoaneurysms can also occur in the heart chambers following myocardial infarction with rupture of the wall of the ventricle.	IMDRF:E0513
C54450	CDRH Health Effect - Clinical Code Terminology	C27083	Blood Clot	An aggregation of blood factors, primarily platelets and fibrin with entrapment of cellular elements, frequently causing vascular obstruction at the point of its formation.	Thrombosis/Thrombus	4440	The formation of a blood clot in the lumen of a vessel or heart chamber.	IMDRF:E0514
C54450	CDRH Health Effect - Clinical Code Terminology	C61409	Tissue Dissection	The process of cutting apart or separating tissue, usually for further analysis or study.	Vascular Dissection	3160	Spontaneous or induced tear within the wall of a blood vessel.	IMDRF:E0515
C54450	CDRH Health Effect - Clinical Code Terminology	C40866	Vasoconstriction	Vasoconstriction involves narrowing of a blood vessel lumen due to smooth muscle contraction in the vessel wall and leads to decreased blood flow.	Vasoconstriction	2126	Vasoconstriction involves narrowing of a blood vessel lumen due to smooth muscle contraction in the vessel wall and leads to decreased blood flow.	IMDRF:E0516
C54450	CDRH Health Effect - Clinical Code Terminology	C40867	Vasodilation	Vasodilation involves widening of a blood vessel lumen due to smooth muscle relaxation in the vessel wall and leads to increased blood flow.	Vasodilatation	2127	Widening of a blood vessel lumen due to smooth muscle relaxation in the vessel wall and leads to increased blood flow.	IMDRF:E0517
C54450	CDRH Health Effect - Clinical Code Terminology	C35117	Vascular Disorder	A non-neoplastic or neoplastic disorder affecting the arteries, veins, or lymphatic vessels. Examples include vasculitis, thrombophlebitis, arteriosclerosis, lymphedema, hemangioma, and angiosarcoma.	Unspecified Vascular Problem	4441	The report describes a non-specific problem with the vascular system. Note: Please use "Appropriate Term / Code Not Available" if the report describes a specific problem but the relevant term does not exist.	IMDRF:E0518
C54450	CDRH Health Effect - Clinical Code Terminology	C187278	Reduced Blood Flow	Inadequate blood flow.	Reduced Blood Flow	4598	Inadequate blood flow to a particular area of the body.	IMDRF:E0519
C54450	CDRH Health Effect - Clinical Code Terminology	C2881	Arrhythmia	Any variation from the normal rate or rhythm (which may include the origin of the impulse and/or its subsequent propagation) in the heart.	Arrhythmia	1721	Any variation from the normal rate or rhythm (which may include the origin of the impulse and/or its subsequent propagation) in the heart.	IMDRF:E0601
C54450	CDRH Health Effect - Clinical Code Terminology	C116130	Asystole by ECG Finding	An electrocardiographic finding showing no cardiac electrical activity on the monitor or printed strip for the entire duration of the recording. (CDISC)	Asystole	4442	An electrocardiographic finding showing a state of cardiac standstill with no cardiac output and no ventricular depolarization.	IMDRF:E060101
C54450	CDRH Health Effect - Clinical Code Terminology	C50466	Atrial Fibrillation	A disorder characterized by an electrocardiographic finding of a supraventricular arrhythmia characterized by the replacement of consistent P waves by rapid oscillations or fibrillatory waves that vary in size, shape and timing and are accompanied by an irregular ventricular response. (CDISC)	Atrial Fibrillation	1729	Irregular heart rhythm, usually associated with a rapid rate, that is caused by abnormal electrical activity within the atrial.	IMDRF:E060102
C54450	CDRH Health Effect - Clinical Code Terminology	C51224	Atrial Flutter	A disorder characterized by an electrocardiographic finding of an organized, regular atrial rhythm with atrial rate of 240-340 beats per minute. Multiple P waves typically appear in the inferior leads in a saw tooth-like pattern between the QRS complexes. (CDISC)	Atrial Flutter	1730	A rapid heart rate, associated with a regular rhythm, that is caused by abnormal electrical activity within the atria.	IMDRF:E060103
C54450	CDRH Health Effect - Clinical Code Terminology	C37920	Bradycardia	An abnormally slow heart rate. Thresholds for different age, gender, and patient populations exist.	Bradycardia	1751	An abnormally slow heart rate. Thresholds for different age, gender, and patient populations exist.	IMDRF:E060104
C54450	CDRH Health Effect - Clinical Code Terminology	C171970	Ectopic Heartbeat	A cardiac beat originating from an abnormal site.	Ectopic Heartbeat	4443	A cardiac beat originating from an abnormal site. These changes lead to extra or dropped heartbeats.	IMDRF:E060105
C54450	CDRH Health Effect - Clinical Code Terminology	C34665	Heart Block by ECG Finding	An electrocardiographic finding of blocked cardiac electrical impulses along the fibers normally responsible for impulse conduction.	Heart Block	4444	An interference with the normal conduction of electrical impulses that control activity of the heart muscle.	IMDRF:E060106
C54450	CDRH Health Effect - Clinical Code Terminology	C50599	Idioventricular Rhythm	An electrocardiographic finding of three or more consecutive complexes of ventricular origin with a rate less than a certain threshold (100 or 120 beats per minute are commonly used). The QRS complexes are wide and have an abnormal morphology. (CDISC)	Idioventricular Rhythm	1923	An electrocardiographic finding of three or more consecutive complexes of ventricular origin. The QRS complexes are wide and have an abnormal morphology. (CDISC)	IMDRF:E060107
C54450	CDRH Health Effect - Clinical Code Terminology	C50622	Irregular Pulse	Not rhythmic pulse irregular in beat or accent.	Irregular Pulse	2469	A pulse that beats at irregular intervals.	IMDRF:E060108
C54450	CDRH Health Effect - Clinical Code Terminology	C38029	Tachycardia	An abnormally rapid heart rate. Thresholds for different age, gender, and patient populations exist.	Tachycardia	2095	Abnormally high heart rate. Thresholds for different age, gender, and patient populations exist.	IMDRF:E060109
C54450	CDRH Health Effect - Clinical Code Terminology	C50799	Ventricular Fibrillation	A disorder characterized by an electrocardiographic finding of a rapid grossly irregular ventricular rhythm with marked variability in QRS cycle length, morphology, and amplitude. The rate is typically greater than 300 bpm. (CDISC)	Ventricular Fibrillation	2130	Arrhythmia characterized by chaotic contractions of the ventricular muscle.	IMDRF:E060110
C54450	CDRH Health Effect - Clinical Code Terminology	C50479	Cardiac Arrest	The sudden cessation of cardiac activity in an individual who becomes unresponsive, without normal breathing and no signs of circulation. Cardiac arrest may be reversed by CPR, and/or defibrillation, cardioversion or cardiac pacing.	Cardiac Arrest	1762	The sudden cessation of productive cardiac activity in an individual who becomes unresponsive, without normal breathing and no signs of circulation.	IMDRF:E0602
C54450	CDRH Health Effect - Clinical Code Terminology	C50480	Cardiac Enzyme Elevation	An increase from the normal levels of cardiac enzymes measurement.	Cardiac Enzyme Elevation	1838	Increase from the normal levels of cardiac enzymes.	IMDRF:E0603
C54450	CDRH Health Effect - Clinical Code Terminology	C73502	Cardiac Perforation	The presence of an acquired hole in the heart. Cardiac perforation may or may not be symptomatic and may or may not be self sealing. (ACC)	Cardiac Perforation	2513	The presence of an acquired hole in the heart.	IMDRF:E0604
C54450	CDRH Health Effect - Clinical Code Terminology	C50481	Cardiac Tamponade	Acute compression of the heart caused by increased intrapericardial pressure due to the collection of blood or fluid in the pericardium from rupture of the heart, penetrating trauma, or progressive effusion.	Cardiac Tamponade	2226	Acute compression of the heart caused by increased intrapericardial pressure due to the accumulation of blood or fluid in the pericardium from rupture of the heart or great vessels, penetrating trauma, or progressive effusion.	IMDRF:E0605
C54450	CDRH Health Effect - Clinical Code Terminology	C34830	Cardiomyopathy	A disease of the heart muscle or myocardium proper. Cardiomyopathies may be classified as either primary or secondary, on the basis of etiology, or on the pathophysiology of the lesion: hypertrophic, dilated, or restrictive.	Cardiomyopathy	1764	A disease of the heart muscle.	IMDRF:E0606
C54450	CDRH Health Effect - Clinical Code Terminology	C171950	Cardiovascular Insufficiency	Circulatory insufficiency due to a decrease in the force of the cardiac contractions and/or the tone of the vascular walls.	Cardiovascular Insufficiency	4445	Circulatory insufficiency due to a decrease in the force of the cardiac contractions and / or the tone of the vascular walls	IMDRF:E0607
C54450	CDRH Health Effect - Clinical Code Terminology	C50517	Cusp Tear	A split located on a leaflet of a heart valve that prevents its complete closing, which can result in valvular dysfunction.	Cusp Tear	2656	A tear located on a leaflet of a heart valve that prevents its complete closing, which can result in valvular dysfunction.	IMDRF:E0608
C54450	CDRH Health Effect - Clinical Code Terminology	C50533	Diminished Pulse	Weak or absent palpable pulse due to decreased arterial pulse pressure.	Diminished Pulse Pressure	2606	Weak or absent palpable pulse due to decreased arterial pulse pressure.	IMDRF:E0609
C54450	CDRH Health Effect - Clinical Code Terminology	C34582	Endocarditis	Inflammation of the endocardium.	Endocarditis	1834	Inflammation of the endocardium.	IMDRF:E0610
C54450	CDRH Health Effect - Clinical Code Terminology	C3080	Congestive Heart Failure	Failure of the heart to pump a sufficient amount of blood to meet the needs of the body tissues, resulting in tissue congestion and edema. Signs and symptoms include shortness of breath, pitting edema, enlarged tender liver, engorged neck veins, and pulmonary rales.	Heart Failure/Congestive Heart Failure	4446	Inability of the heart to pump blood adequately to fill tissue metabolic requirements or the ability to do so only at an elevated filling pressure.	IMDRF:E0611
C54450	CDRH Health Effect - Clinical Code Terminology	C50625	Ischemic Heart Disease	A disorder of cardiac function caused by insufficient blood flow to the muscle tissue of the heart. The decreased blood flow may be due to narrowing of the coronary arteries, to obstruction by a thrombus, or less commonly, to diffuse narrowing of arterioles and other small vessels within the heart. Severe interruption of the blood supply to the myocardial tissue may result in necrosis of cardiac muscle (myocardial infarction).	Ischemic Heart Disease	2493	A disorder of cardiac function caused by insufficient blood flow to the muscle tissue of the heart. The decreased blood flow may be due to narrowing of the coronary arteries, to obstruction by a thrombus, or less commonly, to diffuse narrowing of arterioles and other small vessels within the heart. Severe interruption of the blood supply to the myocardial tissue may result in necrosis of cardiac muscle (myocardial infarction).	IMDRF:E0612
C54450	CDRH Health Effect - Clinical Code Terminology	C51221	Angina	Paroxysms of chest pain due to reduced oxygen to the heart.	Angina	1710	Chest pain resulting from inadequate oxygen delivery for the needs of the myocardium.	IMDRF:E061201
C54450	CDRH Health Effect - Clinical Code Terminology	C27996	Myocardial Infarction	Gross necrosis of the myocardium, as a result of interruption of the blood supply to the area, as in coronary thrombosis.	Myocardial Infarction	1969	A condition which occurs when blood flow decreases or stops to a part of the heart, causing damage to the heart muscle.	IMDRF:E061202
C54450	CDRH Health Effect - Clinical Code Terminology	C50641	Low Cardiac Output	A below normal volume of blood pumped from the right or left ventricle of the heart per unit time.	Low Cardiac Output	2501	A below normal volume of blood pumped from the right or left ventricle of the heart per unit time.	IMDRF:E0613
C54450	CDRH Health Effect - Clinical Code Terminology	C50653	Mitral Perforation	A rupture in the mitral valve tissue due to traumatic or pathologic processes.	Mitral Perforation	2512	A rupture in the mitral valve tissue due to traumatic or pathologic processes.	IMDRF:E0614
C54450	CDRH Health Effect - Clinical Code Terminology	C50661	Myocardial Contusion	A bruise to the heart.	Myocardial Contusion	1763	A bruise to the heart.	IMDRF:E0615
C54450	CDRH Health Effect - Clinical Code Terminology	C172011	Myocardial Hypertrophy	Thickening of the myocardium often due to chronic pressure overload.	Myocardial Hypertrophy	4447	Thickening of the myocardium often due to chronic pressure overload.	IMDRF:E0616
C54450	CDRH Health Effect - Clinical Code Terminology	C34831	Myocarditis	Inflammation of the muscle tissue of the heart.	Myocarditis	2470	Inflammation of the muscle tissue of the heart.	IMDRF:E0617
C54450	CDRH Health Effect - Clinical Code Terminology	C50543	Electrocardiographic Change	An electrocardiographic finding of a change in cardiac electrical activity.	Non specific EKG/ECG Changes	1817	An electrocardiographic finding of a change in cardiac electrical activity.	IMDRF:E0618
C54450	CDRH Health Effect - Clinical Code Terminology	C3319	Pericardial Effusion	Fluid collection within the pericardial sac, usually due to inflammation.	Pericardial Effusion	3271	Fluid collection within the pericardial sac, usually due to inflammation.	IMDRF:E0619
C54450	CDRH Health Effect - Clinical Code Terminology	C34915	Pericarditis	An inflammatory process affecting the pericardium.	Pericarditis	4448	Inflammation of the pericardium.	IMDRF:E0620
C54450	CDRH Health Effect - Clinical Code Terminology	C50796	Valvular Insufficiency	Dysfunction of one of the cardiac valves characterized by incomplete valve closure.	Valvular Insufficiency/ Regurgitation	4449	Dysfunction of one of the cardiac valves, with incomplete valve closure or damage to a valve leaflet resulting in valvular backflow.	IMDRF:E0621
C54450	CDRH Health Effect - Clinical Code Terminology	C51223	Aortic Valve Insufficiency	Dysfunction of the aortic valve characterized by incomplete valve closure.	Aortic Valve Insufficiency/ Regurgitation	4450	Incomplete closure or damage to a valve leaflet of the aortic valve, resulting in aortic valve backflow.	IMDRF:E062101
C54450	CDRH Health Effect - Clinical Code Terminology	C50888	Mitral Valve Insufficiency	Dysfunction of the mitral valve characterized by incomplete valve closure.	Mitral Valve Insufficiency/ Regurgitation	4451	Incomplete closure or damage to a valve leaflet of the mitral valve, resulting in mitral valve backflow.	IMDRF:E062102
C54450	CDRH Health Effect - Clinical Code Terminology	C62436	Pulmonary Valvular Insufficiency	Dysfunction of the pulmonary valve characterized by incomplete valve closure.	Pulmonary Valve Insufficiency/ Regurgitation	4452	Incomplete closure or damage to a valve leaflet of the pulmonary valve, resulting in pulmonary valve backflow.	IMDRF:E062103
C54450	CDRH Health Effect - Clinical Code Terminology	C50842	Tricuspid Valve Insufficiency	Dysfunction of the pulmonary valve characterized by incomplete valve closure.	Tricuspid Valve Insufficiency/ Regurgitation	4453	Incomplete closure or damage to a valve leaflet of the tricuspid valve, resulting in tricuspid valve backflow.	IMDRF:E062104
C54450	CDRH Health Effect - Clinical Code Terminology	C62433	Valvular Stenosis	Narrowing of the opening of one or more of the four valves of the heart.	Valvular Stenosis	2697	Obstruction of flow across a heart valve due to immobility of the leaflets and/or a restricted orifice.	IMDRF:E0622
C54450	CDRH Health Effect - Clinical Code Terminology	C50462	Aortic Valve Stenosis	Narrowing of the orifice of the aortic valve.	Aortic Valve Stenosis	1717	Obstruction of flow across a aortic heart valve due to immobility reduced elasticity of the leaflets and/or a restricted orifice.	IMDRF:E062201
C54450	CDRH Health Effect - Clinical Code Terminology	C50654	Mitral Valve Stenosis	Narrowing of the left atrioventricular mitral orifice.	Mitral Valve Stenosis	1965	Obstruction of flow across a mitral heart valve due to immobility reduced elasticity of the leaflets and/or a restricted orifice.	IMDRF:E062202
C54450	CDRH Health Effect - Clinical Code Terminology	C50715	Pulmonary Stenosis	Narrowing of the opening between the pulmonary artery and the right ventricle, usually at the level of the valve leaflets.	Pulmonary Valve Stenosis	2024	Obstruction of flow across a pulmonary heart valve due to immobility reduced elasticity of the leaflets and/or a restricted orifice.	IMDRF:E062203
C54450	CDRH Health Effect - Clinical Code Terminology	C50783	Tricuspid Valve Stenosis	Narrowing or stricture of the tricuspid orifice of the heart.	Tricuspid Valve Stenosis	2113	Obstruction of flow across a tricuspid heart valve due to immobility reduced elasticity of the leaflets and/or a restricted orifice.	IMDRF:E062204
C54450	CDRH Health Effect - Clinical Code Terminology	C3079	Heart Disorder	A non-neoplastic or neoplastic disorder that affects the heart and/or the pericardium. Representative examples include endocarditis, pericarditis, atrial myxoma, cardiac myeloid sarcoma, and pericardial malignant mesothelioma.	Unspecified Heart Problem	4454	The report describes a non-specific problem with the heart. Note: Please use "Appropriate Term / Code Not Available" if the report describes a specific problem but the relevant term does not exist.	IMDRF:E0623
C54450	CDRH Health Effect - Clinical Code Terminology	C3353	Acute Respiratory Distress Syndrome	Progressive and life-threatening pulmonary distress in the absence of an underlying pulmonary condition, usually following major trauma or surgery. Cases of neonatal respiratory distress syndrome are not included in this definition.	Adult Respiratory Distress Syndrome	1696	Progressive and life-threatening pulmonary distress in the absence of an underlying pulmonary condition, usually following major trauma or surgery. Cases of neonatal respiratory distress syndrome are not included in this definition.	IMDRF:E0701
C54450	CDRH Health Effect - Clinical Code Terminology	C50456	Airway Obstruction	Blockage of air flow in the respiratory tract.	Airway Obstruction	1699	Blockage of air flow in the respiratory tract.	IMDRF:E0702
C54450	CDRH Health Effect - Clinical Code Terminology	C26698	Apnea	Transient cessation of respiration.	Apnea	1720	Transient cessation of respiration.	IMDRF:E0703
C54450	CDRH Health Effect - Clinical Code Terminology	C28245	Aspiration, CTCAE	A disorder characterized by inhalation of solids or liquids into the lungs.	Aspiration/Inhalation	1725	The entry of foreign material past the trachea, and into the lower respiratory tract.	IMDRF:E0704
C54450	CDRH Health Effect - Clinical Code Terminology	C34932	Aspiration Pneumonitis	Inflammation of the lungs due to the inhalation of solid or liquid material.	Aspiration Pneumonitis	4455	Inflammation of the lungs due to the inhalation of solid or liquid material.	IMDRF:E0705
C54450	CDRH Health Effect - Clinical Code Terminology	C28397	Asthma	A chronic respiratory disease manifested as difficulty breathing due to the narrowing of bronchial passageways.	Asthma	1726	A chronic respiratory disease manifested as difficulty breathing due to the narrowing of bronchial passageways.	IMDRF:E0706
C54450	CDRH Health Effect - Clinical Code Terminology	C78224	Bronchial Hemorrhage	Bleeding from the bronchial wall and/or lung parenchyma.	Bronchial Hemorrhage	4456	Bleeding from the bronchial wall and/or lung parenchyma.	IMDRF:E0707
C54450	CDRH Health Effect - Clinical Code Terminology	C2911	Bronchitis	An acute or chronic inflammatory process affecting the bronchi.	Bronchitis	1752	An acute or chronic inflammatory process affecting the bronchi.	IMDRF:E0708
C54450	CDRH Health Effect - Clinical Code Terminology	C34439	Bronchospasm	Sudden contraction of the smooth muscles of the bronchial wall.	Bronchospasm	2598	Sudden contraction of the smooth muscles of the bronchial wall.	IMDRF:E0709
C54450	CDRH Health Effect - Clinical Code Terminology	C50494	Choking	Interference with respiration by compression or obstruction of the larynx or trachea.	Choking	2464	Interference with respiration by obstruction of the larynx or trachea.	IMDRF:E0710
C54450	CDRH Health Effect - Clinical Code Terminology	C3199	Chronic Obstructive Pulmonary Disease	A chronic and progressive lung disorder characterized by the loss of elasticity of the bronchial tree and the air sacs, destruction of the air sacs wall, thickening of the bronchial wall, and mucous accumulation in the bronchial tree. The pathologic changes result in the disruption of the air flow in the bronchial airways. Signs and symptoms include shortness of breath, wheezing, productive cough, and chest tightness. The two main types of chronic obstructive pulmonary disease are chronic obstructive bronchitis and emphysema.	Chronic Obstructive Pulmonary Disease (COPD)	2237	A chronic and progressive lung disorder characterized by the loss of elasticity of the bronchial tree and the air sacs, destruction of the air sacs wall, thickening of the bronchial wall, and mucous accumulation in the bronchial tree. The pathologic changes result in the disruption of the air flow in the bronchial airways. Signs and symptoms include shortness of breath, wheezing, productive cough, and chest tightness. The two main types of chronic obstructive pulmonary disease are chronic obstructive bronchitis and emphysema.	IMDRF:E0711
C54450	CDRH Health Effect - Clinical Code Terminology	C3348	Pulmonary Emphysema	A subcategory of chronic obstructive pulmonary disease (COPD). It occurs in people who smoke and suffer from chronic bronchitis. It is characterized by inflation of the alveoli, alveolar wall damage, and reduction in the number of alveoli, resulting in difficulty breathing.	Pulmonary Emphysema	1832	A condition characterized by increase beyond normal in the size of air spaces distal to the terminal bronchioles, either from dilatation of the alveoli or from destruction of their walls.	IMDRF:E071101
C54450	CDRH Health Effect - Clinical Code Terminology	C37935	Cough	A sudden, often repetitive, spasmodic contraction of the thoracic cavity, resulting in violent release of air from the lungs, and usually accompanied by a distinctive sound.	Cough	4457	A sudden, often repetitive, spasmodic contraction of the thoracic cavity, resulting in violent release of air from the lungs, and usually accompanied by a distinctive sound.	IMDRF:E0712
C54450	CDRH Health Effect - Clinical Code Terminology	C50525	Decreased Peak Expiratory Flowrate	Decreased expiratory peak flow measurement achieved during forced expiration that primarily reflects changes in upper airway conductance and may be of limited use in evaluation of changes in peripheral airway conductance. Evaluation of peak flow performance is subjective, and, therefore, acceptability criteria are lacking. Because the maneuver is effort and volume dependent, the patient must be encouraged to perform as vigorously as clinically feasible. The results of subjective evaluation may be difficult to interpret consistently. A validated dyspnea rating scale may be useful.	Decreased Peak Expiratory Flow rate	2435	Decrease in the maximum flow rate generated during a forceful exhalation, starting from full lung inflation.	IMDRF:E0713
C54450	CDRH Health Effect - Clinical Code Terminology	C50610	Increased Peak Expiratory Flowrate	An increase of the greatest rate of flow that can be achieved during forced expiration beginning with the lungs fully inflated.	Increased Peak Expiratory Flow rate	2436	An increase of the greatest rate of flow that can be achieved during forced expiration beginning with the lungs fully inflated.	IMDRF:E0714
C54450	CDRH Health Effect - Clinical Code Terminology	C50474	Bradypnea	Abnormal decrease of rate of breathing.	Decreased Respiratory Rate	2485	Abnormal decrease of rate of breathing.	IMDRF:E0715
C54450	CDRH Health Effect - Clinical Code Terminology	C50767	Tachypnea	Abnormal increase of rate of breathing.	Increased Respiratory Rate	2486	Abnormal increase of rate of breathing.	IMDRF:E0716
C54450	CDRH Health Effect - Clinical Code Terminology	C2998	Dyspnea	An uncomfortable sensation of difficulty breathing. It may present as an acute or chronic sign of an underlying respiratory or heart disorder.	Dyspnea	1816	An uncomfortable sensation of difficulty breathing. It may present as an acute or chronic sign of an underlying respiratory or heart disorder.	IMDRF:E0717
C54450	CDRH Health Effect - Clinical Code Terminology	C26766	Epistaxis	Bleeding from the nose.	Epistaxis	4458	Nose bleed.	IMDRF:E0718
C54450	CDRH Health Effect - Clinical Code Terminology	C50524	Decreased Forced Expiratory Volume	A decrease in the fraction of the forced vital capacity that is exhaled in a specific number of seconds.	Forced Expiratory Volume Decreased	2430	A decrease in the fraction of the forced vital capacity that is exhaled in a specific number of seconds.	IMDRF:E0719
C54450	CDRH Health Effect - Clinical Code Terminology	C50609	Increased Forced Expiratory Volume	An increase in the fraction of the forced vital capacity that is exhaled in a specific number of seconds.	Forced Expiratory Volume Increased	2431	An increase in the fraction of the forced vital capacity that is exhaled in a specific number of seconds.	IMDRF:E0720
C54450	CDRH Health Effect - Clinical Code Terminology	C3094	Hemoptysis	Coughing up blood from the respiratory tract.	Hemoptysis	1887	Coughing up blood from the respiratory tract.	IMDRF:E0721
C54450	CDRH Health Effect - Clinical Code Terminology	C50582	Hemothorax	A collection of blood in the pleural cavity.	Hemothorax	1896	A collection of blood in the pleural cavity.	IMDRF:E0722
C54450	CDRH Health Effect - Clinical Code Terminology	C37966	Hiccough	An involuntary contraction of the diaphragm against closed vocal cords, producing the "hic" sound.	Hiccups	1899	An involuntary contraction of the diaphragm against closed vocal cords, producing the hic sound.	IMDRF:E0723
C54450	CDRH Health Effect - Clinical Code Terminology	C50590	Hyperventilation	Abnormally prolonged, rapid, and deep breathing.	Hyperventilation	1910	Abnormally prolonged, rapid, and deep breathing.	IMDRF:E0724
C54450	CDRH Health Effect - Clinical Code Terminology	C50594	Hypoventilation	A state in which there is a reduced amount of air entering the pulmonary alveoli.	Hypoventilation	1916	A state in which there is a reduced amount of air entering the pulmonary alveoli.	IMDRF:E0725
C54450	CDRH Health Effect - Clinical Code Terminology	C3890	Hypoxia	A decrease in the amount of oxygen in the body. Symptoms range from mild (impaired judgment, memory loss, impaired motor coordination) to severe (seizures and coma).	Hypoxia	1918	A deficiency in the amount of oxygen reaching the tissues.	IMDRF:E0726
C54450	CDRH Health Effect - Clinical Code Terminology	C50645	Mediastinal Shift	Displacement of structures in the thoracic cavity in one direction due to increased pleural pressure on the contralateral side.	Mediastinal Shift	2198	Displacement of structures in the thoracic cavity in one direction due to increased pleural pressure on the contralateral side.	IMDRF:E0727
C54450	CDRH Health Effect - Clinical Code Terminology	C50662	Nasal Obstruction	Blockage of the nasal passages.	Nasal Obstruction	2466	Blockage of the nasal passages.	IMDRF:E0728
C54450	CDRH Health Effect - Clinical Code Terminology	C50644	Lung Overinflation	Abnormal permanent enlargement of the lung air spaces distal to terminal bronchiole not resulted from wall destruction, e.g. due to loss of opposite lung.	Overinflation of Lung	2397	Abnormal permanent enlargement of the lung air spaces distal to terminal bronchiole not resulted from wall destruction, e.g. due to loss of opposite lung.	IMDRF:E0729
C54450	CDRH Health Effect - Clinical Code Terminology	C26851	Pharyngitis	Inflammation of the throat most often caused by viral and bacterial infections. Other causes include allergens, chemical substances, and trauma.	Pharyngitis	2367	Inflammation of the throat most often caused by viral and bacterial infections.	IMDRF:E0730
C54450	CDRH Health Effect - Clinical Code Terminology	C3331	Pleural Effusion	Increased amounts of fluid within the pleural cavity. Symptoms include shortness of breath, cough, and chest pain. It is usually caused by lung infections, congestive heart failure, pleural and lung tumors, connective tissue disorders, and trauma.	Pleural Effusion	2010	Increased amounts of fluid within the pleural cavity. Symptoms include shortness of breath, cough, and chest pain.	IMDRF:E0731
C54450	CDRH Health Effect - Clinical Code Terminology	C34572	Empyema	An accumulation of pus in the pleural space.	Pleural Empyema	4459	An accumulation of pus in the pleural space	IMDRF:E0732
C54450	CDRH Health Effect - Clinical Code Terminology	C3333	Pneumonia	An acute, acute and chronic, or chronic inflammation focally or diffusely affecting the lung parenchyma, due to infections (viruses, fungi, mycoplasma, or bacteria), treatment (e.g. radiation), or exposure (inhalation) to chemicals. Symptoms include cough, shortness of breath, fevers, chills, chest pain, headache, sweating, and weakness.	Pneumonia	2011	An acute and/or chronic inflammation focally or diffusely affecting the lung parenchyma.	IMDRF:E0733
C54450	CDRH Health Effect - Clinical Code Terminology	C26710	Bronchopneumonia	Acute inflammation of the walls of the terminal bronchioles that spreads into the peribronchial alveoli and alveolar ducts.  It results in the creation of foci of consolidation, which are surrounded by normal parenchyma. It affects one or more lobes, and is frequently bilateral and basal.  It is usually caused by bacteria (e.g., Staphylococcus, Streptococcus, Haemophilus influenzae).  Signs and symptoms include fever, cough with production of brown-red sputum, dyspnea, and chest pain.	Bronchopneumonia	2437	Acute inflammation of the walls of the terminal bronchioles.	IMDRF:E073301
C54450	CDRH Health Effect - Clinical Code Terminology	C38006	Pneumothorax	Abnormal presence of air in the pleural cavity.	Pneumothorax	2012	Abnormal presence of air in the pleural cavity.	IMDRF:E0734
C54450	CDRH Health Effect - Clinical Code Terminology	C50712	Pulmonary Dysfunction	Impaired or abnormal functioning of the pulmonary system.	Pulmonary Dysfunction	2019	Impaired or abnormal functioning of the pulmonary system causing multiple pulmonary issues.	IMDRF:E0735
C54450	CDRH Health Effect - Clinical Code Terminology	C26868	Pulmonary Edema	Accumulation of fluid in the lung tissues causing disturbance of the gas exchange that may lead to respiratory failure. It is caused by direct injury to the lung parenchyma or congestive heart failure. The symptoms may appear suddenly or gradually. Suddenly appearing symptoms include difficulty breathing, feeling of suffocation, and coughing associated with frothy sputum. Gradually appearing symptoms include difficulty breathing while lying in bed, shortness of breath during activity, and weight gain (in patients with congestive heart failure).	Pulmonary Edema	2020	Accumulation of fluid in the lung tissues causing disturbance of the gas exchange that may lead to respiratory failure.	IMDRF:E0736
C54450	CDRH Health Effect - Clinical Code Terminology	C3120	Pulmonary Hypertension	Increased pressure within the pulmonary circulation due to lung or heart disorder.	Pulmonary Hypertension	4460	Increased pressure within the pulmonary circulation due to lung or heart disorder.	IMDRF:E0737
C54450	CDRH Health Effect - Clinical Code Terminology	C50714	Pulmonary Infarction	Localized necrosis of lung tissue caused by obstruction of the arterial blood supply, most often due to pulmonary embolism.	Pulmonary Infarction	2021	Localized necrosis of lung tissue caused by obstruction of the arterial blood supply, most often due to pulmonary embolism.	IMDRF:E0738
C54450	CDRH Health Effect - Clinical Code Terminology	C50728	Respiratory Acidosis	A condition in which the blood pH is less than normal, secondary to impaired gas exchange.	Respiratory Acidosis	2482	A condition in which the blood pH is less than normal, secondary to impaired gas exchange.	IMDRF:E0739
C54450	CDRH Health Effect - Clinical Code Terminology	C50729	Respiratory Alkalosis	A condition in which the blood pH is greater than normal, secondary to impaired gas exchange.	Respiratory Alkalosis	2483	A condition in which the blood pH is greater than normal, secondary to impaired gas exchange.	IMDRF:E0740
C54450	CDRH Health Effect - Clinical Code Terminology	C101772	Respiratory Arrest	Cessation of breathing function.	Respiratory Arrest	4461	Cessation of breathing function.	IMDRF:E0741
C54450	CDRH Health Effect - Clinical Code Terminology	C26872	Respiratory Failure	The significant impairment of gas exchange within the lungs resulting in hypoxia, hypercarbia, or both, to the extent that organ tissue perfusion is severely compromised. Causes include chronic obstructive pulmonary disease, asthma, emphysema, acute respiratory distress syndrome, pneumonia, pulmonary edema, pneumothorax, and congestive heart failure. Treatment requires intubation and mechanical ventilation until the time the lungs recover sufficient function.	Respiratory Failure	2484	The significant impairment of gas exchange within the lungs resulting in hypoxia, hypercarbia, or both, to the extent that organ tissue perfusion is severely compromised.	IMDRF:E0742
C54450	CDRH Health Effect - Clinical Code Terminology	C51447	Pulmonary Insufficiency	Impairment of gas exchange within the lungs secondary to a disease process, neoplasm, or trauma, possibly resulting in hypoxia, hypercarbia, or both, but not requiring intubation or mechanical ventilation. Patients are normally managed with pharmaceutical therapy, supplemental oxygen, or both.	Respiratory Insufficiency	4462	Impairment of gas exchange within the lungs secondary to a disease process, neoplasm, or trauma, possibly resulting in hypoxia, hypercarbia, or both.	IMDRF:E0743
C54450	CDRH Health Effect - Clinical Code Terminology	C35650	Upper Respiratory Tract Infection	An infectious process affecting the upper respiratory tract (nose, paranasal sinuses, pharynx, larynx, or trachea). Symptoms include congestion, sneezing, coughing, fever, and sore throat.	Respiratory Tract Infection	2420	An infectious disease affecting the respiratory tract.	IMDRF:E0744
C54450	CDRH Health Effect - Clinical Code Terminology	C50741	Sinus Perforation	A rupture in the sinus tissue due to traumatic or pathologic processes.	Sinus Perforation	2277	A rupture in the sinus tissue due to traumatic or pathologic processes.	IMDRF:E0745
C54450	CDRH Health Effect - Clinical Code Terminology	C50746	Sneezing	A symptom consisting of the involuntary expulsion of air from the nose.	Sneezing	2251	A symptom consisting of the involuntary expulsion of air from the nose.	IMDRF:E0746
C54450	CDRH Health Effect - Clinical Code Terminology	C50747	Sore Throat	Any kind of inflammatory process of the tonsils, pharynx, or/and larynx characterized by pain in swallowing.	Sore Throat	2396	Any kind of inflammatory process of the tonsils, pharynx, or/and larynx characterized by pain in swallowing.	IMDRF:E0747
C54450	CDRH Health Effect - Clinical Code Terminology	C50752	Stacking Breath	Condition where there are a greater number of inhalations relative to the number of exhalations.	Stacking Breaths	1593	Condition where there are a greater number of inhalations relative to the number of exhalations.	IMDRF:E0748
C54450	CDRH Health Effect - Clinical Code Terminology	C50756	Strangulation	Choking or arrest of respiration due to occlusion of the air passages; arrest of circulation in a part due to compression.	Strangulation	2084	Interference with respiration by compression of the larynx, laryngopharynx or trachea, as well as of the carotid arteria or jugular veins.	IMDRF:E0749
C54450	CDRH Health Effect - Clinical Code Terminology	C50430	Ventilator-Dependent	A condition that requires mechanical life support due to inability to breath effectively to maintain normal levels of oxygen and carbon dioxide in the body.	Ventilator Dependent	2395	A condition that requires mechanical life support due to inability to breath effectively to maintain normal levels of oxygen and carbon dioxide in the body.	IMDRF:E0750
C54450	CDRH Health Effect - Clinical Code Terminology	C78718	Wheezing	A symptom and a finding during physical examination, characterized by a high-pitched, whistling sound during breathing. It results from the narrowing or obstruction of the respiratory airways. The most common causes of wheezing are asthma, chronic obstructive pulmonary disease, tracheobronchitis, and pulmonary edema.	Wheezing	4463	A symptom and finding during physical examination, characterized by high-pitched, whistling sound during breathing. it results from narrowing or obstruction of the respiratory airways.	IMDRF:E0751
C54450	CDRH Health Effect - Clinical Code Terminology	C26871	Respiratory System Disorder	A non-neoplastic or neoplastic disorder that affects the respiratory system. Representative examples include pneumonia, chronic obstructive pulmonary disease, pulmonary failure, lung adenoma, lung carcinoma, and tracheal carcinoma.	Unspecified Respiratory Problem	4464	The report describes a non-specific problem with the respiratory system. Note: Please use "Appropriate Term / Code Not Available" if the report describes a specific problem but the relevant term does not exist.	IMDRF:E0752
C54450	CDRH Health Effect - Clinical Code Terminology	C187283	Upper Respiratory Tract Injury	Mechanical or chemical injuries to the upper airways, including trachea, pharynx and larynx.	Upper Respiratory Tract Injury	4599	Mechanical or chemical injuries to the upper airways, including trachea, pharynx and larynx.	IMDRF:E0753
C54450	CDRH Health Effect - Clinical Code Terminology	C50702	Posterior Capsular Bag Tear	A tear in the capsular bag housing the lens of the eye.	Capsular Bag Tear	2639	A tear in the capsular bag housing the lens.	IMDRF:E0801
C54450	CDRH Health Effect - Clinical Code Terminology	C26713	Cataract	Partial or complete opacity of the crystalline lens of one or both eyes that decreases visual acuity and eventually results in blindness. Some cataracts appear in infancy or in childhood, but most develop in older individuals. (Sternberg Diagnostic Surgical Pathology, 3rd ed.)	Cataract	1766	Partial or complete opacity of the crystalline lens of one or both eyes that decreases visual acuity and eventually results in blindness. Some cataracts appear in infancy or in childhood, but most develop in older individuals. (Sternberg Diagnostic Surgical Pathology, 3rd ed.)	IMDRF:E0802
C54450	CDRH Health Effect - Clinical Code Terminology	C50490	Chemosis	Edema of the mucous membrane of the eyeball and eyelid lining.	Chemosis	1775	Edema of the mucous membrane of the eyeball and eyelid lining.	IMDRF:E0803
C54450	CDRH Health Effect - Clinical Code Terminology	C34504	Conjunctivitis	Inflammation of the conjunctiva of the eye.	Conjunctivitis	1784	Inflammation of the conjunctiva of the eye.	IMDRF:E0804
C54450	CDRH Health Effect - Clinical Code Terminology	C50509	Corneal Haze	Opacity within the cornea.	Corneal Clouding/Hazing	1878	Clouding of the middle area of the cornea, usually as a result of scarring due to infection, injury, or inflammation.	IMDRF:E0805
C54450	CDRH Health Effect - Clinical Code Terminology	C50507	Corneal Decompensation	Endothelial decompensation that is manifested by opacity of the cornea. The condition often occurs as a nonspecific response to mechanical injury from incidental corneal contact by intraocular instruments during surgery; chemical injury from the improper use of intraocular drugs, drugs containing preservatives, or from residues from inadequate rinsing of detergents or other residues from surgical instruments. The most common causes of corneal endothelial decompensation in the adult population are cataract removal/IOL-related endothelial loss and Fuchs dystrophy. When severe, corneal endothelial decompensation requires corneal transplantation.	Corneal Decompensation	1790	Inability to maintain corneal integrity; or corneal edema resulting from failure of the corneal endothelium to maintain detumescence.	IMDRF:E0806
C54450	CDRH Health Effect - Clinical Code Terminology	C50508	Corneal Edema	Hazy, swollen cornea.	Corneal Edema	1791	Hazy, swollen cornea.	IMDRF:E0807
C54450	CDRH Health Effect - Clinical Code Terminology	C50859	Stromal Corneal Edema	Fluid from the aqueous humor enters the corneal stroma and causes swelling.	Corneal Stromal Edema	1824	Fluid from the aqueous humor enters the corneal stroma and causes swelling.	IMDRF:E080701
C54450	CDRH Health Effect - Clinical Code Terminology	C50901	Microcystic Corneal Edema	Corneal edema of inflammatory origin associated with contact lens wear and morphologically characterized by presence of epithelial microcysts. Microcysts are small (typically 10-50 microns in diameter), clear, irregularly shaped high refractive inclusions that form in the basal layers of the epithelium and move towards the anterior surface of the cornea, surrounding epithelial haze. The cause of microcytic edema is related to the physical presence of contact lenses and possibly a mechanical effect of lens wear.	Microcystic Edema	1823	Corneal edema of inflammatory origin associated with contact lens wear and morphologically characterized by presence of epithelial microcysts.	IMDRF:E080702
C54450	CDRH Health Effect - Clinical Code Terminology	C50549	Epithelial Microcyst	Very small, round vesicles containing fluid and cellular debris observed on the surface of the cornea under slit-lamp examination in some types of corneal dystrophy and in wearers of extended-wear lenses.	Corneal Epithelial Microcysts	4465	Very small, round vesicles containing fluid and cellular debris observed on the surface of the cornea under slit lamp examination in some types of corneal dystrophy and in wearers of extended wear lenses.	IMDRF:E0808
C54450	CDRH Health Effect - Clinical Code Terminology	C50510	Corneal Infiltration	Discrete, small lesions present in the cornea as a result of corneal inflammation and, in some cases, after soft contact lens wear especially extended-wear lenses.	Corneal Infiltrates	2231	Discrete, small lesions present in the cornea as a result of corneal inflammation and, in some cases, after soft contact lens wear especially extended-wear lenses.	IMDRF:E0809
C54450	CDRH Health Effect - Clinical Code Terminology	C50686	Pannus Formation	Superficial vascularization of the cornea with infiltration of granulation tissue; an inflammatory exudate overlying the lining layer of synovial cells on the inside of a joint.	Corneal Pannus	1447	Superficial vascularization of the cornea with infiltration of granulation tissue.	IMDRF:E0810
C54450	CDRH Health Effect - Clinical Code Terminology	C50692	Perforation of Cornea	A rupture in the corneal tissue due to traumatic or pathologic processes	Corneal Perforation	1792	A rupture in the corneal tissue due to traumatic or pathologic processes.	IMDRF:E0811
C54450	CDRH Health Effect - Clinical Code Terminology	C50511	Corneal Scar	Replacement of corneal tissue with scar tissue as a result of injury to the deeper layers of the cornea.	Corneal Scar	1793	Replacement of corneal tissue with scar tissue as a result of injury to the deeper layers of the cornea.	IMDRF:E0812
C54450	CDRH Health Effect - Clinical Code Terminology	C50513	Corneal Touch	Complications of intraocular lens surgery; usually refers to intraocular lens contact with cornea, can be intermittent or chronic.	Corneal Touch	1794	Complications of intraocular lens surgery; usually refers to intraocular lens contact with cornea, can be intermittent or chronic.	IMDRF:E0813
C54450	CDRH Health Effect - Clinical Code Terminology	C50515	Corneal Ulcer	Area of epithelial tissue loss from corneal surface; associated with inflammatory cells in the cornea and anterior chamber.	Corneal Ulcer	1796	Area of epithelial tissue loss from corneal surface; associated with inflammatory cells in the cornea and anterior chamber.	IMDRF:E0814
C54450	CDRH Health Effect - Clinical Code Terminology	C34553	Dry Eye Syndrome	A syndrome characterized by dryness of the cornea and conjunctiva. It is usually caused by a deficiency in tear production. Symptoms include a feeling of burning eyes and a possible foreign body presence in the eye.	Dry Eye(s)	1814	A syndrome characterized by dryness of the cornea and conjunctiva. It is usually caused by a deficiency in tear production. Symptoms include a feeling of burning eyes and a possible foreign body presence in the eye.	IMDRF:E0815
C54450	CDRH Health Effect - Clinical Code Terminology	C34586	Endophthalmitis	An infectious process affecting the internal structures of the eye.	Endophthalmitis	1835	Inflammation of the intraocular fluids or tissues usually with microbial organisms.	IMDRF:E0816
C54450	CDRH Health Effect - Clinical Code Terminology	C50552	Excessive Tearing	Profuse lacrimation.	Excessive Tear Production	2235	Profuse lacrimation.	IMDRF:E0817
C54450	CDRH Health Effect - Clinical Code Terminology	C45372	Eye Infection	An infectious process affecting any part of the eye. Causes include viruses and bacteria. Symptoms include itching and discomfort in the eye, watery eyes, eye pain and discharge, and blurring vision. Representative examples include pink eye, blepharitis, and trachoma.	Eye Infections	4466	An infection of any part of the eye, including the eyelid.	IMDRF:E0818
C54450	CDRH Health Effect - Clinical Code Terminology	C50617	Intraocular Infection	Infection within the eye.	Intraocular Infection	1933	Infection within the eye.	IMDRF:E081801
C54450	CDRH Health Effect - Clinical Code Terminology	C34602	Ocular Injury	Damage to the eye.	Eye Injury	1845	Damage to the eye.	IMDRF:E0819
C54450	CDRH Health Effect - Clinical Code Terminology	C26730	Corneal Abrasion	Injury to the epithelium of the cornea.	Corneal Abrasion	1789	Injury to the epithelium of the cornea.	IMDRF:E081901
C54450	CDRH Health Effect - Clinical Code Terminology	C50506	Corneal Burn	Chemical or radiant injury to the cornea.	Eye Burn	2523	Burn injury, including chemical burn, to any part of the eye.	IMDRF:E081902
C54450	CDRH Health Effect - Clinical Code Terminology	C26874	Retinal Detachment	An eye emergency condition which may lead to blindness if left untreated. It is characterized by the separation of the inner retina layers from the underlying pigment epithelium. Causes include trauma, advanced diabetes mellitus, high myopia, and choroid tumors. Symptoms include sudden appearance of floaters, sudden light flushes, and blurred vision.	Retinal Detachment	2047	Separation of the inner retina layers from the underlying pigment epithelium.	IMDRF:E081903
C54450	CDRH Health Effect - Clinical Code Terminology	C50731	Retinal Damage	Injury to the retina due to advanced age, toxicity, exposure to bright lights, or trauma.	Retinal Injury	2048	Damage to the retina due to toxicity, exposure to bright lights, or trauma.	IMDRF:E081904
C54450	CDRH Health Effect - Clinical Code Terminology	C50732	Retinal Tear	A usually small tearing of the retina occurring when the vitreous separates from the retina. It may lead to retinal detachment. Symptoms include flashes and floaters.	Retinal Tear	2050	A usually small tearing of the retina occurring when the vitreous separates from the retina. It may lead to retinal detachment.	IMDRF:E081905
C54450	CDRH Health Effect - Clinical Code Terminology	C50807	Vitreous Detachment	The separation of the vitreous from the retina.	Vitreous Detachment	2445	Detachment of the vitreous humor from the retina.	IMDRF:E081906
C54450	CDRH Health Effect - Clinical Code Terminology	C78287	Eye Pain	Painful sensation in the eye.	Eye Pain	4467	Painful sensation in the eye.	IMDRF:E0820
C54450	CDRH Health Effect - Clinical Code Terminology	C50572	Foreign Body Sensation	Feeling of grittiness or having something in the eye; frequently caused by a foreign body. Other possible causes include corneal abrasion, corneal ulcer, inturned eye lash or acute conjunctivitis.	Foreign Body Sensation in Eye	1869	Feeling of grittiness or having something in the eye; frequently caused by a foreign body.	IMDRF:E0821
C54450	CDRH Health Effect - Clinical Code Terminology	C26782	Glaucoma	Increased pressure in the eyeball due to obstruction of the outflow of aqueous humor.	Glaucoma	1875	Increased pressure in the eyeball due to obstruction of the outflow of aqueous humor.	IMDRF:E0822
C54450	CDRH Health Effect - Clinical Code Terminology	C50806	Visual Halo	Hazy ring around bright lights seen by some patients with refractive error or optical defects, e.g. cataracts, or corneal swelling.	Halo	2227	Hazy ring around bright lights seen by some patients with refractive error or optical defects, e.g. cataracts, or corneal swelling.	IMDRF:E0823
C54450	CDRH Health Effect - Clinical Code Terminology	C50592	Hyphema	Hemorrhage within the anterior chamber of the eye; bloodshot.	Hyphema	1911	Hemorrhage within the anterior chamber of the eye; bloodshot.	IMDRF:E0824
C54450	CDRH Health Effect - Clinical Code Terminology	C50593	Hypopyon	An accumulation of pus in the anterior chamber of the eye.	Hypopyon	1913	An accumulation of pus in the anterior chamber of the eye.	IMDRF:E0825
C54450	CDRH Health Effect - Clinical Code Terminology	C172147	Intraocular Pressure Decreased	Decrease of pressure of the intraocular fluid in the eye.	Intraocular Pressure Decreased	4468	Decrease of pressure of the intraocular fluid in the eye.	IMDRF:E0826
C54450	CDRH Health Effect - Clinical Code Terminology	C50618	Intraocular Pressure Increased	Increased pressure of the intraocular fluid in the eye.	Intraocular Pressure Increased	1937	Increase of pressure of the intraocular fluid in the eye.	IMDRF:E0827
C54450	CDRH Health Effect - Clinical Code Terminology	C50621	Iritis	Inflammation of the iris.	Iritis	1940	Inflammation of the iris.	IMDRF:E0828
C54450	CDRH Health Effect - Clinical Code Terminology	C26805	Keratitis	Inflammation of the cornea.	Keratitis	1944	Inflammation of the cornea.	IMDRF:E0829
C54450	CDRH Health Effect - Clinical Code Terminology	C118749	Infectious Keratitis	Inflammation of the cornea secondary to an infectious process.	Infective Keratitis	1945	Keratitis due to infection, including infection by acanthamoeba.	IMDRF:E082901
C54450	CDRH Health Effect - Clinical Code Terminology	C35468	Macular Edema	Accumulation of intraretinal fluid and protein in the macula, which may result in swelling and decreased central vision.	Macular Edema	1822	Accumulation of intraretinal fluid and protein in the macula, which may result in swelling and decreased central vision.	IMDRF:E0830
C54450	CDRH Health Effect - Clinical Code Terminology	C50504	Contact Lens Overwear Syndrome	Ocular pain which may be very intense, accompanied by corneal epithelium damage, conjunctival injection, lacrimation, blepharospasm, photophobia and hazy vision following corneal edema caused by overwear of contact lenses, principally the PMMA type.	Overwear Syndrome	2234	Ocular pain which may be very intense, accompanied by corneal epithelium damage, conjunctival injection, lacrimation, blepharospasm, photophobia and hazy vision following corneal edema caused by overwear of contact lenses, principally the PMMA type.	IMDRF:E0831
C54450	CDRH Health Effect - Clinical Code Terminology	C50716	Pupillary Block	An obstruction of the pupil.	Pupillary Block	2026	An obstruction of the pupil.	IMDRF:E0832
C54450	CDRH Health Effect - Clinical Code Terminology	C50725	Red Eye	Lay term applied to any condition with dilation of conjunctival or ciliary blood vessels; innumerable causes, especially irritation and infection.	Red Eye(s)	2038	Lay term applied to any condition with dilation of conjunctival or ciliary blood vessels; innumerable causes.	IMDRF:E0833
C54450	CDRH Health Effect - Clinical Code Terminology	C34979	Retinal Degeneration	Degeneration of the retina.	Retinal Degeneration	2049	Degeneration of the retina.	IMDRF:E0834
C54450	CDRH Health Effect - Clinical Code Terminology	C172040	Toxic Anterior Segment Syndrome	An acute postoperative inflammatory reaction in which a noninfectious substance enters the anterior segment of the eye and induces toxic damage to the intraocular tissues.	Toxic Anterior Segment Syndrome (TASS)	4469	An acute postoperative inflammatory reaction in which a noninfectious substance enters the anterior segment and induces toxic damage to the intraocular tissues.	IMDRF:E0835
C54450	CDRH Health Effect - Clinical Code Terminology	C50794	Uveitis Glaucoma and Hyphema Syndrome	Clinical triad of uveitis, glaucoma, and hyphema (UGH), especially associated with the early anterior chamber intraocular lens (IOL).Glaucoma is believed to be caused by movement of the IOL against the iris causing release of inflammatory and red blood cell debris, which obstruct the trabecular meshwork. The haptic also may cause direct damage to the trabecular meshwork contributing to the glaucoma. Incidence of UGH is dependent on both surgical methodology applied in the cataract population and type of IOL used. UGH is particularly common if metal clip lenses have been used. Components of the condition may be reversed if the offending IOL is removed before permanent damage has occurred.	UGH (Uveitis Glaucoma Hyphema) Syndrome	4470	Clinical triad of uveitis, glaucoma, and hyphema (UGH), especially associated with the insertion of an anterior chamber intraocular lens (IOL).	IMDRF:E0836
C54450	CDRH Health Effect - Clinical Code Terminology	C26909	Uveitis	An inflammatory process affecting a part of or the entire uvea. Causes include inflammatory agents (e.g., herpes simplex, herpes zoster, leptospirosis) and systemic diseases (e.g., inflammatory bowel disease, multiple sclerosis, systemic lupus erythematosus, ankylosing spondylitis). Patients present with pain and redness in the eye, light sensitivity, and blurred and decreased vision.	Uveitis	2122	Inflammation of the uvea.	IMDRF:E0837
C54450	CDRH Health Effect - Clinical Code Terminology	C50805	Visual Disturbance	An interference to normal eyesight.	Visual Disturbances	2140	An interference to normal eyesight without necessarily affecting visual acuity.	IMDRF:E0838
C54450	CDRH Health Effect - Clinical Code Terminology	C50568	Flasher	The perception of sudden or brief bursts (flashes) of light.	Flashers	1864	The perception of sudden or brief bursts of light.	IMDRF:E083801
C54450	CDRH Health Effect - Clinical Code Terminology	C50697	Phosphene Visualization	An objective visual sensation that appears with the eyes closed and in the absence of visual light.	Phosphene Visualization	2164	An objective visual sensation that appears with the eyes closed and in the absence of visual light.	IMDRF:E083802
C54450	CDRH Health Effect - Clinical Code Terminology	C50808	Vitreous Floater	Spots before the eyes caused by opaque cell fragments in the vitreous humor or lens.	Vitreous Floaters	1866	Spots or stringy shapes in vision, often caused by deposits, aggregates, or cell fragments in the vitreous humor or lens.	IMDRF:E083803
C54450	CDRH Health Effect - Clinical Code Terminology	C28210	Photophobia	Increased sensitivity of the eyes to light, which can result in the avoidance of light exposure.	Photophobia	4801	Increased sensitivity of the eyes to light causing discomfort or pain.	IMDRF:E083804
C54450	CDRH Health Effect - Clinical Code Terminology	C50602	Impaired Vision	Sight that is impaired.	Visual Impairment	2138	Decreased ability to see to a degree that requires corrective measures	IMDRF:E0839
C54450	CDRH Health Effect - Clinical Code Terminology	C27123	Blurred Vision	Blurred vision is the loss of visual acuity (sharpness of vision) resulting in a loss of ability to see small details. (from MedlinePlus Medical Encyclopedia)	Blurred Vision	2137	The loss of visual acuity (sharpness of vision).	IMDRF:E083901
C54450	CDRH Health Effect - Clinical Code Terminology	C50638	Loss of Vision	A condition in which the ability to see is impaired.	Loss of Vision	2139	Severely reduced visual acuity that cannot be corrected, or total loss of vision.	IMDRF:E083902
C54450	CDRH Health Effect - Clinical Code Terminology	C37941	Diplopia	The condition in which a single object appears as two objects. Also called "double vision." (from medterms.com)	Diplopia/Double Vision	4802	Perception of multiple images from one object.	IMDRF:E083903
C54450	CDRH Health Effect - Clinical Code Terminology	C50469	Vitreous Hemorrhage	Blood extravasation in the vitreous humor. Causes include neovascularization, retinal tear, retinal detachment, and rupture of a blood vessel aneurysm in the eye.	Vitreous Hemorrhage	2143	Blood extravasation in the vitreous humor.	IMDRF:E0840
C54450	CDRH Health Effect - Clinical Code Terminology	C50639	Loss of Vitreous Fluid	Loss or prolapse of vitreous gel.	Vitreous Loss	2142	loss or prolapse of vitreous gel.	IMDRF:E0841
C54450	CDRH Health Effect - Clinical Code Terminology	C50587	Hyalitis	Inflammatory intraocular reaction with clouding and cells in vitreous; often accompanies inflammation of ciliary body, iris, choroid, or retina.	Vitritis	2181	Inflammatory intraocular reaction with clouding and cells in vitreous; often accompanies inflammation of ciliary body, iris, choroid, or retina.	IMDRF:E0842
C54450	CDRH Health Effect - Clinical Code Terminology	C72898	Zonular Dehiscence	Rupture of the fibrous strands connecting the ciliary body and the crystalline lens of the eye.	Zonular Dehiscence	2698	Rupture of the fibrous strands connecting the ciliary body with the crystalline lens of the eye (usually at the time of cataract surgery).	IMDRF:E0843
C54450	CDRH Health Effect - Clinical Code Terminology	C172049	Unspecified Eye/Vision Problem	A unspecified problem with the eye(s) or vision.	Unspecified Eye / Vision Problem	4471	The report describes a non-specific problem with the eye(s) or vision. Note: Please use "Appropriate Term / Code Not Available" if the report describes a specific problem but the relevant term does not exist.	IMDRF:E0844
C54450	CDRH Health Effect - Clinical Code Terminology	C187287	Corneal Thinning	Progressive deformation of the corneal structure, characterized by thinning of the cornea.	Corneal Thinning	4804	Progressive deformation of the corneal structure, characterized by thinning of the cornea.	IMDRF:E0846
C54450	CDRH Health Effect - Clinical Code Terminology	C187288	Pigment Dispersion Syndrome	Condition where iris pigment is released into the anterior chamber and deposited in the trabecular meshwork, due to a procedure or device implantation.	Pigment Dispersion Syndrome	4805	Condition where iris pigment is released into the anterior chamber and deposited in the trabecular meshwork, due to a procedure or device implantation.	IMDRF:E0847
C54450	CDRH Health Effect - Clinical Code Terminology	C187360	Corneal Endothelial Cell Loss	A decrease in corneal endothelial cell density.	Corneal Endothelial Cell Loss	4806	Decrease in corneal endothelial cell density.	IMDRF:E0848
C54450	CDRH Health Effect - Clinical Code Terminology	C187361	Posterior Capsule Opacification	Remnant lens epithelial cell proliferation and migration to the posterior capsule.	Posterior Capsule Opacification	4807	Remnant lens epithelial cell proliferation and migration to the posterior capsule.	IMDRF:E0849
C54450	CDRH Health Effect - Clinical Code Terminology	C26728	Conjunctival Hemorrhage	A hemorrhage occurring in the conjunctiva of the eye.	Conjunctival Hemorrhage	4808	Blood extravasation in the conjunctiva.	IMDRF:E0850
C54450	CDRH Health Effect - Clinical Code Terminology	C187279	Retinal Hemorrhage	Blood extravasation in the retina.	Retinal Hemorrhage	4809	Blood extravasation in the retina.	IMDRF:E0851
C54450	CDRH Health Effect - Clinical Code Terminology	C187280	Choroidal Hemorrhage	Blood extravasation in the choroid.	Choroidal Hemorrhage	4810	Blood extravasation in the choroid.	IMDRF:E0852
C54450	CDRH Health Effect - Clinical Code Terminology	C187281	Optic Nerve Sheath Hemorrhage	Blood extravasation in the optic nerve sheath.	Optic Nerve Sheath Hemorrhage	4811	Blood extravasation in the Optic Nerve Sheath.	IMDRF:E0853
C54450	CDRH Health Effect - Clinical Code Terminology	C50452	Acoustic Shock	Neurophysiological and psychological symptoms caused by sudden and unexpected loud noise.	Acoustic Shock	1693	Neurophysiological and psychological symptoms caused by sudden and unexpected loud noise.	IMDRF:E0901
C54450	CDRH Health Effect - Clinical Code Terminology	C50453	Acoustic Trauma	Injury to the hearing mechanisms within the inner ear, caused by excessively loud noise.	Acoustic Trauma	1694	Injury to the hearing mechanisms within the inner ear, caused by excessively loud noise.	IMDRF:E0902
C54450	CDRH Health Effect - Clinical Code Terminology	C50576	Hearing Impairment	Partial or complete loss of the ability to detect or understand sounds resulting from damage to the outer, middle, or inner ear structures. Causes include exposure to loud noise, ear infections, injuries to the ear, genetic, and congenital disorders.	Hearing Impairment	1881	Partial or complete loss of the ability to detect or understand sounds resulting from damage to the outer, middle, or inner ear structures.	IMDRF:E0903
C54450	CDRH Health Effect - Clinical Code Terminology	C27643	Partial Hearing Loss	A condition in which a person partially loses the ability to hear sounds in one or both ears.	Partial Hearing Loss	4472	A condition in which a person partially loses the ability to hear sounds in one or both ears.	IMDRF:E090301
C54450	CDRH Health Effect - Clinical Code Terminology	C36194	Complete Deafness	Total inability to hear sounds in one or both ears.	Total Hearing Loss	4473	A condition in which a person completely loses the hearing in one or both ears.	IMDRF:E090302
C54450	CDRH Health Effect - Clinical Code Terminology	C50772	Tinnitus	Abnormal perception of sounds experienced by an individual in the absence of auditory stimulation.	Tinnitus	2103	A noise in the ears, such as ringing, buzzing, roaring or clicking in the absence of auditory stimulation.	IMDRF:E0904
C54450	CDRH Health Effect - Clinical Code Terminology	C38057	Vertigo	A feeling of movement, a sensation as if the external world were revolving around the patient (objective vertigo) or as if he himself were revolving in space (subjective vertigo). Vertigo is medically distinct from dizziness, lightheadedness, and unsteadiness.	Vertigo	2134	A feeling of movement, a sensation as if the external world were revolving around the person or as if they were revolving in space (subjective vertigo). Vertigo is medically distinct from dizziness, lightheadedness, and unsteadiness.	IMDRF:E0905
C54450	CDRH Health Effect - Clinical Code Terminology	C171969	Ear or Labyrinth Problem	A non-specific problem with the ear or labyrinth.	Unspecified Ear or Labyrinth Problem	4474	The report describes a non-specific problem with the ear or labyrinth. Note: Please use "Appropriate Term / Code Not Available" if the report describes a specific problem but the relevant term does not exist.	IMDRF:E0906
C54450	CDRH Health Effect - Clinical Code Terminology	C37944	Ear Pain	Painful sensation in the ear region.	Ear Pain	4812	Earache or ear pain.	IMDRF:E0907
C54450	CDRH Health Effect - Clinical Code Terminology	C27193	Ear Infection	A viral or bacterial infection that affects the external, middle, or inner ear.  It may follow an upper respiratory infection.  Signs and symptoms include pain, ear discharge, ear fullness, hearing loss, vertigo, nausea, and vomiting.	Ear Infection	4813	Infection of the ear.	IMDRF:E0908
C54450	CDRH Health Effect - Clinical Code Terminology	C3299	Infectious Otitis Externa	Inflammation of the anatomical structures of the outer ear and ear canal secondary to an infectious process. Bacterial etiology is most common, but fungal infection is also possible. Symptoms include erythema, edema, and pain.	Otitis Externa	4814	An infectious process involving the outer ear and ear canal.	IMDRF:E090801
C54450	CDRH Health Effect - Clinical Code Terminology	C34885	Otitis Media	Inflammation of the anatomical structures of the middle ear, which is most often caused by an infectious process. Symptoms include erythema and edema of the tympanic membrane, pain, and possibly fever.	Middle Ear Inflammation	4816	Inflammation (swelling and redness) to the middle ear.	IMDRF:E0909
C54450	CDRH Health Effect - Clinical Code Terminology	C128369	Labyrinthitis	Inflammation of the anatomical structures of the inner ear secondary to an infectious process. Symptoms include severe vertigo, nausea, vomiting, anxiety, and pain. Viral etiology is most common, and recent history of an upper respiratory infection is common.	Labyrinthitis	4817	An inflammation of the labyrinth in the inner ear that causes dizziness and reduced or distorted hearing.	IMDRF:E0910
C54450	CDRH Health Effect - Clinical Code Terminology	C78161	Abdominal Distension	Swelling of the abdomen resulting from excessive food intake, malnutrition, liver disease, primary abdominal tumors, and tumors metastatic to the abdominal cavity.	Abdominal Distention	2601	The condition of the abdomen being enlarged or swollen from internal pressure.	IMDRF:E1001
C54450	CDRH Health Effect - Clinical Code Terminology	C26682	Abdominal Pain	Painful sensation in the abdominal region.	Abdominal Pain	1685	Painful sensation in the abdominal region.	IMDRF:E1002
C54450	CDRH Health Effect - Clinical Code Terminology	C50451	Achalasia	Failure of the smooth muscle fibers of the gastrointestinal tract to relax at any one point of junction of one part with another.	Achalasia	1692	Failure of the smooth muscle fibers of the gastrointestinal tract to relax at any one point of junction of one part with another.	IMDRF:E1003
C54450	CDRH Health Effect - Clinical Code Terminology	C2885	Ascites	The accumulation of fluid in the peritoneal cavity, which may be serous, hemorrhagic, or the result of tumor metastasis to the peritoneum.	Ascites	2596	Accumulation of fluid in the peritoneal cavity. The fluid may be serous, hemorrhagic, or the result of tumor metastasis to the peritoneum.	IMDRF:E1004
C54450	CDRH Health Effect - Clinical Code Terminology	C50473	Bowel Burn	A thermal, chemical or radiation injury to the bowels.	Bowel Burn	1756	A thermal injury to the bowels.	IMDRF:E1005
C54450	CDRH Health Effect - Clinical Code Terminology	C39611	Intestinal Perforation	A rupture in the wall of the small or large intestine due to traumatic or pathologic processes.	Bowel Perforation	2668	A rupture in the wall of the small or large intestine due to traumatic or pathologic processes.	IMDRF:E1006
C54450	CDRH Health Effect - Clinical Code Terminology	C37930	Constipation	Irregular and infrequent or difficult evacuation of the bowels.	Constipation	3274	Irregular and infrequent or difficult evacuation of the bowels.	IMDRF:E1007
C54450	CDRH Health Effect - Clinical Code Terminology	C2987	Diarrhea	Watery bowel movements.	Diarrhea	1811	Frequent, watery bowel movements.	IMDRF:E1008
C54450	CDRH Health Effect - Clinical Code Terminology	C2980	Dysphagia	A symptom referring to difficulty in swallowing. It may be observed in patients with stroke, motor neuron disorders, cancer of the throat or mouth, head and neck injuries, Parkinson disease, and multiple sclerosis.	Dysphagia/ Odynophagia	1815	A symptom referring to difficult and or painful swallowing.	IMDRF:E1009
C54450	CDRH Health Effect - Clinical Code Terminology	C50550	Eructation	To belch, the casting of upwind from the stomach.	Eructate	1839	To belch, the casting of upwind from the stomach.	IMDRF:E1010
C54450	CDRH Health Effect - Clinical Code Terminology	C50569	Flatus	Gas or air in the gastrointestinal tract.	Flatus	1865	Gas or air in the gastrointestinal tract.	IMDRF:E1011
C54450	CDRH Health Effect - Clinical Code Terminology	C26780	Gastritis	Inflammation of the stomach.	Gastritis	1874	Inflammation of the stomach.	IMDRF:E1012
C54450	CDRH Health Effect - Clinical Code Terminology	C171982	Gastroesophageal Burn	A thermal, chemical or radiation injury to the stomach or esophagus.	Gastroesophageal Burn	4475	Thermal, chemical or radiation injury to stomach or esophagus.	IMDRF:E1013
C54450	CDRH Health Effect - Clinical Code Terminology	C48592	Gastrointestinal Hemorrhage	Bleeding originating from any part of the gastrointestinal tract.	Gastrointestinal Hemorrhage	4476	Bleeding originating from any part of the gastrointestinal tract.	IMDRF:E1014
C54450	CDRH Health Effect - Clinical Code Terminology	C92560	Gastroesophageal Reflux	The backward flow of stomach acid contents into the esophagus (the tube that connects the mouth to the stomach).	Gastrointestinal Regurgitation	4477	Flow in the opposite direction from normal, as the casting up of undigested food or gas from the stomach, or the backward flowing of blood into the heart, or between the chambers of the heart when a valve is incompetent.	IMDRF:E1015
C54450	CDRH Health Effect - Clinical Code Terminology	C37964	Hematemesis	Vomiting blood.	Hematemesis	4478	Vomiting blood.	IMDRF:E1016
C54450	CDRH Health Effect - Clinical Code Terminology	C78372	Intra-Abdominal Hemorrhage	Bleeding within the abdominal cavity.	Intra-Abdominal Hemorrhage	4479	Bleeding within the abdominal cavity.	IMDRF:E1017
C54450	CDRH Health Effect - Clinical Code Terminology	C50841	Laceration Of Esophagus	A torn, ragged, mangled wound, or an accidental cut of esophagus.	Laceration(s) of Esophagus	2398	A torn, ragged, mangled wound, or an accidental cut of esophagus.	IMDRF:E1018
C54450	CDRH Health Effect - Clinical Code Terminology	C86571	Melena	Abnormally dark tarry feces containing blood, usually from gastrointestinal bleeding.	Melena	4480	Abnormally dark tarry feces containing blood, usually from gastrointestinal bleeding.	IMDRF:E1019
C54450	CDRH Health Effect - Clinical Code Terminology	C3258	Nausea	Upper abdominal discomfort associated with an urge to vomit.	Nausea	1970	Upper abdominal discomfort associated with an urge to vomit.	IMDRF:E1020
C54450	CDRH Health Effect - Clinical Code Terminology	C3306	Pancreatitis	Inflammation of the pancreas.	Pancreatitis	4481	Inflammation of the pancreas.	IMDRF:E1021
C54450	CDRH Health Effect - Clinical Code Terminology	C50693	Esophageal Perforation	The presence of a hole or other type of opening in the esophageal wall through which the contents of the esophagus can pass into the mediastinum. The most common cause of esophageal perforation is injury during a medical procedure such as esophagoscopy or placement of a naso-gastric tube; and pathologic process such as neoplasm or gastric reflux with ulceration. Less common causes include injuries from penetrating or blunt trauma or injury to the esophagus during an operation on another organ, mechanical problem such as violent retching or vomiting; ingestion of a foreign body or caustic agents. The condition often results in infection of the mediastinum and mediastinitis.	Perforation of Esophagus	2399	The presence of a hole or other type of opening in the esophageal wall through which the contents of the esophagus can pass into the mediastinum.	IMDRF:E1022
C54450	CDRH Health Effect - Clinical Code Terminology	C50695	Peritoneal Laceration	A cut or tear of the peritoneum.	Peritoneal Laceration(s)	2003	A cut or tear of the peritoneum.	IMDRF:E1023
C54450	CDRH Health Effect - Clinical Code Terminology	C26849	Peritonitis	Inflammation of the peritoneum due to infection by bacteria or fungi. Causes include liver disease, perforation of the gastrointestinal tract or biliary tract, and peritoneal dialysis. Patients usually present with abdominal pain and tenderness, fever, chills, and nausea and vomiting. It is an emergency medical condition that requires prompt medical attention and treatment.	Peritonitis	2252	Inflammation of the peritoneum due to infection by bacteria or fungi.	IMDRF:E1024
C54450	CDRH Health Effect - Clinical Code Terminology	C34670	Heartburn	Abdominal discomfort with retrosternal pain usually associated with gastroesophageal reflux.	Heartburn/Indigestion	1883	Abdominal discomfort with retrosternal pain usually associated with gastroesophageal reflux, pyrosis or dyspepsia.	IMDRF:E1025
C54450	CDRH Health Effect - Clinical Code Terminology	C78583	Rectal Anastomotic Leakage	Leakage due to breakdown of a rectal anastomosis.	Rectal Anastomotic Leakage	4482	Leakage due to breakdown of a rectal anastomosis.	IMDRF:E1026
C54450	CDRH Health Effect - Clinical Code Terminology	C26944	Retroperitoneal Hemorrhage	Bleeding originating in the retroperitoneal area.	Retroperitoneal Hemorrhage	4483	Bleeding originating in the retroperitoneal area.	IMDRF:E1027
C54450	CDRH Health Effect - Clinical Code Terminology	C26879	Salivary Gland Disorder	A non-neoplastic or neoplastic (benign or malignant) disorder involving a salivary gland.	Salivary Gland Problem	4484	A non-neoplastic or neoplastic (benign or malignant) disorder involving a salivary gland.	IMDRF:E1028
C54450	CDRH Health Effect - Clinical Code Terminology	C26917	Xerostomia	Dryness of the oral mucosa secondary to a decrease in saliva production, or a change in saliva composition.	Dry Mouth	4485	The condition of not having enough saliva to keep the mouth moist.	IMDRF:E102801
C54450	CDRH Health Effect - Clinical Code Terminology	C172030	Salivary Hypersecretion	Excessive saliva production.	Salivary Hypersecretion	4486	Excessive saliva production.	IMDRF:E102802
C54450	CDRH Health Effect - Clinical Code Terminology	C34595	Esophageal Stricture	Narrowing of the lumen of the esophagus.	Stenosis of the esophagus	4487	Narrowing or tightening of the esophagus	IMDRF:E1029
C54450	CDRH Health Effect - Clinical Code Terminology	C3388	Gastric Ulcer	An ulcerated lesion in the mucosal surface of the stomach. It may progress to involve the deeper layers of the gastric wall.	Stomach Ulceration	4488	The formation of sores or a break in the wall of the stomach.	IMDRF:E1030
C54450	CDRH Health Effect - Clinical Code Terminology	C26887	Stomatitis	Inflammation of the oral mucosa due to local or systemic factors.	Stomatitis	4489	Inflammation of the oral mucosa.	IMDRF:E1031
C54450	CDRH Health Effect - Clinical Code Terminology	C112199	Glossitis	Inflammation of the tongue.	Glossitis	4490	Inflammation of the tongue.	IMDRF:E103101
C54450	CDRH Health Effect - Clinical Code Terminology	C3442	Vomiting	Forceful ejection of the contents of the stomach through the mouth.	Vomiting	2144	Forceful ejection of the contents of the stomach through the mouth.	IMDRF:E1032
C54450	CDRH Health Effect - Clinical Code Terminology	C2990	Digestive System Disorder	A non-neoplastic or neoplastic disorder that affects the gastrointestinal tract, anus, liver, biliary system, and pancreas.	Unspecified Gastrointestinal Problem	4491	The report describes a non-specific problem with the gastrointestinal system. Note: Please use "Appropriate Term / Code Not Available" if the report describes a specific problem but the relevant term does not exist.	IMDRF:E1033
C54450	CDRH Health Effect - Clinical Code Terminology	C187363	Fecal Urgency	A continual or recurrent inclination to evacuate the bowels.	Fecal Urgency	4818	A continual or recurrent inclination to evacuate the bowels.	IMDRF:E1034
C54450	CDRH Health Effect - Clinical Code Terminology	C99012	Pneumoperitoneum	Free air within the peritoneal cavity.	Pneumoperitoneum	4819	Free air within the peritoneal cavity.	IMDRF:E1035
C54450	CDRH Health Effect - Clinical Code Terminology	C51225	Biliary Cirrhosis	Cirrhosis of the liver caused either by destruction of the intrahepatic bile ducts (primary biliary cirrhosis) or blockage of the extrahepatic bile ducts (secondary biliary cirrhosis).	Biliary Cirrhosis	1736	Cirrhosis of the liver caused either by destruction of the intrahepatic bile ducts (primary biliary cholangitis) or blockage of the extrahepatic bile ducts (secondary biliary cholangitis).	IMDRF:E1101
C54450	CDRH Health Effect - Clinical Code Terminology	C3095	Hepatitis	Inflammation of the liver; usually from a viral infection, but sometimes from toxic agents.	Hepatitis	1897	Inflammation of the liver; usually from a viral infection, but sometimes from toxic agents.	IMDRF:E1102
C54450	CDRH Health Effect - Clinical Code Terminology	C27088	Hyperbilirubinemia	Abnormally high level of bilirubin in the blood. Excess bilirubin is associated with jaundice.	Hyperbilirubinemia	1903	Abnormally high level of bilirubin in the blood. Excess bilirubin is associated with jaundice.	IMDRF:E1103
C54450	CDRH Health Effect - Clinical Code Terminology	C50634	Liver Dysfunction	A finding that indicates abnormal liver function.	Liver Damage/Dysfunction	1954	Non traumatic damage to the liver parenchyma resulting in hepatic insufficiency.	IMDRF:E1104
C54450	CDRH Health Effect - Clinical Code Terminology	C26922	Liver Failure	A disorder characterized by the inability of the liver to metabolize chemicals in the body. Causes include cirrhosis and drug-induced hepatotoxicity. Signs and symptoms include jaundice and encephalopathy. Laboratory test results reveal abnormal plasma levels of ammonia, bilirubin, lactic dehydrogenase, and alkaline phosphatase.	Liver Failure	4492	Sustained, and severe damage to the liver with significant loss of function.	IMDRF:E1105
C54450	CDRH Health Effect - Clinical Code Terminology	C50854	Liver Laceration	A cut or tear in the liver.	Liver Laceration(s)	1955	A cut or tear in the liver.	IMDRF:E1106
C54450	CDRH Health Effect - Clinical Code Terminology	C171986	Hepatic or Biliary Problem	A non-specific problem with the liver or biliary system.	Unspecified Hepatic or Biliary Problem	4493	The report describes a non-specific problem with the liver or biliary system. Note: Please use "Appropriate Term / Code Not Available" if the report describes a specific problem but the relevant term does not exist.	IMDRF:E1107
C54450	CDRH Health Effect - Clinical Code Terminology	C187364	Biliary Leak	Sudden unexpected leakage of bile from the liver or soft tissue.	Biliary Leak	4820	Sudden unexpected leakage of bile from the liver or soft tissue.	IMDRF:E1108
C54450	CDRH Health Effect - Clinical Code Terminology	C26718	Cholangitis	An acute or chronic inflammatory process affecting the biliary tract.	Cholangitis	4821	Inflammation of the bile duct.	IMDRF:E1109
C54450	CDRH Health Effect - Clinical Code Terminology	C26740	Dehydration	A condition resulting from the excessive loss of water from the body. It is usually caused by severe diarrhea, vomiting or diaphoresis.	Dehydration	1807	A condition resulting from the excessive loss of fluid from the body.	IMDRF:E1201
C54450	CDRH Health Effect - Clinical Code Terminology	C50545	Electrolyte Imbalance	Higher or lower than normal values for the serum electrolytes; usually affecting NA, K, CHL, CO2, glucose, bun.	Electrolyte Imbalance	2196	Higher or lower than normal values for the serum electrolytes; usually affecting Na, K, Cl, Ca, CO2, BUN.	IMDRF:E1202
C54450	CDRH Health Effect - Clinical Code Terminology	C37970	Hypernatremia	Higher than normal levels of sodium in the circulating blood.	Hypernatremia	2242	Higher than normal levels of sodium in the circulating blood.	IMDRF:E120201
C54450	CDRH Health Effect - Clinical Code Terminology	C37976	Hyponatremia	Lower than normal levels of sodium in the circulating blood.	Hyponatremia	4494	Lower than normal levels of sodium in the circulating blood.	IMDRF:E120202
C54450	CDRH Health Effect - Clinical Code Terminology	C3112	Hypercalcemia	Abnormally high concentration of calcium in the peripheral blood.	Hypercalcemia	4822	Higher than normal levels of calcium in the circulating blood.	IMDRF:E120203
C54450	CDRH Health Effect - Clinical Code Terminology	C37973	Hypocalcemia	Lower than normal levels of calcium in the circulating blood.	Hypocalcemia	4823	Lower than normal levels of calcium in the circulating blood.	IMDRF:E120204
C54450	CDRH Health Effect - Clinical Code Terminology	C37968	Hyperkalemia	Higher than normal levels of potassium in the circulating blood; associated with kidney failure or sometimes with the use of diuretic drugs.	Hyperkalemia	4824	Higher than normal levels of potassium in the circulating blood.	IMDRF:E120205
C54450	CDRH Health Effect - Clinical Code Terminology	C37974	Hypokalemia	Lower than normal levels of potassium in the circulating blood.	Hypokalemia	4825	Lower than normal levels of potassium in the circulating blood.	IMDRF:E120206
C54450	CDRH Health Effect - Clinical Code Terminology	C187367	Blood Bicarbonate Increased	Higher than normal levels of bicarbonate in the blood.	Blood Bicarbonate Increased	4826	Higher than normal levels of bicarbonate in the blood.	IMDRF:E120207
C54450	CDRH Health Effect - Clinical Code Terminology	C78181	Serum Bicarbonate Decreased	A laboratory test result which indicates decreased levels of bicarbonate in the serum.	Blood Bicarbonate Decreased	4827	Lower than normal levels of bicarbonate in the blood.	IMDRF:E120208
C54450	CDRH Health Effect - Clinical Code Terminology	C113750	Hyperphosphatemia	Abnormally high level of phosphate in the blood.	Hyperphosphatemia	4828	Higher than normal levels of phosphate in the circulating blood.	IMDRF:E120209
C54450	CDRH Health Effect - Clinical Code Terminology	C50560	Feeding Problem	Interruption or disruption of the intake of food/nutrition.	Feeding Problem	1850	Interruption or disruption of the intake of food/nutrition.	IMDRF:E1203
C54450	CDRH Health Effect - Clinical Code Terminology	C3109	Hot Flashes	A temporary feeling of intense body warmth, flushing, sometimes accompanied by sweating. A common, symptom of menopause; other conditions that can produce hot flushes include antidepressants and drugs blocking the effect of estrogens, carcinoid tumors and a sensitivity to sulfites or other food additives.	Hot Flashes/Flushes	2153	A temporary and/or sudden feeling of intense body warmth, flushing, sometimes accompanied by sweating.	IMDRF:E1204
C54450	CDRH Health Effect - Clinical Code Terminology	C26797	Hyperglycemia	Abnormally high level of glucose in the blood.	Hyperglycemia	1905	Abnormally high level of glucose in the blood.	IMDRF:E1205
C54450	CDRH Health Effect - Clinical Code Terminology	C50530	Diabetic Ketoacidosis	The metabolic condition resulted from uncontrolled diabetes mellitus, in which the shift of acid-base status of the body toward the acid side because of loss of base or retention of acids other than carbonic acid is accompanied by the accumulation of ketone bodies in body tissues and fluids.	Elevated Ketones/Diabetic Ketoacidosis	2364	Elevated ketones, including metabolic acidosis produced by accumulation of ketone bodies resulting from uncontrolled diabetes mellitus.	IMDRF:E120501
C54450	CDRH Health Effect - Clinical Code Terminology	C3126	Hypoglycemia	Abnormally low level of glucose in the blood.	Hypoglycemia	1912	Abnormally low level of glucose in the blood.	IMDRF:E1206
C54450	CDRH Health Effect - Clinical Code Terminology	C50700	Polydipsia	Chronic excessive intake of water; it may be from an organic cause, such as the dehydration of diabetes mellitus, diabetes insipidus, or a reaction to medication, or from a psychological cause. When untreated it can lead to water intoxication.	Polydipsia	2604	Extreme thirst accompanied by chronic excessive intake of water.	IMDRF:E1207
C54450	CDRH Health Effect - Clinical Code Terminology	C50810	Weight Fluctuation	Repetitive loss and regain of body weight.	Weight Changes	2607	Repetitive loss and regain of body weight.	IMDRF:E1208
C54450	CDRH Health Effect - Clinical Code Terminology	C92809	Hormone Imbalance	An abnormal finding indicating that the level of a particular hormone is not within the expected normal values.	Hormonal Imbalance	4495	An imbalance of one or more hormones in the body	IMDRF:E1209
C54450	CDRH Health Effect - Clinical Code Terminology	C80099	Premature Menopause	Cessation of menstruation before the age of 40. Symptoms include hot flashes, night sweats, mood swings, and decreased sex drive.	Premature Menopause	4496	Menopause occurring spontaneously before 40 years of age	IMDRF:E1210
C54450	CDRH Health Effect - Clinical Code Terminology	C35772	Vitamin Deficiency Disorder	A disorder that is caused by the deficiency of a vitamin. The deficiency may result from either suboptimal vitamin intake or conditions that prevent the vitamin's use or absorption in the body. Representative examples include beriberi caused by thiamine deficiency, scurvy caused by vitamin C deficiency, and rickets caused by vitamin D deficiency.	Vitamin Deficiency	4497	Low levels of one or more vitamins in the body.	IMDRF:E1211
C54450	CDRH Health Effect - Clinical Code Terminology	C2999	Dysuria	Pain or discomfort during urination.	Dysuria	2684	Difficult or painful urination.	IMDRF:E1301
C54450	CDRH Health Effect - Clinical Code Terminology	C3090	Hematuria	Blood in the urine.	Hematuria	2558	Blood in the urine.	IMDRF:E1302
C54450	CDRH Health Effect - Clinical Code Terminology	C171995	Increased Intra-Peritoneal Volume	Overfill which occurs when there is more than the desired amount of fluid in the abdomen during peritoneal dialysis.	Increased Intra-Peritoneal Volume (IIPV)	4498	Abnormal build up of fluid in the abdomen.	IMDRF:E1303
C54450	CDRH Health Effect - Clinical Code Terminology	C50792	Urinary Urgency	An acute and compelling urge to urinate.	Micturition Urgency	1871	A sudden compelling urge to urinate.	IMDRF:E1304
C54450	CDRH Health Effect - Clinical Code Terminology	C114592	Renal Impairment	Diminished kidney function.	Renal Impairment	4499	An acute or chronic condition where the kidneys are not functioning normally.	IMDRF:E1305
C54450	CDRH Health Effect - Clinical Code Terminology	C4376	Renal Failure	An acute or chronic condition that is characterized by the inability of the kidneys to adequately filter the blood.	Renal Failure	2041	An acute or chronic condition that is characterized by the inability of the kidneys to adequately filter the blood resulting in uremia and electrolyte imbalances.	IMDRF:E130501
C54450	CDRH Health Effect - Clinical Code Terminology	C34851	Increased NPN	A laboratory test result indicating abnormally high concentration of non-protein nitrogen in the blood.	Uremia	2188	Abnormally high concentration of non-protein nitrogen in the blood.	IMDRF:E1306
C54450	CDRH Health Effect - Clinical Code Terminology	C79821	Urethral Stricture	Narrowing of the lumen of the urethra.	Urethral Stenosis/Stricture	4501	Narrowing of any part of the urethra. With or without affecting the flow of urine.	IMDRF:E1307
C54450	CDRH Health Effect - Clinical Code Terminology	C26906	Urinary Frequency	Urination at short intervals; it may result from increased urine formation, decreased bladder capacity, or lower urinary tract irritation.	Urinary Frequency	2275	Urination at short intervals; it may result from increased urine formation, decreased bladder capacity, or lower urinary tract irritation.	IMDRF:E1308
C54450	CDRH Health Effect - Clinical Code Terminology	C50790	Urinary Retention	Accumulation of urine within the bladder because of the inability to urinate.	Urinary Retention	2119	Accumulation of urine within the bladder because of the inability to urinate.	IMDRF:E1309
C54450	CDRH Health Effect - Clinical Code Terminology	C50791	Urinary Tract Infection	A bacterial infectious process affecting any part of the urinary tract, most commonly the bladder and the urethra. Symptoms include urinary urgency and frequency, burning sensation during urination, lower abdominal discomfort, and cloudy urine.	Urinary Tract Infection	2120	An inflammatory process affecting any part of the urinary tract, most commonly the bladder or the urethra.	IMDRF:E1310
C54450	CDRH Health Effect - Clinical Code Terminology	C34965	Pyelonephritis	An inflammatory process affecting the kidney. The cause is most often bacterial, but may also be fungal in nature. Signs and symptoms may include fever, chills, flank pain, painful and frequent urination, cloudy or bloody urine, and confusion.	Kidney Infection	4502	An inflammatory process affecting the kidney.	IMDRF:E131001
C54450	CDRH Health Effect - Clinical Code Terminology	C36286	Urinary System Finding	Symptoms, physical examination results, and/or laboratory test results related to the urinary system.	Unspecified Kidney or Urinary Problem	4503	The report describes a non-specific problem with the kidneys or urinary system. Note: Please use "Appropriate Term / Code Not Available" if the report describes a specific problem but the relevant term does not exist.	IMDRF:E1311
C54450	CDRH Health Effect - Clinical Code Terminology	C50795	Abnormal Vaginal Discharge	Abnormal secretions from the vagina.	Abnormal Vaginal Discharge	2123	Secretions from the vagina with a smell, colour, or texture which is different from normal.	IMDRF:E1401
C54450	CDRH Health Effect - Clinical Code Terminology	C78223	Breast Pain	Painful sensation in the breast region.	Breast Discomfort/Pain	4504	Having pain, tenderness or discomfort in the breast.	IMDRF:E1402
C54450	CDRH Health Effect - Clinical Code Terminology	C3197	Breast Lump	A mass in the mammary gland, either mobile or immobile. Once the mass has reached the size of a small garden pea, it can be detected by palpation. With mammography a larger number of early breast cancers are being detected since this techniques allows detection prior to the point at which the mass can be felt. Breast masses are not always malignant. Benign fibrocystic breast disease is not uncommon. A fine needle biopsy aspiration can distinguish a cystic mass from a solid one.	Breast Mass	2439	Abnormality in the breast parenchyma, identified either by palpation or imaging. These abnormalities include calcifications, breast tissue distortion, presence of areas of density, and presence of benign or malignant tumors.	IMDRF:E1403
C54450	CDRH Health Effect - Clinical Code Terminology	C50488	Cervical Change	An alteration in the cervix.	Cervical Changes	1773	Changes such as abnormal, pathological, benign, malignant, etc.	IMDRF:E1404
C54450	CDRH Health Effect - Clinical Code Terminology	C2997	Dyspareunia	Painful or difficult coitus.	Dyspareunia	4505	Painful or difficult coitus.	IMDRF:E1405
C54450	CDRH Health Effect - Clinical Code Terminology	C78294	Fallopian Tube Perforation	A rupture of the fallopian tube wall due to tubal pregnancy, or other traumatic or pathologic processes.	Fallopian Tube Perforation	4506	A rupture in the fallopian tube due to traumatic or pathologic processes.	IMDRF:E1406
C54450	CDRH Health Effect - Clinical Code Terminology	C79472	Reproductive System Hemorrhage	Bleeding originating in the organs and tissue that aid in reproduction.	Genital Bleeding	4507	Abnormal bleeding from the genitalia.	IMDRF:E1407
C54450	CDRH Health Effect - Clinical Code Terminology	C34818	Metrorrhagia	Uterine bleeding that occurs during a time not associated with the normal menstrual period.	Intermenstrual Bleeding	2665	Uterine bleeding that occurs during a time not associated with the normal menstrual period.	IMDRF:E140701
C54450	CDRH Health Effect - Clinical Code Terminology	C26829	Menorrhagia	Heavy bleeding during regular menstruation.	Menorrhagia	4508	Heavy or large blood loss during menses.	IMDRF:E140702
C54450	CDRH Health Effect - Clinical Code Terminology	C35219	Irregular Menstruation	Deviations from the normal process; e.g. delayed, difficult, profuse, scanty, unusual bleeding, etc.	Menstrual Irregularities	1959	Deviations from the normal process; e.g. delayed, difficult, profuse, scanty, unusual bleeding, etc.	IMDRF:E1408
C54450	CDRH Health Effect - Clinical Code Terminology	C50673	Nipple Sensation Change or Loss	Excessive sensitivity or changes in sensitivity in the nipple(s).	Nipple Sensation Changes	2162	Excessive sensitivity or changes in sensitivity in the nipple(s)	IMDRF:E1409
C54450	CDRH Health Effect - Clinical Code Terminology	C50674	Nipple Ulceration	Ulcer that develops in the nipple.  Causes include trauma and Paget disease.	Nipple Ulceration	2441	Ulcer that develops in the nipple.	IMDRF:E1410
C54450	CDRH Health Effect - Clinical Code Terminology	C3889	Pelvic Inflammatory Disease	Pelvic inflammatory disease (PID) is an acute or chronic inflammation in the pelvic cavity. It is most commonly caused by sexually transmitted diseases, including chlamydia and gonorrhea that have ascended into the uterus, fallopian tubes, or ovaries as a result of intercourse or childbirth, or of surgical procedures, including insertion of IUDs or abortion. PID may be either symptomatic or asymptomatic. It may cause infertility and it may raise the risk of ectopic pregnancy. PID is a disease associated with HIV infection.	Pelvic Inflammatory Disease	2000	Any pelvic infection involving the upper female genital tract beyond the cervix.	IMDRF:E1411
C54450	CDRH Health Effect - Clinical Code Terminology	C172026	Rectovaginal Fistula	Abnormal connection between rectum and vagina.	Rectovaginal Fistula	4509	Abnormal connection between rectum and vagina.	IMDRF:E1412
C54450	CDRH Health Effect - Clinical Code Terminology	C3347	Sexual Dysfunction	Disturbances in sexual desire or performance.	Sexual Dysfunction	4510	Difficulty, lack of desire, or pain associated with coitus.	IMDRF:E1413
C54450	CDRH Health Effect - Clinical Code Terminology	C3133	Impotence	Persistent or recurrent inability to achieve or to maintain an erection during sexual activity.	Erectile Dysfunction	4511	Persistent or recurrent inability to achieve or to maintain an erection during sexual activity.	IMDRF:E141301
C54450	CDRH Health Effect - Clinical Code Terminology	C35498	Toxic Shock Syndrome	A rare acute life-threatening systemic bacterial noncontagious illness caused by any of several related staphylococcal exotoxins. It is characterized by high fever, hypotension, rash, multi-organ dysfunction, and cutaneous desquamation during the early convalescent period. The toxins affect the host immune system, causing an exuberant and pathological host inflammatory response. Laboratory findings include leukocytosis, elevated prothrombin time, hypoalbuminemia, hypocalcemia, and pyuria.	Toxic Shock Syndrome	2108	A rare acute life-threatening systemic bacterial noncontagious illness caused by staphylococcal exotoxins.	IMDRF:E1414
C54450	CDRH Health Effect - Clinical Code Terminology	C50793	Uterine Perforation	A rupture in the uterus due to traumatic or pathologic processes.	Uterine Perforation	2121	A rupture in the uterus due to traumatic or pathologic processes.	IMDRF:E1415
C54450	CDRH Health Effect - Clinical Code Terminology	C172051	Vesicovaginal Fistula	Abnormal connection between vagina and bladder.	Vesicovaginal Fistula	4512	Abnormal connection between vagina and bladder.	IMDRF:E1416
C54450	CDRH Health Effect - Clinical Code Terminology	C172028	Reproductive System or Breast Problem	A non-specific problem with the breasts or reproductive system.	Unspecified Reproductive System or Breast Problem	4513	The report describes a non-specific problem with the breasts or reproductive system. Note: Please use "Appropriate Term / Code Not Available" if the report describes a specific problem but the relevant term does not exist.	IMDRF:E1417
C54450	CDRH Health Effect - Clinical Code Terminology	C187366	Breast Feeding Problem	Issues related to the ability to breastfeed.	Breast Feeding Problem	4829	Issues related to the ability to breastfeed.	IMDRF:E1418
C54450	CDRH Health Effect - Clinical Code Terminology	C35221	Abortion Finding	The unintentional or intentional loss of a pregnancy before 22 weeks gestation.	Abortion	1688	The unintentional or intentional loss of a pregnancy before 22 weeks gestation.	IMDRF:E1501
C54450	CDRH Health Effect - Clinical Code Terminology	C50500	Complete Abortion	Expulsion of all the products of conception following spontaneous, medical or operative pregnancy termination.	Complete Induced Abortion	2212	Expulsion of all the products of conception following medical or surgical pregnancy termination.	IMDRF:E150101
C54450	CDRH Health Effect - Clinical Code Terminology	C50608	Incomplete Abortion	The uterus is not entirely emptied of products of conception following spontaneous, medical or operative pregnancy termination.	Incomplete Induced Abortion	2213	The uterus is not entirely emptied of products of conception following medical or surgical pregnancy termination.	IMDRF:E150102
C54450	CDRH Health Effect - Clinical Code Terminology	C50613	Induced Abortion Finding	Abortion brought on intentionally.	Induced Abortion	2214	Abortion brought on intentionally.	IMDRF:E150103
C54450	CDRH Health Effect - Clinical Code Terminology	C50652	Missed Abortion	Retention in uterus of an abortus.	Missed Abortion	2215	Retention in uterus of an abortus.	IMDRF:E150104
C54450	CDRH Health Effect - Clinical Code Terminology	C34336	Spontaneous Abortion	Fetal loss at less than 20 weeks of gestation.	Spontaneous Abortion	4514	Spontaneous expulsion of a human fetus before it is viable.	IMDRF:E150105
C54450	CDRH Health Effect - Clinical Code Terminology	C50459	Amnionitis	Inflammation of the amnion.	Amnionitis	2217	Inflammation of the amnion.	IMDRF:E1502
C54450	CDRH Health Effect - Clinical Code Terminology	C50484	Cephalohematoma	A subperiosteal hemorrhage limited to the surface of one cranial bone, a usually benign condition seen in the newborn as a result of bone trauma.	Cephalohematoma	2599	A subperiosteal hemorrhage limited to the surface of one cranial bone, a usually benign condition seen in the newborn as a result of bone trauma.	IMDRF:E1503
C54450	CDRH Health Effect - Clinical Code Terminology	C26720	Chorioamnionitis	A morphologic finding indicating inflammation of the fetal sac membranes. It is characterized by neutrophilic infiltration of the amnion and chorion.	Chorioamnionitis	1777	An infection involving chorion, amnion and amniotic fluid; generally, there is also involve placental villi and from decidua.	IMDRF:E1504
C54450	CDRH Health Effect - Clinical Code Terminology	C2849	Congenital Abnormality	Any abnormality, anatomical or biochemical, evident at birth or during the neonatal period.	Congenital Defect/Deformity	1782	Any abnormality either hereditary or due an influence that happen during the pregnancy until the moment of birth.	IMDRF:E1505
C54450	CDRH Health Effect - Clinical Code Terminology	C34945	Ectopic Pregnancy	An abnormal pregnancy in which the conception is implanted outside the endometrial cavity.	Ectopic Pregnancy	1819	Pregnancy condition that happens when there is a developing fetus or embryo outside the uterus.	IMDRF:E1506
C54450	CDRH Health Effect - Clinical Code Terminology	C50563	Fetal Distress	Signs or symptoms which may be indicative of distress to a fetus, which may include repetitive variable decelerations, fetal tachycardia or bradycardia, late decelerations, or low biophysical profile.	Fetal Distress	1856	Signs or symptoms which may be indicative of distress to a fetus, which may include repetitive variable decelerations, fetal tachycardia or bradycardia, late decelerations, or low biophysical profile.	IMDRF:E1507
C54450	CDRH Health Effect - Clinical Code Terminology	C50564	Fetal Hypoxia	Hypoxia in utero, caused by conditions such as inadequate placental function (often abruptio placentae), preeclamptic toxicity, prolapse of the umbilical cord, or complications from anesthetic administration.	Hypoxia in Utero	2210	Caused by conditions such as inadequate placental function (often abruptio placentae), preeclamptic toxicity, prolapse of the umbilical cord, or complications from anesthetic administration.	IMDRF:E1508
C54450	CDRH Health Effect - Clinical Code Terminology	C50607	Incompetent Cervix	A clinical diagnosis presenting with painless cervical dilatation and spontaneous mid-trimester birth in recurrent pregnancies in the absence of spontaneous membrane rupture, bleeding or clinical chorioamnionitis.	Incompetent Cervix	1927	Cervix that is abnormally prone to dilate without contractions in the second trimester of pregnancy, resulting in premature expulsion of the fetus.	IMDRF:E1509
C54450	CDRH Health Effect - Clinical Code Terminology	C50416	Apgar Score Decreased or Low	An Apgar score less than seven.	Low Apgar Score	1718	Any Apgar score less than seven. This may be the initial or a subsequent apgar score.	IMDRF:E1510
C54450	CDRH Health Effect - Clinical Code Terminology	C50666	Neonatal Deformity	A congenital anatomic abnormality manifested during the neonatal period.	Neonatal Deformities	1974	Anatomic abnormality manifested during the neonatal period of physical or mechanical origin.	IMDRF:E1511
C54450	CDRH Health Effect - Clinical Code Terminology	C50667	Neonatal Hearing Impairment	An abnormality that affects hearing within the first month after birth. It may or may not result in hearing loss.	Neonatal Hearing Impairment	1975	An abnormality that affects hearing within the first month after birth.	IMDRF:E1512
C54450	CDRH Health Effect - Clinical Code Terminology	C171957	Complete Neonatal Hearing Loss	Complete loss of the ability to detect or understand sounds present in an infant within its first month after birth.	Complete Neonatal Hearing Loss	4515	Complete loss of the ability to detect or understand sounds present in an infant within its first month after birth.	IMDRF:E151201
C54450	CDRH Health Effect - Clinical Code Terminology	C172016	Partial Neonatal Hearing Loss	Partial loss of the ability to detect or understand sounds present in an infant within its first month after birth.	Partial Neonatal Hearing loss	4516	Partial loss of the ability to detect or understand sounds present in an infant within its first month after birth.	IMDRF:E151202
C54450	CDRH Health Effect - Clinical Code Terminology	C73501	Perinatal Brain Injury	Injury to the brain of a newborn infant occurring around the time of birth.	Perinatal Brain Injury	1852	Injury to the brain of a newborn infant occurring around the time of birth.	IMDRF:E1513
C54450	CDRH Health Effect - Clinical Code Terminology	C172022	Pregnancy with a Contraceptive Device	Pregnancy occurred despite using a contraceptive device.	Pregnancy with a Contraceptive Device	4517	The woman became pregnant despite using a contraceptive device.	IMDRF:E1514
C54450	CDRH Health Effect - Clinical Code Terminology	C50917	Premature Labor	Regular uterine activity with associated cervical change prior to 37 weeks gestation.	Premature Labor	2465	Delivery of a viable infant before the normal end of gestation.	IMDRF:E1515
C54450	CDRH Health Effect - Clinical Code Terminology	C27560	Respiratory Distress Syndrome	A condition beginning in the first day of life that results from inadequate surfactant production, causing increased work of breathing and impaired gas exchange.	Respiratory Distress Syndrome of Newborns	2046	A condition of the newborn marked by dyspnea with cyanosis.	IMDRF:E1516
C54450	CDRH Health Effect - Clinical Code Terminology	C50916	Teratogenic Effect	The result of processes that negatively affect a developing fetus.	Teratogenic Effects	2273	Appearance of anomalies and/or developmental defects due to exposure to an agent that can disturb the development of an embryo or fetus.	IMDRF:E1517
C54450	CDRH Health Effect - Clinical Code Terminology	C50493	Child Intoxication With Breast Implant Material Ingredients	Children affected by toxins may be due to silicone breast implants and their effects on unborn children and from breastfeeding.	Toxins In Children	2098	Children affected by toxins may be due to silicone breast implants and their effects on unborn children and from breastfeeding.	IMDRF:E1518
C54450	CDRH Health Effect - Clinical Code Terminology	C50522	Damage of Vaginal Mucosa	Injury to vaginal mucosa.	Vaginal Mucosa Damage	2124	Injury to vaginal mucosa.	IMDRF:E1519
C54450	CDRH Health Effect - Clinical Code Terminology	C3836	Infertility	Inability to conceive for at least one year after trying and having unprotected sex. Causes of female infertility include endometriosis, fallopian tubes obstruction, and polycystic ovary syndrome. Causes of male infertility include abnormal sperm production or function, blockage of the epididymis, blockage of the ejaculatory ducts, hypospadias, exposure to pesticides, and health related issues.	Infertility	4830	Inability to conceive for at least one year after trying and having unprotected sex. Causes of female infertility include endometriosis, fallopian tubes obstruction, and polycystic ovary syndrome. Causes of male infertility include abnormal sperm production or function, blockage of the epididymis, blockage of the ejaculatory ducts and hypospadias.	IMDRF:E1520
C54450	CDRH Health Effect - Clinical Code Terminology	C50464	Arthralgia	Pain in a joint.	Arthralgia	2355	Pain in a joint.	IMDRF:E1601
C54450	CDRH Health Effect - Clinical Code Terminology	C2883	Arthritis	An inflammatory process affecting a joint. Causes include infection, autoimmune processes, degenerative processes, and trauma. Signs and symptoms may include swelling around the affected joint and pain.	Arthritis	1723	An inflammatory process affecting a joint.	IMDRF:E1602
C54450	CDRH Health Effect - Clinical Code Terminology	C2884	Rheumatoid Arthritis	A chronic, systemic autoimmune disorder characterized by inflammation in the synovial membranes and articular surfaces. It manifests primarily as a symmetric, erosive polyarthritis that spares the axial skeleton and is typically associated with the presence in the serum of rheumatoid factor.	Rheumatoid Arthritis	1724	A chronic systemic disease, primarily of the joints, marked by inflammatory changes in the synovial membranes and articular structures, widespread fibrinoid degeneration of the collagen fibers in mesenchymal tissues, and by atrophy and rarefaction of bony structures.	IMDRF:E160201
C54450	CDRH Health Effect - Clinical Code Terminology	C3046	Fracture	A traumatic injury to the bone in which the continuity of the bone is broken.	Bone Fracture(s)	1870	A traumatic or pathological injury to the bone in which the continuity of the bone is broken.	IMDRF:E1603
C54450	CDRH Health Effect - Clinical Code Terminology	C26794	Hip Fracture	Traumatic or pathological injury to the hip in which the continuity of either the femoral head, femoral neck, intertrochanteric or subtrochanteric regions is broken. Symptoms include pain in the hip or groin, bruising and swelling in and around the hip area. The injured hip is turned outward and the leg appears shorter on that side.	Hip Fracture	2349	Traumatic or pathological injury to the hip in which the continuity of either the femoral head, femoral neck, intertrochanteric or subtrochanteric regions is broken.	IMDRF:E160301
C54450	CDRH Health Effect - Clinical Code Terminology	C172003	Limb Fracture	A traumatic break in one or more bones in a limb.	Limb Fracture	4518	A traumatic break in one or more of the bones in a limb.	IMDRF:E160302
C54450	CDRH Health Effect - Clinical Code Terminology	C26778	Multiple Fractures	Two or more simultaneous traumatic breaks in one or more bones.	Multiple Fractures	4519	Two or more simultaneous traumatic breaks in one or more bones.	IMDRF:E160303
C54450	CDRH Health Effect - Clinical Code Terminology	C50745	Skull Fracture	A traumatic or pathologic injury to the bones of the skull in which the continuity of the bones of the skull is broken.	Skull Fracture	2077	A traumatic or pathologic injury to the bones of the skull in which the continuity of the bones of the skull is broken.	IMDRF:E160304
C54450	CDRH Health Effect - Clinical Code Terminology	C80516	Vertebral Fracture	Traumatic or pathological injury to the spine in which the continuity of a vertebral bone is broken. Symptoms include back pain and difficulty bending and twisting.	Vertebral Fracture	4520	Traumatic or pathological injury to the spine in which the continuity of a vertebral bone is broken.	IMDRF:E160305
C54450	CDRH Health Effect - Clinical Code Terminology	C26729	Connective Tissue Disorder	A non-neoplastic or neoplastic disorder that affects the connective tissue.	Connective Tissue Disease	1786	A non-neoplastic or neoplastic disorder that affects the connective tissue.	IMDRF:E1604
C54450	CDRH Health Effect - Clinical Code Terminology	C34827	Muscle Cramp	A sustained, sudden and involuntary contraction of a muscle or group of muscles.	Cramp(s) /Muscle Spasm(s)	4521	A sustained, sudden and involuntary contraction of a muscle or group of muscles.	IMDRF:E1605
C54450	CDRH Health Effect - Clinical Code Terminology	C34331	Abdominal Cramp	An involuntary muscular contraction involving a muscle of the abdomen or of a hollow organ within the abdomen.	Abdominal Cramps	2543	An involuntary muscular contraction involving a muscle of the abdomen or of a hollow organ within the abdomen.	IMDRF:E160501
C54450	CDRH Health Effect - Clinical Code Terminology	C50633	Ligament Injury	An injury to any of the fibrous bands of tissue that comprise an articulation (joint).	Damage to Ligament(s)	1952	An injury to any of the fibrous bands of tissue that comprise an articulation (joint).	IMDRF:E1606
C54450	CDRH Health Effect - Clinical Code Terminology	C50492	Chewing Difficulty	Pain or discomfort with mastication, a symptom of underlying disease. Causes can include problems with the teeth, jaws or temporomandibular joint, mumps, cancer, or a neuromuscular disorder.	Difficulty Chewing	4522	Problem with mastication due to pain, discomfort or loss of mobility in the jaw.	IMDRF:E1607
C54450	CDRH Health Effect - Clinical Code Terminology	C50559	Fasciitis	Inflammation process in fascia.	Fasciitis	2375	Inflammation of fascia.	IMDRF:E1608
C54450	CDRH Health Effect - Clinical Code Terminology	C50566	Fibromyositis	Inflammation and fibrous degeneration of a muscle.	Fibromyositis	1860	Inflammation and fibrous degeneration of a muscle.	IMDRF:E1609
C54450	CDRH Health Effect - Clinical Code Terminology	C34660	Head Injury	A traumatic injury to the head.	Head Injury	1879	A traumatic injury to the head.	IMDRF:E1610
C54450	CDRH Health Effect - Clinical Code Terminology	C98951	Hyperextension	A finding indicating that joints, muscles, and/or tendons can extend beyond their normal limit.	Hyperextension	4523	Forceful extension of a joint beyond its normal limits.	IMDRF:E1611
C54450	CDRH Health Effect - Clinical Code Terminology	C50914	Inadequate Osteointegration	Insufficient structural and functional connection between living bone and the surface of a synthetic implant.	Inadequate Osseointegration	2646	Insufficient structural and functional connection between living bone and the surface of a synthetic implant.	IMDRF:E1612
C54450	CDRH Health Effect - Clinical Code Terminology	C171999	Intervertebral Disc Compression or Protrusion	Degenerative, pathological or traumatic changes in the cartilaginous tissue of the spine leading to unwanted compression or protrusion of the disc.	Intervertebral Disc Compression or Protrusion	4524	Degenerative, pathological or traumatic changes in the cartilaginous tissue of the spine leading to unwanted compression or protrusion of the disc.	IMDRF:E1613
C54450	CDRH Health Effect - Clinical Code Terminology	C26750	Joint Dislocation	An abnormal separation where two or more bones meet.	Joint Dislocation	2374	An abnormal separation where two or more bones meet.	IMDRF:E1614
C54450	CDRH Health Effect - Clinical Code Terminology	C172034	Subluxation	Partial dislocation of the bones in a joint.	Subluxation	4525	Partial dislocation of the bones in a joint.	IMDRF:E161401
C54450	CDRH Health Effect - Clinical Code Terminology	C172000	Joint Laxity	Looseness or instability of a joint.	Joint Laxity	4526	Looseness or instability of a joint.	IMDRF:E1615
C54450	CDRH Health Effect - Clinical Code Terminology	C50637	Loss of Range of Motion	A finding that the flexibility of a joint is below the expected range of normal for that individual.	Loss of Range of Motion	2032	A finding that the flexibility of a joint is below the expected range of normal for that individual.	IMDRF:E1616
C54450	CDRH Health Effect - Clinical Code Terminology	C171941	Ankylosis	Immobility of the joint due to the formation of bone, cartilaginous or fibrous tissues around the joint.	Ankylosis	4527	Immobility of the joint due to the formation of bone, cartilaginous or fibrous tissues around the joints.	IMDRF:E161601
C54450	CDRH Health Effect - Clinical Code Terminology	C124948	Joint Contracture	Permanent shortening of a joint, usually resulting from prolonged spasticity in a muscle area.	Joint Contracture	4528	Permanent restriction of a joint, usually resulting from prolonged spasticity in a muscle area.	IMDRF:E161602
C54450	CDRH Health Effect - Clinical Code Terminology	C50659	Muscular Rigidity	An involuntary, persistent state of firm, tense muscles with marked resistance to passive movement.	Muscular Rigidity	1968	An involuntary, persistent state of firm, tense muscles with marked resistance to passive movement.	IMDRF:E161603
C54450	CDRH Health Effect - Clinical Code Terminology	C118393	Malunion of Bone	Faulty healing of bone, resulting in improper anatomical alignment.	Malunion of Bone	4529	Faulty healing of bone, resulting in improper anatomical alignment.	IMDRF:E1617
C54450	CDRH Health Effect - Clinical Code Terminology	C172007	Metallosis	Aseptic fibrosis or local necrosis secondary to metal corrosion and release of wear debris.	Metal Related Pathology	4530	Also known as Metallosis. Includes trunnionosis, aseptic fibrosis or local necrosis secondary to metal corrosion and release of wear debris.	IMDRF:E1618
C54450	CDRH Health Effect - Clinical Code Terminology	C87070	Hypotonia	A condition of decreased tone of the skeletal muscles and diminished resistance to passive stretching.	Muscle Hypotonia	4531	Abnormally low level of muscle tone.	IMDRF:E1619
C54450	CDRH Health Effect - Clinical Code Terminology	C110943	Musculoskeletal Injury	Damage to the muscles, bones and their supportive structural attachments.	Muscle/Tendon Damage	4532	Any injury to muscle or tendon tissue including strains.	IMDRF:E1620
C54450	CDRH Health Effect - Clinical Code Terminology	C187271	Muscle Weakness/Atrophy	A reduction in the strength and/or mass of one or more muscles.	Muscle Weakness/Atrophy	1967	A reduction in the strength and/or mass of one or more muscles.	IMDRF:E1621
C54450	CDRH Health Effect - Clinical Code Terminology	C27009	Myalgia	Painful sensation originating from a muscle or group of muscles.	Myalgia	2238	Pain sensation originating from a muscle or group of muscles.	IMDRF:E1622
C54450	CDRH Health Effect - Clinical Code Terminology	C50663	Neck Pain	Painful sensation in the neck area.	Neck Pain	2433	Pain in the neck area.	IMDRF:E1623
C54450	CDRH Health Effect - Clinical Code Terminology	C50664	Neck Stiffness	Limited mobility of the neck, usually accompanied by pain.	Neck Stiffness	2434	Limited mobility of the neck, usually accompanied by pain.	IMDRF:E1624
C54450	CDRH Health Effect - Clinical Code Terminology	C50529	Delayed Union Fracture	A bone fracture that is taking an abnormally long time to heal.	Nonunion/Delayed-union Bone Fracture	2369	Broken bone that doesn't heal or is delayed in healing.	IMDRF:E1625
C54450	CDRH Health Effect - Clinical Code Terminology	C50680	Ossification	The formation of bone or of a bony substance; the conversion of fibrous tissue or of cartilage into bone or a bony substance.	Ossification	1428	The formation of bone or of a bony substance; the conversion of fibrous tissue or of cartilage into bone or a bony substance.	IMDRF:E1626
C54450	CDRH Health Effect - Clinical Code Terminology	C50681	Osteolysis	Dissolution of bone; applied especially to the removal or loss of the calcium of bone.	Osteolysis	2377	Dissolution of bone; applied especially to the removal or loss of the calcium of bone.	IMDRF:E1627
C54450	CDRH Health Effect - Clinical Code Terminology	C27577	Osteomyelitis	An acute or chronic inflammation of the bone and its structures due to infection with pyogenic bacteria.	Osteomyelitis	4533	Infection of bone or bone marrow.	IMDRF:E1628
C54450	CDRH Health Effect - Clinical Code Terminology	C50910	Osteopenia	Decreased calcification or density of bone tissue.	Osteopenia/ Osteoporosis	2651	Decreased calcification or density of bone tissue.	IMDRF:E1629
C54450	CDRH Health Effect - Clinical Code Terminology	C26925	Polymyositis	An idiopathic inflammatory disorder affecting the muscles. It presents with symmetrical proximal muscle weakness and elevated skeletal muscle enzymes.	Polymyositis	1992	An idiopathic inflammatory disorder affecting the muscles. It presents with symmetrical proximal muscle weakness and elevated skeletal muscle enzymes.	IMDRF:E1630
C54450	CDRH Health Effect - Clinical Code Terminology	C50751	Spinal Injury	Damage to the spine that results in impaired function.	Spinal Column Injury	2081	Damage to the bones of the spine.	IMDRF:E1631
C54450	CDRH Health Effect - Clinical Code Terminology	C50766	Synovitis	Inflammation of a synovial membrane.	Synovitis	2094	Inflammation of a synovial membrane.	IMDRF:E1632
C54450	CDRH Health Effect - Clinical Code Terminology	C50777	Tooth Fracture	Broken tooth affecting any portion of tooth: root fracture, crown-root, broken tooth (crown fracture), chipped tooth. A crown fracture can involve the pulp. Tooth fracture sequelae range in severity from cosmetic defects to tooth death. Involvement of the pulp is a more important indicator of severity of tooth fracture than is the amount of the tooth affected.	Tooth Fracture	2428	Breakage of any portion of the tooth.	IMDRF:E1633
C54450	CDRH Health Effect - Clinical Code Terminology	C78657	Unequal Limb Length	Discrepancy between the lengths of the lower or upper extremities.	Unequal Limb Length	4534	Discrepancy between the lengths of the lower or upper extremities.	IMDRF:E1634
C54450	CDRH Health Effect - Clinical Code Terminology	C110937	Musculoskeletal Finding	Symptoms, physical examination results, and/or laboratory rest results related to the muscles and bones.	Unspecified Musculoskeletal problem	4535	The report describes a non-specific problem with the musculoskeletal system. Note: Please use "Appropriate Term / Code Not Available" if the report describes a specific problem but the relevant term does not exist.	IMDRF:E1635
C54450	CDRH Health Effect - Clinical Code Terminology	C187368	Tooth Loss	One or more teeth lost/dislodged from the mouth.	Tooth Loss	4831	One or more teeth lost/dislodged from the mouth.	IMDRF:E1636
C54450	CDRH Health Effect - Clinical Code Terminology	C94407	Bursitis	Painful inflammation of the bursa. It most often affects the hips, shoulders, and elbows.	Bursitis	4832	Inflammation of the fluid-filled pad (bursa).	IMDRF:E1637
C54450	CDRH Health Effect - Clinical Code Terminology	C35606	Cartilage Injury	Trauma to cartilage.	Cartilage damage	4833	Damage of cartilage.	IMDRF:E1638
C54450	CDRH Health Effect - Clinical Code Terminology	C187369	Joint Impingement	A painful condition caused by the friction of joint tissues.	Joint Impingement	4834	Impingement relating to joints. Can be e.g. implant-on-bone, implant-on-soft tissue, or implant-on-implant impingement.	IMDRF:E1639
C54450	CDRH Health Effect - Clinical Code Terminology	C128368	Mastoiditis	Inflammation of the mucosal lining of the mastoid antrum and mastoid air cell system of the mastoid process.	Mastoiditis	4835	An infection of the bony air cells in the mastoid bone.	IMDRF:E1640
C54450	CDRH Health Effect - Clinical Code Terminology	C187370	Limb Pain	Pain in the arm(s) and/or leg(s).	Limb Pain	4836	Pain in the arms and/or legs.	IMDRF:E1641
C54450	CDRH Health Effect - Clinical Code Terminology	C50449	Abrasion	Superficial damage to the skin caused by rubbing or scraping.	Abrasion	1689	Superficial damage to the skin caused by rubbing or scraping.	IMDRF:E1701
C54450	CDRH Health Effect - Clinical Code Terminology	C112175	Angioedema	Rapid swelling of the deep layers of the skin due to transient vascular leakage of serous fluid.	Angioedema	4536	Rapid swelling of the deep layers of the skin due to transient vascular leakage of serous fluid.	IMDRF:E1702
C54450	CDRH Health Effect - Clinical Code Terminology	C75564	Blister	An intraepidermal/subepidermal cavity filled with clear, serosanguineous or cloudy fluid.	Blister	4537	A collection of fluid underneath the top layer of skin.	IMDRF:E1703
C54450	CDRH Health Effect - Clinical Code Terminology	C34441	Burn	A traumatic injury involving interruption of tissue cohesiveness that results from exposure to caustic chemicals, extreme heat, extreme cold or excessive radiation.	Burn(s)	1757	An injury or tissue damage caused by exposure to caustic chemicals, extreme heat, extreme cold or excessive radiation.	IMDRF:E1704
C54450	CDRH Health Effect - Clinical Code Terminology	C34442	Chemical Burn	A burn caused by exposure to chemical substances.	Caustic/Chemical Burns	2549	A burn caused by exposure to chemical substances.	IMDRF:E170401
C54450	CDRH Health Effect - Clinical Code Terminology	C171960	Cryogenic Burn	Local tissue damage due to exposure to extreme cold.	Cryogenic Burn	4539	Local tissue damage due to exposure to extreme cold.	IMDRF:E170402
C54450	CDRH Health Effect - Clinical Code Terminology	C50722	Radiation Burn	A burn caused by exposure to x-ray, radium, sunlight, atomic or any other type of radiant energy.	Radiation Burn	1755	A burn caused by exposure to x-ray, radium, sunlight, ionizing radiation or any other type of radiant energy.	IMDRF:E170403
C54450	CDRH Health Effect - Clinical Code Terminology	C76130	First-Degree Burn	A painful injury to the epidermis due to chemical, friction, radiation or thermal exposure. The affected area appears red and blanches when touched.	Superficial (First Degree) Burn	2685	A burn that affects the epidermis only, causing erythema without blistering.	IMDRF:E170404
C54450	CDRH Health Effect - Clinical Code Terminology	C76131	Second-Degree Burn	An injury that includes the entire epidermis and upper layers of the dermis due to a chemical, friction, radiation or thermal exposure. The affected area appears as moist red or white skin that does not blanch. Often it is painful with the presence of blisters.	Partial thickness (Second Degree) Burn	2694	A burn that affects the epidermis and the dermis.	IMDRF:E170405
C54450	CDRH Health Effect - Clinical Code Terminology	C76132	Third-Degree Burn	An injury that includes all skin layers into the subcutaneous tissue due to chemical, friction, radiation or thermal exposure. The affected area appears dry and thickened; damage to nerve endings usually renders the wound painless.	Full thickness (Third Degree) Burn	2696	A burn to the skin that extends into deeper layers and underlying tissues.	IMDRF:E170406
C54450	CDRH Health Effect - Clinical Code Terminology	C50476	Burning Sensation	A sensation of stinging or heat, not necessarily accompanied by redness or physical signs of irritation.	Burning Sensation	2146	A sensation of stinging or heat, not necessarily accompanied by redness or physical signs of irritation.	IMDRF:E1705
C54450	CDRH Health Effect - Clinical Code Terminology	C35297	Skin Burning Sensation	A sensation of dermal stinging or heat, not necessarily accompanied by redness or physical signs of skin irritation.	Skin Burning Sensation	4540	A sensation of dermal stinging or heat, not necessarily accompanied by redness or physical signs of skin irritation.	IMDRF:E170501
C54450	CDRH Health Effect - Clinical Code Terminology	C172041	Tumor Cell Seeding	The spread of benign or malignant tissue during medical or surgical procedures.	Cancer Cells Dissemination	4541	Spreading benign or malignant tissue during medical procedures.	IMDRF:E1706
C54450	CDRH Health Effect - Clinical Code Terminology	C50601	Impaired Healing	Improper body tissue repair due to factors affecting one or more of the phases of wound healing, including hemostasis, inflammation, proliferation, and remodeling.	Impaired Healing	2378	Improper body tissue repair due to factors affecting one or more of the phases of wound healing.	IMDRF:E1707
C54450	CDRH Health Effect - Clinical Code Terminology	C3344	Pruritus	An intense itching sensation.	Itching Sensation	1943	An irritating feeling that produces the desire to scratch.	IMDRF:E1708
C54450	CDRH Health Effect - Clinical Code Terminology	C3143	Jaundice	Yellow pigmentation of the skin, mucous membranes, and the eyes due to hyperbilirubinemia. Causes include liver disease, biliary tract obstruction, and hemolysis.	Jaundice	2187	Yellow pigmentation of the skin, mucous membranes, and the eyes due to hyperbilirubinemia.	IMDRF:E1709
C54450	CDRH Health Effect - Clinical Code Terminology	C39688	Localized Skin Lesion	A pathologic process that affects the skin and is confined to a specific area.	Localized Skin Lesion	4542	A pathologic process that affects the skin and is confined to a specific area.	IMDRF:E1710
C54450	CDRH Health Effect - Clinical Code Terminology	C50691	Peeling	A peeling off or loss of epidermis, as in sunburn, postscarlatinal peeling, or toxic epidermal necrolysis.	Peeling	1999	A peeling off or loss of epidermis, as in sunburn, postscarlatinal peeling, or toxic epidermal necrolysis.	IMDRF:E1711
C54450	CDRH Health Effect - Clinical Code Terminology	C50698	Phototoxicity	A nonimmunologic, chemically induced type of photosensitivity.	Phototoxicity	2165	A nonimmunologic, chemically induced type of photosensitivity.	IMDRF:E1712
C54450	CDRH Health Effect - Clinical Code Terminology	C50699	Pocket Erosion	Erosion of patient's skin pocket which houses a device.	Pocket Erosion	2013	Erosion of patient's tissue pocket which houses a device.	IMDRF:E1713
C54450	CDRH Health Effect - Clinical Code Terminology	C39594	Skin Rash	Any change in the skin which affects its appearance or texture. A rash may be localized to one part of the body, or affect all the skin. Rashes may cause the skin to change color, itch, become warm, bumpy, dry, cracked or blistered, swell and may be painful.	Rash	2033	An eruption in the skin which effects its appearance and/or texture.	IMDRF:E1714
C54450	CDRH Health Effect - Clinical Code Terminology	C50737	Skin Scar	Formation of new tissue formed in the healing of a wound.	Scar Tissue	2060	Formation of new tissue formed in the healing of a wound.	IMDRF:E1715
C54450	CDRH Health Effect - Clinical Code Terminology	C3327	Skin Discoloration	Abnormal skin coloration.	Skin Discoloration	2074	any abnormal change in skin coloration.	IMDRF:E1716
C54450	CDRH Health Effect - Clinical Code Terminology	C26901	Erythema	Red discoloration of the skin caused by infectious agents, inflammation, drug hypersensitivity, or underlying disease.	Erythema	1840	Red discoloration of the skin.	IMDRF:E171601
C54450	CDRH Health Effect - Clinical Code Terminology	C79731	Skin Hyperpigmentation	Darkening of the skin due to excessive melanin deposition. Causes include skin injuries, pregnancy, eczema, and Addison disease.	Hyperpigmentation	4837	Darkening of the skin due to excessive melanin deposition.	IMDRF:E171602
C54450	CDRH Health Effect - Clinical Code Terminology	C78610	Skin Hypopigmentation	Abnormal lightening of skin due to decreased melanin production or deposition. Vitiligo, albinism, and leukoderma are among the disorders that are associated with skin hypopigmentation.	Hypopigmentation	4838	Abnormal lightening of skin due to decreased melanin production or deposition.	IMDRF:E171603
C54450	CDRH Health Effect - Clinical Code Terminology	C3371	Skin Disorder	Any deviation from the normal structure or function of the skin or subcutaneous tissue that is manifested by a characteristic set of symptoms and signs.	Skin Disorders	4543	Affecting the skin.	IMDRF:E1717
C54450	CDRH Health Effect - Clinical Code Terminology	C50845	Skin Erosion	Tearing or wearing off of skin.	Skin Erosion	2075	A gradual breakdown or very shallow ulceration of the skin which involves only the epidermis and heals without scarring.	IMDRF:E1718
C54450	CDRH Health Effect - Clinical Code Terminology	C35025	Skin Infection	An inflammatory process affecting the skin, caused by bacteria, viruses, parasites, or fungi. Examples of bacterial infection include carbuncles, furuncles, impetigo, erysipelas, and abscesses. Examples of viral infection include shingles, warts, molluscum contagiosum, and pityriasis rosea. Examples of parasitic infection include scabies and lice. Examples of fungal infection include athlete's foot, yeast infection, and ringworm.	Skin Infection	4544	An inflammatory process affecting the skin, caused by bacteria, viruses, parasites, or fungi.	IMDRF:E1719
C54450	CDRH Health Effect - Clinical Code Terminology	C2983	Dermatitis	An inflammatory process affecting the skin. Signs include red rash, itching, and blister formation. Representative examples are contact dermatitis, atopic dermatitis, and seborrheic dermatitis.	Skin Inflammation/ Irritation	4545	An inflammatory process affecting the skin. Signs include red rash, itching, and blister formation. Representative examples are contact dermatitis, atopic dermatitis, and seborrheic dermatitis.	IMDRF:E1720
C54450	CDRH Health Effect - Clinical Code Terminology	C26686	Abscess	An inflammatory process characterized by the accumulation of pus within a newly formed tissue cavity which is the result of a bacterial, fungal, or parasitic infection or the presence of a foreign body.	Abscess	1690	An inflammatory process characterized by the accumulation of pus within a newly formed tissue cavity.	IMDRF:E172001
C54450	CDRH Health Effect - Clinical Code Terminology	C26715	Cellulitis	Inflammation of the dermis and subcutaneous tissues caused by a bacterial infection. Symptoms include erythema, edema, and pain to the affected area.	Cellulitis	1768	Inflammation of the dermis and subcutaneous tissues caused by a bacterial infection.	IMDRF:E172002
C54450	CDRH Health Effect - Clinical Code Terminology	C26743	Contact Dermatitis	An inflammatory skin condition caused by direct contact between the skin and either an irritating substance or an allergen.	Contact Dermatitis	4546	An inflammatory skin condition caused by direct contact between the skin and either an irritating substance or an allergen.	IMDRF:E172003
C54450	CDRH Health Effect - Clinical Code Terminology	C3001	Eczema	A form of dermatitis characterized by red, itchy, scaly, or crusty patches that can be chronic or intermittent.	Eczema	4547	A form of dermatitis characterized by red, itchy, scaly, or crusty patches that can be chronic or intermittent.	IMDRF:E172004
C54450	CDRH Health Effect - Clinical Code Terminology	C3349	Radiation-Induced Dermatitis	A cutaneous inflammatory reaction occurring as a result of exposure to biologically effective levels of ionizing radiation.	Radiodermatitis	2255	A cutaneous inflammatory reaction occurring as a result of exposure to biologically effective levels of ionizing radiation.	IMDRF:E172005
C54450	CDRH Health Effect - Clinical Code Terminology	C3432	Urticaria	A transient, itchy skin eruption characterized by wheals with pale interiors and red margins.	Urticaria	2278	A transient, itchy skin eruption characterized by wheals with pale interiors and red margins.	IMDRF:E172006
C54450	CDRH Health Effect - Clinical Code Terminology	C50811	Wheal	A smooth, slightly elevated area on the body surface, which is redder or paler than the surrounding skin. It is the typical lesion of urticaria, the dermal evidence of allergy, and in sensitive persons may be provoked by mechanical irritation of the skin.	Wheal(s)	2241	A smooth, slightly elevated area on the body surface, which is redder or paler than the surrounding skin.	IMDRF:E172007
C54450	CDRH Health Effect - Clinical Code Terminology	C50744	Skin Tear	A break in skin tissue caused by friction or shearing.	Skin Tears	2516	A break in skin tissue caused by friction or shearing.	IMDRF:E1721
C54450	CDRH Health Effect - Clinical Code Terminology	C39618	Subcutaneous Nodule	A small palpable mass in the subcutaneous tissues.	Subcutaneous Nodule	4548	A small palpable abnormal mass in the subcutaneous tissues.	IMDRF:E1722
C54450	CDRH Health Effect - Clinical Code Terminology	C50435	Skin Wrinkling	A fold, ridge or crease of the skin.	Wrinkling	2613	A folding, ridge or creasing of the skin.	IMDRF:E1723
C54450	CDRH Health Effect - Clinical Code Terminology	C74592	Dry Skin	The pores are generally fine with a papery thin texture that feels dry to the touch. Usually flaky and dull looking.	Dry Skin	4839	Skin that has become dry in texture and flaky.	IMDRF:E1724
C54450	CDRH Health Effect - Clinical Code Terminology	C187371	Injection Site Pooling	Liquid or a pocket of air trapped under the skin, typically due to injection procedures.	Injection Site Pooling	4840	Liquid or a pocket of air trapped under the skin, typically due to injection problems. Does not include inflammation.	IMDRF:E1725
C54450	CDRH Health Effect - Clinical Code Terminology	C83472	Skin Maceration	Softening and whitening of the skin due to excessive moisture.	Skin Maceration	4841	Softening of tissue by the action of a liquid. Occurs at the wound site/surrounding areas due to excessive moisture from exudate or products applied.	IMDRF:E1726
C54450	CDRH Health Effect - Clinical Code Terminology	C9305	Malignant Neoplasm	A tumor composed of atypical neoplastic, often pleomorphic cells that invade other tissues. Malignant neoplasms often metastasize to distant anatomic sites and may recur after excision. The most common malignant neoplasms are carcinomas, Hodgkin and non-Hodgkin lymphomas, leukemias, melanomas, and sarcomas.	Cancer	3262	A group of diseases in which abnormal cells divide without control, invade nearby tissues and may also spread to other parts of the body through the blood and lymph systems.	IMDRF:E1801
C54450	CDRH Health Effect - Clinical Code Terminology	C4872	Breast Carcinoma	A carcinoma arising from the breast, most commonly the terminal ductal-lobular unit. It is the most common malignant tumor in females. Risk factors include country of birth, family history, menstrual and reproductive history, fibrocystic disease and epithelial hyperplasia, exogenous estrogens, contraceptive agents, and ionizing radiation. The vast majority of breast carcinomas are adenocarcinomas (ductal or lobular). Breast carcinoma spreads by direct invasion, by the lymphatic route, and by the blood vessel route. The most common site of lymph node involvement is the axilla.	Breast Cancer	1759	A malignant neoplasm that develops or arises in breast tissue.	IMDRF:E180101
C54450	CDRH Health Effect - Clinical Code Terminology	C139012	Breast Implant-Associated Anaplastic Large Cell Lymphoma	A rare anaplastic large cell lymphoma that can develop following breast implants. It has been reported in patients with saline-and silicone-filled implants. It usually presents as an accumulation of seroma fluid between the implant and the surrounding fibrous capsule. The median interval from the time of the implant to the development of lymphoma is approximately 10 years.	Breast Implant Associated Anaplastic Large Cell Lymphoma (BIA ALCL)	4549	A non-Hodgkin lymphoma which is associated with breast implants, and consists of large anaplastic cells. The WHO diagnostic criteria for BIA-ALCL includes positive expression of CD30 (CD30+) and negativity for anaplastic lymphoma kinase (ALK-).	IMDRF:E180102
C54450	CDRH Health Effect - Clinical Code Terminology	C3158	Leiomyosarcoma	An uncommon, aggressive malignant smooth muscle neoplasm, usually occurring in post-menopausal women.  It is characterized by a proliferation of neoplastic spindle cells.  Morphologic variants include epithelioid, granular cell, inflammatory and myxoid leimyosarcomas.	Leiomyosarcoma	4550	A malignant tumor of smooth muscle cells that can arise almost anywhere in the body but is most common in the uterus, abdomen, or pelvis.	IMDRF:E180103
C54450	CDRH Health Effect - Clinical Code Terminology	C3208	Lymphoma	A malignant (clonal) proliferation of B- lymphocytes or T- lymphocytes which involves the lymph nodes, bone marrow and/or extranodal sites. This category includes Non-Hodgkin lymphomas and Hodgkin lymphomas.	Lymphoma	3263	A malignant (clonal) proliferation of B- lymphocytes or T- lymphocytes which involves the lymph nodes, bone marrow and/or extranodal sites. This category includes Non-Hodgkin lymphomas and Hodgkin lymphomas.	IMDRF:E180104
C54450	CDRH Health Effect - Clinical Code Terminology	C50520	Cyst Formation	A morphologic finding indicating the presence of cystic structures in a tissue sample.	Cyst(s)	1800	A sac-like closed membranous structure that may be empty or contain fluid or amorphous material.	IMDRF:E1802
C54450	CDRH Health Effect - Clinical Code Terminology	C3280	Nodule	A small lump, swelling or collection of tissue.	Nodule	4551	A small lump, swelling or collection of tissue.	IMDRF:E1803
C54450	CDRH Health Effect - Clinical Code Terminology	C9292	Solid Neoplasm	A benign or malignant neoplasm arising from tissues that do not include fluid areas.  Representative examples include epithelial neoplasms (e.g. lung carcinoma, prostate carcinoma, breast carcinoma, colon carcinoma), and neoplasms arising from the soft tissues and bones (e.g. leiomyosarcoma, liposarcoma, chondrosarcoma, osteosarcoma).  Neoplasms originating from the blood or bone marrow (leukemias and myeloproliferative disorders) are not considered solid tumors.	Solid Tumour	4552	Abnormal mass of tissue that usually does not contain cysts or liquid areas. Solid tumours may be benign (not cancerous), or malignant (cancerous). Different types of solid tumours are named for the type of cells that form them. If tumours are associated with those under the term cancer, these terms should be used.	IMDRF:E1804
C54450	CDRH Health Effect - Clinical Code Terminology	C163003	Non-Malignant Neoplasm	A category that includes benign neoplasms and neoplasms with uncertain malignant potential. The latter are characterized by clinicopathological features that are not benign, including some degree of mild or mild/moderate atypia/dysplasia, but lack overt malignant morphologic characteristics and there is no evidence of metastasis at the time of diagnosis.	Non-malignant Neoplasm	4842	A new and abnormal growth of tissue in a part of the body which is not indicative of malignant disorder. Can include benign tumors.	IMDRF:E1805
C54450	CDRH Health Effect - Clinical Code Terminology	C2890	Bacterial Infection	An acute infectious disorder that is caused by gram positive or gram negative bacteria; representative examples include pneumococcal, streptococcal, salmonella, and meningeal infections.	Bacterial Infection	1735	An acute infectious disorder caused by gram positive or gram negative bacteria.	IMDRF:E1901
C54450	CDRH Health Effect - Clinical Code Terminology	C172076	Drug Resistant Bacterial Infection	A bacterial infection that is resistant to antibiotics and antimicrobials.	Drug Resistant Bacterial Infection	4553	An infection that is resistant to antibiotics and antimicrobials, for example, MRSA or VRE.	IMDRF:E190101
C54450	CDRH Health Effect - Clinical Code Terminology	C50719	Pyogenic Infection	An infection caused by pus-producing organisms.	Pyogenic Infection	4554	An infection caused by pus-producing organisms.	IMDRF:E190102
C54450	CDRH Health Effect - Clinical Code Terminology	C50780	Bacterial Toxemia	The condition resulting from the spread of bacterial products (toxins) by the bloodstream.	Toxemia	2207	The condition resulting from the spread of bacterial products (toxins) by the bloodstream.	IMDRF:E190103
C54450	CDRH Health Effect - Clinical Code Terminology	C3245	Fungal Infection	An infection caused by a fungus.	Fungal Infection	2419	An infection caused by a fungus.	IMDRF:E1902
C54450	CDRH Health Effect - Clinical Code Terminology	C3365	Sexually Transmitted Disorder	A disorder acquired through sexual contact.	Sexually Transmitted Infection	4555	A disease acquired predominantly through sexual contact.	IMDRF:E1903
C54450	CDRH Health Effect - Clinical Code Terminology	C50758	Subclinical Infection	Infection associated with no detectable symptoms but caused by microorganisms capable of producing easily recognizable diseases, such a poliomyelitis or mumps.	Subclinical Infection	2247	Infection associated with no detectable signs or symptoms but caused by microorganisms capable of producing easily recognizable diseases.	IMDRF:E1904
C54450	CDRH Health Effect - Clinical Code Terminology	C128346	Transmissible Spongiform Encephalopathy	A transmissible, infectious disease that is caused by a protein that is able to induce abnormal folding of normal cellular proteins, leading to characteristic spongiform brain changes, which are associated with neuronal loss without an inflammatory response. Such disorders have typically long incubation periods, but are then generally rapidly progressive and are uniformly fatal.	Transmissible Spongiform Encephalopathy(TSE)	4556	A group of rare degenerative brain disorders associated with orions for example Creutzfeldt-Jakob disease (CJD) or Bovine Spongiform Encephalopathy (BSE).	IMDRF:E1905
C54450	CDRH Health Effect - Clinical Code Terminology	C26726	Infectious Disorder	A disorder resulting from the presence and activity of a microbial, viral, fungal, or parasitic agent. It can be transmitted by direct or indirect contact.	Unspecified Infection	1930	The report describes a non-specific or unidentified infection. Note: Please use the appropriate term if the report describes a specific infection. i.e. Bacterial Infection E1901, Fungal Infection E1902, Viral Infection E1907, or a relevant Level 3 term where more detail is available.	IMDRF:E1906
C54450	CDRH Health Effect - Clinical Code Terminology	C3439	Viral Infection	Any disease caused by a virus.	Viral Infection	2248	Any disease caused by a virus.	IMDRF:E1907
C54450	CDRH Health Effect - Clinical Code Terminology	C14196	Cytomegalovirus	A genus of the family herpesviridae, subfamily betaherpesvirinae, infecting the salivary glands, liver, spleen, lungs, eyes, and other organs, in which they produce characteristically enlarged cells with intranuclear inclusions.	Cytomegalovirus (CMV) Infection	2220	A genus of the family herpesviridae, subfamily betaherpesvirinae, infecting the salivary glands, liver, spleen, lungs, eyes, and other organs, in which they produce characteristically enlarged cells with intranuclear inclusions.	IMDRF:E190701
C54450	CDRH Health Effect - Clinical Code Terminology	C50472	Bone Shedding Debris	Shedding of accumulated bone fragments.	Bone Shedding Debris	4557	Shedding of accumulated bone fragments.	IMDRF:E2001
C54450	CDRH Health Effect - Clinical Code Terminology	C37921	Bruise	Injury of the soft tissues or bone without breaking the skin that is characterized by blood leakage into the surrounding area.	Bruise/Contusion	1754	Injury of the soft tissues without breaking the skin that is characterized by blood leakage into the surrounding area.	IMDRF:E2002
C54450	CDRH Health Effect - Clinical Code Terminology	C36290	Chemical Exposure	Contact with a chemical substance through touch, inhalation, or ingestion.	Chemical Exposure	2570	Contact with a chemical substance through touch, inhalation, or ingestion.	IMDRF:E2003
C54450	CDRH Health Effect - Clinical Code Terminology	C35375	Crush Injury	Traumatic compression of the body or a part of the body.	Crushing Injury	1797	Traumatic compression of the body or a part of the body.	IMDRF:E2004
C54450	CDRH Health Effect - Clinical Code Terminology	C119027	Easy Bruising	Appearance of skin bruises following perceived minimal contact or injury.	Easy Bruising	4558	Appearance of bruises spontaneously or following minimal contact.	IMDRF:E2005
C54450	CDRH Health Effect - Clinical Code Terminology	C50443	Erosion	An eating away or breakdown of any type of external or internal human tissue including but not limited to skin, teeth, mucosa, or somatic, which involves only the outer tissue layer. When tissue surrounds an implanted device, the tissue breakdown may result in migration and loss of the implant material and may result in further complications such as infection or abscess.	Erosion	1750	An eating away or breakdown of any type of external or internal human tissue including but not limited to skin, teeth, mucosa, or somatic, which involves only the outer tissue layer. When tissue surrounds an implanted device, the tissue breakdown may result in migration and loss of the implant material and may result in further complications such as infection or abscess.	IMDRF:E2006
C54450	CDRH Health Effect - Clinical Code Terminology	C50558	Fall	A sudden movement downward, usually resulting in injury.	Fall	1848	A sudden movement downward, usually resulting in injury.	IMDRF:E2007
C54450	CDRH Health Effect - Clinical Code Terminology	C34620	Foreign Body	Extraneous material within the body.	Foreign Body In Patient	2687	An occurrence where any object including device or fragments is left unintentionally in the body.	IMDRF:E2008
C54450	CDRH Health Effect - Clinical Code Terminology	C62946	Device Fragments in Patient	Issue associated with the inability to retrieve device and/or device fragments during medical procedures.	Device Embedded In Tissue or Plaque	3165	Device and/or fragments of device are embedded in patient's tissue and/or plaque.	IMDRF:E200801
C54450	CDRH Health Effect - Clinical Code Terminology	C50446	Laceration	A cut or tear in any tissue.	Laceration(s)	1946	A cut or tear in any tissue.	IMDRF:E2009
C54450	CDRH Health Effect - Clinical Code Terminology	C50665	Needlestick Puncture	A penetrating stab wound from a needle (or other sharp object) that may result in exposure to blood or other body fluids.	Needle Stick/Puncture	2462	A penetrating stab wound from a needle (or other sharp object) that may result in exposure to blood or other body fluids.	IMDRF:E2010
C54450	CDRH Health Effect - Clinical Code Terminology	C50548	Physical Entrapment	Patient becomes entangled or caught in a bed, particularly in side rails, or mattress, or head/foot boards.	Physical Entrapment	2327	Patient becomes entangled or trapped in a device.	IMDRF:E2011
C54450	CDRH Health Effect - Clinical Code Terminology	C50705	Posttraumatic Wound Infection	Infection of a wound following trauma.	Post Traumatic Wound Infection	2447	Infection of a wound following trauma. This does not include post surgical wound infection.	IMDRF:E2012
C54450	CDRH Health Effect - Clinical Code Terminology	C9445	Rupture	Forcible tearing or disruption of tissue.	Rupture	2208	Forcible tearing or disruption of tissue.	IMDRF:E2013
C54450	CDRH Health Effect - Clinical Code Terminology	C61375	Tissue Breakdown	A process caused by injury or disease or aging and characterized by a partial/complete disruption of tissue. The disruption may be temporary or permanent and may be associated with either (1) impairment or (2) loss of function of the affected organ(s) or system(s).	Tissue Breakdown	2681	A process caused by injury or disease or aging and characterized by a partial/complete disruption of tissue. The disruption may be temporary or permanent and may be associated with either (1) impairment or (2) loss of function of the affected organ(s) or system(s).	IMDRF:E2014
C54450	CDRH Health Effect - Clinical Code Terminology	C50706	Pressure Sore	Death of tissue due to external pressure.	Pressure Sores	2326	Death of tissue due to external pressure.	IMDRF:E201401
C54450	CDRH Health Effect - Clinical Code Terminology	C98904	Connective and Soft Tissue Injury	Damage inflicted on the soft tissues and their supporting structures as the direct or indirect result of an external force, with or without disruption of structural continuity.	Unspecified Tissue Injury	4559	The report describes a non-specific injury to the skin or subcutaneous tissue. Note: Please use "Appropriate Term / Code Not Available" if the report describes a specific injury but the relevant term does not exist.	IMDRF:E2015
C54450	CDRH Health Effect - Clinical Code Terminology	C54685	Tissue Adhesion	A fibrous band of tissue that connects normally separate body regions.	Adhesion(s)	1695	A fibrous band of tissue that connects normally separate body regions.	IMDRF:E2101
C54450	CDRH Health Effect - Clinical Code Terminology	C51220	Insufficient Anesthesia	A state of consciousness that permits the formation of explicit and implicit memories while under general anesthesia.	Awareness during Anaesthesia	1707	A state of consciousness that permits the formation of explicit and implicit memories while under general anesthesia.	IMDRF:E2102
C54450	CDRH Health Effect - Clinical Code Terminology	C50683	Device Overstimulation	A level of stimulation delivered by a device that is greater than the intended level.	Device Overstimulation of Tissue	1991	A level of stimulation that is greater than the intended level.	IMDRF:E2103
C54450	CDRH Health Effect - Clinical Code Terminology	C50541	Electric Shock	A brief, unintentional exposure to an electric current, which may result in local tissue damage due to thermal injury or in a cardiac dysrhythmia.	Electric Shock	2554	A shock caused by a brief, unintentional exposure to an electric current from a device.	IMDRF:E2104
C54450	CDRH Health Effect - Clinical Code Terminology	C61392	Shock From Lead	Unintended electric shock from patient leads.	Shock from Patient Lead(s)	3162	Unintended electric shock from patient leads. This includes an electric shock to a healthcare professional or a patient receiving a shock to an incorrect area of their body.	IMDRF:E210401
C54450	CDRH Health Effect - Clinical Code Terminology	C50505	Cross-Patient Exposure to Body Fluids	The patient becomes contaminated from contact with blood/fluids on a device.	Exposure to Body Fluids	1745	Exposed to or contacted with blood or body fluids of another person.	IMDRF:E2105
C54450	CDRH Health Effect - Clinical Code Terminology	C171975	External Prosthetic Device Pain	Pain that is associated with an external artificial replacement device.	External Prosthetic Device Pain	4560	Pain that is associated with an external artificial replacement device.	IMDRF:E2106
C54450	CDRH Health Effect - Clinical Code Terminology	C50603	Implant Failure	Malfunction of a medical implant.	Failure of Implant	1924	Malfunction of a medical implant.	IMDRF:E2107
C54450	CDRH Health Effect - Clinical Code Terminology	C50417	Failure To Anastomose	Failure of a surgically-induced connection between tubular structures in the body.	Failure to Anastomose	1028	Failure of a surgically-induced connection between tubular structures in the body.	IMDRF:E2108
C54450	CDRH Health Effect - Clinical Code Terminology	C171991	Implant Pain	Pain localized to the site of the implanted device.	Implant Pain	4561	Pain localized to the site of the implanted device.	IMDRF:E2109
C54450	CDRH Health Effect - Clinical Code Terminology	C50605	Inadequate Pain Relief	Continuing discomfort due to a failure of current treatment.	Inadequate Pain Relief	2388	Continuing discomfort due to a lack or failure of a medical approach to treat pain.	IMDRF:E2110
C54450	CDRH Health Effect - Clinical Code Terminology	C3508	Injection Site Reaction	An intense reaction (usually immunologic) developing at the site of injection	Injection Site Reaction	4562	An intense reaction (usually immunologic) developing at the site of injection	IMDRF:E2111
C54450	CDRH Health Effect - Clinical Code Terminology	C50619	Intraoperative Pain	Pain occurring during a surgical operation.	Intraoperative Pain	2662	Pain occurring during a surgical operation.	IMDRF:E2112
C54450	CDRH Health Effect - Clinical Code Terminology	C50850	Oversedated	A level of sedation that is greater than the intended level.	Oversedation	1990	A level of sedation that is greater than the intended level.	IMDRF:E2113
C54450	CDRH Health Effect - Clinical Code Terminology	C4080	Perforation	A hole or opening made through a membrane or other tissue or material.	Perforation	2001	A hole or opening made through a membrane or other tissue or material.	IMDRF:E2114
C54450	CDRH Health Effect - Clinical Code Terminology	C50679	Organ Perforation	A rupture in an organ(s) due to traumatic or pathologic processes.	Internal Organ Perforation	1987	A rupture in the organ(s) due to traumatic or pathologic processes.	IMDRF:E211401
C54450	CDRH Health Effect - Clinical Code Terminology	C50704	Postoperative Wound Infection	Infection of a surgical skin incision.	Post Operative Wound Infection	2446	Infection of a surgical skin incision.	IMDRF:E2115
C54450	CDRH Health Effect - Clinical Code Terminology	C50723	Radiation Sickness Syndrome	The complex of symptoms characterizing the disease known as radiation injury, resulting from excessive exposure (greater than 200 rads or 2 gray) of the whole body (or large part) to ionizing radiation. The earliest of these symptoms are nausea, fatigue, vomiting, and diarrhea, which may be followed by epilation, hemorrhage, inflammation of the mouth and throat, and general loss of energy. In severe cases, where the radiation exposure has been approximately 1000 Rad (10 gray) or more, death may occur within two to four weeks. Those who survive six weeks after the receipt of a single large dose of radiation to the whole body may generally be expected to recover. (U.S. Nuclear Regulatory Commission).	Radiation Sickness Syndrome	2256	The complex of symptoms characterizing the disease known as radiation injury, resulting from excessive exposure of the whole body (or large part) to ionizing radiation.	IMDRF:E2116
C54450	CDRH Health Effect - Clinical Code Terminology	C50784	Twiddler's Syndrome	Dislodgement, breakdown, or other malfunction of an artificial cardiac pacemaker, chemotherapy port, drip infusion valve, or similar implanted diagnostic or therapeutic device as a result of unconscious or habitual manipulation by the patient.	Twiddlers Syndrome	4563	Dislodgement, breakdown, or other malfunction of an artificial cardiac pacemaker, chemotherapy port, drip infusion valve, or similar implanted diagnostic or therapeutic device as a result of unconscious or habitual manipulation by the patient.	IMDRF:E2117
C54450	CDRH Health Effect - Clinical Code Terminology	C172077	Unintended Extubation	The removal of a previously inserted tube from a hollow organ or passageway, often from the airway.	Unintended Extubation	4564	The removal of a previously inserted tube from a hollow organ or passageway, often from the airway.	IMDRF:E2118
C54450	CDRH Health Effect - Clinical Code Terminology	C61401	Unintended Radiation Exposure	The unintentional exposure to radiation of a person.	Unintended Radiation Exposure	4565	The unintentional exposure to radiation of a person, or a part of a persons body. This might include exposure of a healthcare professional, or the exposure of the wrong part of the body of a patient who was intended to receive therapeutic or diagnostic radiation. This includes both ionizing and non ionizing radiation.	IMDRF:E2119
C54450	CDRH Health Effect - Clinical Code Terminology	C177438	Bone Cement Implantation Syndrome	A rare and potentially fatal perioperative complication of cemented bone surgery, characterized by hypotension, hypoxia, cardiac dysrhythmias, and in severe cases cardiac arrest.	Bone Cement Implantation Syndrome	4583	A rare and potentially fatal perioperative complication of cemented bone surgery, characterised by hypotension, hypoxia, cardiac dysrhythmias, and in severe cases cardiac arrest.	IMDRF:E2120
C54450	CDRH Health Effect - Clinical Code Terminology	C187282	Endoleak	Persistent blood flow/pressure in the aneurysm sac following an endovascular aneurysm repair (EVAR) procedure.	Endoleaks	4843	Persistent blood flow/pressure in the aneurysm sac following an endovascular aneurysm repair (EVAR) procedure.	IMDRF:E2121
C54450	CDRH Health Effect - Clinical Code Terminology	C35024	Sinusitis	An acute or chronic inflammatory process affecting the mucous membranes of any sinus cavity.	Sinusitis	4844	Inflammation (swelling and redness) of the paranasal sinuses, associated or related to implantation procedures or devices.	IMDRF:E2122
C54450	CDRH Health Effect - Clinical Code Terminology	C187373	Peri-prosthetic Joint Infection	Infection around an implant following joint replacement.	Peri-prosthetic Joint Infection	4845	Infection around an implant following joint replacement.	IMDRF:E2123
C54450	CDRH Health Effect - Clinical Code Terminology	C50447	Abnormal Blood Gas Measurement	Arterial blood gas test results that are outside normal limits.	Abnormal Blood Gases	1034	Abnormal Blood Gas Measurements.	IMDRF:E2201
C54450	CDRH Health Effect - Clinical Code Terminology	C50584	High Blood Oxygen Saturation	A high level of the degree to which oxygen is bound to hemoglobin given as a percentage calculated by dividing the maximum oxygen capacity into the actual oxygen content and multiplying by 100. Oxygen saturation usually is measured using pulse oximetry.	High Oxygen Saturation	2478	A high level of the degree to which oxygen is bound to hemoglobin given as a percentage calculated by dividing the maximum oxygen capacity into the actual oxygen content and multiplying by 100. Oxygen saturation usually is measured using pulse oximetry.	IMDRF:E2202
C54450	CDRH Health Effect - Clinical Code Terminology	C50640	Low Blood Oxygen Saturation	A low level of the degree to which oxygen is bound to hemoglobin given as a percentage calculated by dividing the maximum oxygen capacity into the actual oxygen content and multiplying by 100. Oxygen saturation usually is measured using pulse oximetry.	Low Oxygen Saturation	2477	A low level of the degree to which oxygen is bound to hemoglobin given as a percentage calculated by dividing the maximum oxygen capacity into the actual oxygen content and multiplying by 100. Oxygen saturation usually is measured using pulse oximetry.	IMDRF:E2203
C54450	CDRH Health Effect - Clinical Code Terminology	C161592	Elevated LDH	An indication that the concentration of lactate dehydrogenase found in a sample is higher than previous noted or above the normal range.	Lactate Dehydrogenase Increased	4567	A laboratory test result indicating an increase in the lactate dehydrogenase concentration of a biological sample.	IMDRF:E2204
C54450	CDRH Health Effect - Clinical Code Terminology	C102993	Bacteremia	A laboratory test result that indicates the presence of bacteria in the blood.	Bacteremia	4846	Condition that relates to the presence of viable bacteria in the bloodstream, whether associated with active disease or not.	IMDRF:E2205
C54450	CDRH Health Effect - Clinical Code Terminology	C187380	High Metal Ion Levels	High blood or serum levels of ions which are attributed to one or more medical devices used, such as but not limited to Co, Cr, Ti, Ni, Mo.	High metal ion levels	4847	High blood or serum levels of ions which are attributed to one or more medical devices used, such as but not limited to Co, Cr, Ti, Ni, Mo.	IMDRF:E2206
C54450	CDRH Health Effect - Clinical Code Terminology	C187381	Radiolucent Lines	An xray finding that indicates a void or area of tissue that is less dense. Radiolucent lines can be prognostic factors after surgical joint replacements.	Radiolucent Lines	4848	Radiolucencies observed on x-ray.	IMDRF:E2207
C54450	CDRH Health Effect - Clinical Code Terminology	C7941	Body Temperature Associated Symptom	An alteration in body temperature outside the normal range.	Alteration in Body Temperature	4568	A Change or alteration of Body Temperature to a temperature outside the range of normal body temperature.	IMDRF:E2301
C54450	CDRH Health Effect - Clinical Code Terminology	C3038	Fever	Elevation of body temperature above normal due to inflammatory or immune responses.	Fever	1858	Elevation of body temperature above normal due to the bodies own responses.	IMDRF:E230101
C54450	CDRH Health Effect - Clinical Code Terminology	C50589	Hyperthermia	A condition characterized by an abnormally high body temperature. In a hyperthermic state, the hypothalamic set-point is normal but body temperature increases and overrides the ability to lose heat, resulting from exogenous heat exposure or endogenous heat production.	Hyperthermia	1909	An abnormally high body temperature. Not fever.	IMDRF:E230102
C54450	CDRH Health Effect - Clinical Code Terminology	C50523	Decreased Core Body Temperature	Abnormally low body temperature.	Hypothermia	1915	Abnormally low body temperature.	IMDRF:E230103
C54450	CDRH Health Effect - Clinical Code Terminology	C50458	Ambulation Difficulty	Any persistent problem with walking.	Ambulation Difficulties	2544	Any persistent problem with walking or gait.	IMDRF:E2302
C54450	CDRH Health Effect - Clinical Code Terminology	C50478	Capsular Contracture	The tightening of scar tissue that forms around the implant.	Capsular Contracture	1761	The tightening of scar tissue that forms around the implant.	IMDRF:E2303
C54450	CDRH Health Effect - Clinical Code Terminology	C35143	Chills	Shivering or moderate tremors of the body often accompanied by a cold sensation.	Chills	2191	Shivering or moderate tremors of the body often accompanied by a cold sensation.	IMDRF:E2304
C54450	CDRH Health Effect - Clinical Code Terminology	C26737	Cyanosis	A bluish or purplish discoloration of the skin and mucous membranes resulting from a reduced concentration of oxygenated hemoglobin in the blood.	Cyanosis	1798	A bluish or purplish discoloration of the skin and mucous membranes resulting from a reduced amount of oxygenated hemoglobin in the blood.	IMDRF:E2305
C54450	CDRH Health Effect - Clinical Code Terminology	C2875	Anorexia	Loss of appetite.	Decreased Appetite	4569	Lack of desire for food.	IMDRF:E2306
C54450	CDRH Health Effect - Clinical Code Terminology	C113451	Have Increased Appetite	A question about whether an individual has or had increased appetite.	Increased Appetite	4570	Intense desire for food.	IMDRF:E2307
C54450	CDRH Health Effect - Clinical Code Terminology	C50536	Disfigurement	Permanent deformation of appearance.	Deformity/ Disfigurement	2360	An alteration of appearance, shape, size or alignment.	IMDRF:E2308
C54450	CDRH Health Effect - Clinical Code Terminology	C9442	Deposit	Accumulation of extraneous inorganic matter in tissues or cavities.	Deposits	1809	Accumulation of extraneous inorganic matter in tissues or cavities.	IMDRF:E2309
C54450	CDRH Health Effect - Clinical Code Terminology	C3672	Calcification	Deposition of calcium in the tissues. It may be the result of a metabolic disorder or long-standing infection, or it may be associated with the presence of cancer.	Calcium Deposits/Calcification	1758	Deposition of calcium salt in the tissues.	IMDRF:E230901
C54450	CDRH Health Effect - Clinical Code Terminology	C50403	Diaphoretic	Pertaining to, characterized by, or promoting sweating, e.g. procedure or an agent that promotes sweating.	Diaphoresis	2452	Profuse sweating.	IMDRF:E2310
C54450	CDRH Health Effect - Clinical Code Terminology	C50535	Discomfort	A feeling of mental or physical uneasiness, pain, or distress.	Discomfort	2330	A feeling of mental or physical uneasiness, pain, or distress.	IMDRF:E2311
C54450	CDRH Health Effect - Clinical Code Terminology	C3036	Fatigue	Overall tiredness and lack of energy.	Fatigue	1849	A state of generalized weakness with a pronounced inability to summon sufficient energy to accomplish daily activities.	IMDRF:E2312
C54450	CDRH Health Effect - Clinical Code Terminology	C50556	Extreme Exhaustion	Extreme fatigue; inability to respond to stimuli.	Extreme Exhaustion	1843	Extreme fatigue; the inability to respond to stimuli.	IMDRF:E231201
C54450	CDRH Health Effect - Clinical Code Terminology	C3044	Fibrosis	The formation of fibrous tissue.	Fibrosis	3167	The formation of fibrous tissue.	IMDRF:E2313
C54450	CDRH Health Effect - Clinical Code Terminology	C3045	Fistula	Abnormal epithelial-lined communication between two anatomical structures.	Fistula	1862	Abnormal epithelial-lined communication between two anatomical structures.	IMDRF:E2314
C54450	CDRH Health Effect - Clinical Code Terminology	C34548	Fluid Discharge	The pouring forth of a fluid.	Fluid Discharge	2686	Flow or leakage of fluid other than blood, from an orifice, wound or tissue.	IMDRF:E2315
C54450	CDRH Health Effect - Clinical Code Terminology	C50717	Purulent Discharge	Pus-containing fluid that is draining from an orifice or wound.	Purulent Discharge	1812	A flow or draining of pus or exudate from an oriface or wound.	IMDRF:E231501
C54450	CDRH Health Effect - Clinical Code Terminology	C50444	Foreign Body Reaction	A granulomatous inflammatory reaction evoked by the presence of an exogenous material in the tissues, a characteristic feature of which is the formation of foreign body giant cells.	Foreign Body Reaction	1868	An inflammatory reaction evoked by the presence of an exogenous material in the tissues.	IMDRF:E2316
C54450	CDRH Health Effect - Clinical Code Terminology	C3064	Granuloma	An inflammatory reaction usually caused by infectious organisms, foreign bodies, or cholesterol deposits. It is characterized by the presence of epithelioid histiocytes and chronic inflammation.	Granuloma	1876	An inflammatory reaction usually caused by infectious organisms, foreign bodies, or cholesterol deposits. It is characterized by the presence of epithelioid histiocytes and chronic inflammation.	IMDRF:E2317
C54450	CDRH Health Effect - Clinical Code Terminology	C50575	Alopecia	Hair loss usually from the scalp. It may result in bald spots or spread to the entire scalp or the entire epidermis. It may be androgenetic or caused by chemotherapeutic agents, compulsive hair pulling, autoimmune disorders or congenital conditions.	Hair Loss	1877	Loss of hair usually from the scalp that may result in bald spots or spread to the entire scalp or epidermis.	IMDRF:E2318
C54450	CDRH Health Effect - Clinical Code Terminology	C34685	Hernia	The protrusion of part of an organ or fibroadipose tissue through an abnormal opening.	Hernia	2240	The protrusion of part of an organ or fibroadipose tissue through an opening or weakened area.	IMDRF:E2319
C54450	CDRH Health Effect - Clinical Code Terminology	C3117	Hypertension	Blood pressure that is abnormally high.	High Blood Pressure/ Hypertension	1908	Blood pressure that is abnormally high.	IMDRF:E2320
C54450	CDRH Health Effect - Clinical Code Terminology	C3128	Hypotension	Blood pressure that is abnormally low.	Low Blood Pressure/ Hypotension	1914	Blood pressure that is abnormally low.	IMDRF:E2321
C54450	CDRH Health Effect - Clinical Code Terminology	C50588	Hyperemia	The presence of an increased amount of blood in a part or organ; engorgement.	Hyperemia	1904	The presence of an increased amount of blood in a part or organ; engorgement.	IMDRF:E2322
C54450	CDRH Health Effect - Clinical Code Terminology	C3113	Hyperplasia	An abnormal increase in the number of cells in an organ or a tissue with consequent enlargement.	Hyperplasia	1906	An abnormal increase in the number of cells in an organ or a tissue with consequent enlargement.	IMDRF:E2323
C54450	CDRH Health Effect - Clinical Code Terminology	C3429	Incontinence	Involuntary passage of stool or urine from the body.	Incontinence	1928	Involuntary passage of feces and/or urine from the body.	IMDRF:E2324
C54450	CDRH Health Effect - Clinical Code Terminology	C78498	Fecal Incontinence	Involuntary passage of stool from the rectum.	Fecal Incontinence	4571	Inability to control voluntary passage of feces from the body.	IMDRF:E232401
C54450	CDRH Health Effect - Clinical Code Terminology	C78497	Urinary Incontinence	Involuntary passage of urine outside the body.	Urinary Incontinence	4572	Inability to control voluntary passage of urine from the body.	IMDRF:E232402
C54450	CDRH Health Effect - Clinical Code Terminology	C25754	Infiltration	The process of the diffusion or accumulation in a tissue or cells of a substance not normal to it or in amounts above normal. (NCI)	Infiltration into Tissue	1931	Permeation of foreign substances into tissues or cells.	IMDRF:E2325
C54450	CDRH Health Effect - Clinical Code Terminology	C3137	Inflammation	A finding of a localized protective response resulting from injury or destruction of tissues. Inflammation serves to destroy, dilute, or wall off both the injurious agent and the injured tissue. In the acute phase, inflammation is characterized by the signs of pain, heat, redness, swelling, and loss of function. Histologically, inflammation involves a complex series of events, including dilatation of arterioles, capillaries, and venules, with increased permeability and blood flow; exudation of fluids, including plasma proteins; and leukocyte migration into the site of inflammation.	Inflammation	1932	A localized physical condition in which part of the body becomes reddened, swollen, or hot and often painful.	IMDRF:E2326
C54450	CDRH Health Effect - Clinical Code Terminology	C16897	Necrotic Process	A cell death process that is morphologically characterized by a gain in cell volume (oncosis), swelling of organelles, plasma membrane rupture and subsequent loss of intracellular contents.	Necrosis	1971	The pathologic death of cells or of a portion of tissue or organ resulting from irreversible damage.	IMDRF:E2327
C54450	CDRH Health Effect - Clinical Code Terminology	C3284	Obstruction	Blockage of the normal flow of the contents of an anatomical passageway.	Obstruction/Occlusion	2422	Blockage or closing of the normal flow of the contents of an anatomical passageway.	IMDRF:E2328
C54450	CDRH Health Effect - Clinical Code Terminology	C50527	Dehiscence	A splitting open of an anatomical structure, zone, or organ with the exposure or discharge of its content.	Organ Dehiscence	2502	A splitting open or rupture of an internal organ with the exposure or discharge of its content.	IMDRF:E2329
C54450	CDRH Health Effect - Clinical Code Terminology	C3303	Pain	The sensation of discomfort, distress, or agony, resulting from the stimulation of specialized nerve endings.	Pain	1994	An unpleasant sensory and emotional experience that is associated with actual or potential tissue damage or described in such terms.	IMDRF:E2330
C54450	CDRH Health Effect - Clinical Code Terminology	C38665	Chest Pain	Pain in the chest.	Chest Pain	1776	Pain in the chest.	IMDRF:E233001
C54450	CDRH Health Effect - Clinical Code Terminology	C50685	Pallor	An unusual or extreme paleness, state of decreased skin or mucosal coloration.	Pallor	2468	Unhealthy, pale or white appearance of the face.	IMDRF:E2331
C54450	CDRH Health Effect - Clinical Code Terminology	C172019	Physical Asymmetry	Lack or absence of balanced proportions between parts or organs of the body.	Physical Asymmetry	4573	Lack or absence of balanced proportions between parts or organs of the body.	IMDRF:E2332
C54450	CDRH Health Effect - Clinical Code Terminology	C36173	Prolapse	A condition in which an organ or body tissue drops or bulges out of place.	Prolapse	2475	A condition in which an organ or body tissue drops or bulges out of place.	IMDRF:E2333
C54450	CDRH Health Effect - Clinical Code Terminology	C27298	Ptosis	The drooping of the upper eyelid.	Ptosis	2620	The drooping or downward displacement of a body part.	IMDRF:E2334
C54450	CDRH Health Effect - Clinical Code Terminology	C172024	Reaction to Medicinal Component of Device	Any local or systemic adverse reaction to the medicinal component of a combination product.	Reaction to Medicinal Component of Device	4574	Any local or systemic adverse reaction to the medicinal component of a combination product.	IMDRF:E2335
C54450	CDRH Health Effect - Clinical Code Terminology	C35016	Shock	A life-threatening condition that requires immediate medical intervention. It is characterized by reduced blood flow that may result in damage of multiple organs. Types of shock include cardiogenic, hemorrhagic, septic, anaphylactic, and traumatic shock.	Shock	2072	A life-threatening condition that requires immediate medical intervention. It is characterized by reduced blood flow that may result in damage of multiple organs.	IMDRF:E2336
C54450	CDRH Health Effect - Clinical Code Terminology	C50482	Cardiogenic Shock	Shock resulting from primary failure of the heart in its pumping function, as in myocardial infarction, severe cardiomyopathy, or mechanical obstruction or compression of the heart.	Cardiogenic Shock	2262	Shock resulting from primary failure of the heart in its pumping function, as in myocardial infarction, severe cardiomyopathy, or mechanical obstruction or compression of the heart.	IMDRF:E233601
C54450	CDRH Health Effect - Clinical Code Terminology	C50615	Insulin Shock	A hypoglycemic reaction to overdosage of insulin, a skipped meal, or strenuous exercise in an insulin-dependent diabetic.	Hypoglycemic Shock	4575	A hypoglycemic reaction to overdosage of insulin, a skipped meal, or strenuous exercise in an insulin-dependent diabetic.	IMDRF:E233602
C54450	CDRH Health Effect - Clinical Code Terminology	C50596	Hypovolemic Shock	Shock resulting from insufficient blood volume for the maintenance of adequate cardiac output, blood pressure and tissue perfusion.	Hypovolemic Shock	1917	Shock resulting from insufficient blood volume for the maintenance of adequate cardiac output, blood pressure and tissue perfusion.	IMDRF:E233603
C54450	CDRH Health Effect - Clinical Code Terminology	C50671	Neurogenic Shock	Shock resulting from neurogenic vasodilation, which can be produced by cerebral trauma or hemorrhage, spinal cord injury, deep general or spinal anesthesia, or toxic central nervous system depression.	Neurogenic Shock	2265	Shock resulting from neurogenic vasodilation, which can be produced by cerebral trauma or hemorrhage, spinal cord injury, deep general or spinal anesthesia, or toxic central nervous system depression.	IMDRF:E233604
C54450	CDRH Health Effect - Clinical Code Terminology	C35018	Septic Shock	A state of acute circulatory failure characterized by persistent arterial hypotension despite adequate fluid resuscitation or by tissue hypoperfusion unexplained by other causes.	Septic Shock	2068	A state of acute circulatory failure resulting from organ injury or damage in response to infection that results in dangerously low blood pressure.	IMDRF:E233605
C54450	CDRH Health Effect - Clinical Code Terminology	C50754	Stenosis	Narrowing or stricture of a vessel, duct or canal.	Stenosis	2263	Narrowing or stricture of a vessel, duct or canal.	IMDRF:E2337
C54450	CDRH Health Effect - Clinical Code Terminology	C172029	Restenosis	The reoccurrence of stenosis after it has been treated.	Restenosis	4576	The reoccurrence of stenosis after it has been treated.	IMDRF:E233701
C54450	CDRH Health Effect - Clinical Code Terminology	C3002	Edema	Accumulation of an excessive amount of fluid in cells or intercellular tissues.	Swelling/ Edema	4577	Enlargement or expansion in size of a body part from injury or inflammation.	IMDRF:E2338
C54450	CDRH Health Effect - Clinical Code Terminology	C78262	Edema Limbs	Swelling due to an excessive accumulation of fluid in the upper or lower extremities.	Peripheral Edema	4578	accumulation of fluid in tissues perfused by the peripheral vascular system.	IMDRF:E233801
C54450	CDRH Health Effect - Clinical Code Terminology	C49052	Joint Effusion	Abnormally increased amount of fluid in a joint cavity, usually as a result of joint inflammation.	Joint effusion	4849	An abnormal collection of fluid in hollow spaces or between tissues of the joints.	IMDRF:E233802
C54450	CDRH Health Effect - Clinical Code Terminology	C3426	Ulcer	A circumscribed inflammatory and often suppurating lesion on the skin or an internal mucous surface resulting in necrosis of tissue.	Ulcer	2274	An open sore on an external or internal surface of the body caused by a break in the skin or mucous membrane that fails to heal.	IMDRF:E2339
C54450	CDRH Health Effect - Clinical Code Terminology	C50863	Wound Dehiscence	Splitting of the sutured margins of a surgical wound. Risk factors include diabetes mellitus, obesity, and advanced age.	Wound Dehiscence	1154	A complication in which the wound splits or separates after being surgically closed.	IMDRF:E2340
C54450	CDRH Health Effect - Clinical Code Terminology	C171967	Double Capsule	The presence of two distinct capsular layers around an implant with an intercapsular space of the breast.	Double Capsule	4579	The presence of two distinct capsular layers around an implant with an intercapsular space	IMDRF:E2341
C54450	CDRH Health Effect - Clinical Code Terminology	C75568	Multiple Organ Failure	Complete impairment of two or more organs or organ systems.	Multiple Organ Failure	3261	Complete impairment of two or more organs or organ systems.	IMDRF:E2342
C54450	CDRH Health Effect - Clinical Code Terminology	C172137	Insufficient Information to Classify Condition	Not enough information available to classify the clinical signs, symptoms and conditions.	Insufficient Information	4580	Health effect appears to have occurred but there is not yet enough information available to classify the clinical signs, symptoms and conditions.	IMDRF:E2401
C54450	CDRH Health Effect - Clinical Code Terminology	C172078	Appropriate Clinical Signs, Symptoms, Conditions Term/Code Not Available	The clinical signs, symptoms and conditions are not adequately described by any other term.	Appropriate Term / Code Not Available	4581	The clinical signs, symptoms and conditions are not adequately described by any other term. Note: this code must not be used unless there is no other feasible code. The preferred term should be documented when submitting an adverse event report. This information will be used to determine if a new term should be added to the code table.	IMDRF:E2402
C54450	CDRH Health Effect - Clinical Code Terminology	C106101	Absence of Signs or Symptoms	Absence of detectable signs or symptoms.	No Clinical Signs, Symptoms or Conditions	4582	No patient involvement or, no observable clinical symptoms or a change in symptoms is identified in the patient.	IMDRF:E2403
C171094	CDRH Health Effect - Impact Code Terminology	C171956	Change in Therapeutic Response	Change in response to treatment or cure of a disorder or disease.	Change in Therapeutic Response	4601	Change in response to treatment or cure of a disorder or disease.	IMDRF:F01
C171094	CDRH Health Effect - Impact Code Terminology	C50526	Decreased Therapeutic Response	A reduction in the desirable and beneficial effects resulting from a medical  treatment.	Therapeutic Response Decreased	2271	A reduction in the desirable and beneficial effects resulting from a medical treatment.	IMDRF:F0101
C171094	CDRH Health Effect - Impact Code Terminology	C50611	Increased Therapeutic Response	An increase in the desirable and beneficial effects resulting from a medical  treatment.	Therapeutic Response Increased	2272	An increase in the desirable and beneficial effects resulting from a medical treatment.	IMDRF:F0102
C171094	CDRH Health Effect - Impact Code Terminology	C50789	Unexpected Therapeutic Effect	Unanticipated desirable and beneficial effects resulting from a medical  treatment.	Unexpected Therapeutic Effects	2099	Unanticipated desirable and beneficial effects resulting from a medical treatment.	IMDRF:F0103
C171094	CDRH Health Effect - Impact Code Terminology	C28554	Dead	The cessation of life.	Death	1802	The cessation of life.	IMDRF:F02
C171094	CDRH Health Effect - Impact Code Terminology	C50620	Intrauterine Fetal Death	Death of a fetus after 10 weeks gestation.	Intrauterine Fetal Death	1855	Death in utero; failure of the product of conception to show evidence of respiration, heart beat, or definite movement of a voluntary muscle after expulsion from the uterus, with no possibility of resuscitation.	IMDRF:F0201
C171094	CDRH Health Effect - Impact Code Terminology	C116340	Brain Death	Irreversible absence of cortical and brain stem functioning.	Brain Death	4602	The cessation of life due to permanent loss of brain function and brainstem for absence of responsiveness to external stimuli, absence of reflex and apnea.	IMDRF:F03
C171094	CDRH Health Effect - Impact Code Terminology	C171962	Delay to Diagnosis due to Device	Patient diagnosis was clinically significant delayed as a consequence of device performance.	Delay to Diagnosis	4603	Patient diagnosis was clinically significant delayed as a consequence of device performance.	IMDRF:F04
C171094	CDRH Health Effect - Impact Code Terminology	C171963	Delay to Treatment due to Device	Patient treatment was delayed as a consequence of device performance.	Delay to Treatment/ Therapy	4604	Patient treatment was delayed as a consequence of device performance.	IMDRF:F05
C171094	CDRH Health Effect - Impact Code Terminology	C171966	Disruption of Subsequent Medical Procedure due to Device	Situation in which the use of the device impedes or affects a subsequent medical procedure or use of a medicine or device.	Disruption of Subsequent Medical Procedure	4605	Situation in which the use of the device impedes or affects a subsequent medical procedure or use of a medicine or device. The time elapsed between the use of the device and the medical procedure is not a factor. It is not necessary for the device to have broken or malfunctioned.	IMDRF:F06
C171094	CDRH Health Effect - Impact Code Terminology	C171974	Exacerbation of Existing Condition due to Device	Use of the device has lead to worsening of the existing disease or condition.	Exacerbation of Existing Condition	4606	Use of the device has lead to worsening of the existing disease or condition.	IMDRF:F07
C171094	CDRH Health Effect - Impact Code Terminology	C171989	Hospitalization or Prolonged Hospitalization due to Device	Hospitalization or prolonged hospitalization due to the health damage accompanying the use of device.	Hospitalization or Prolonged Hospitalization	4607	Hospitalization or prolonged hospitalization due to the health damage accompanying the use of device.	IMDRF:F08
C171094	CDRH Health Effect - Impact Code Terminology	C171998	Intensive Care Stay Required	Patient requires admission to or extension of stay in an intensive care unit.	Intensive Care	4608	Patient requires admission to or extension of stay in an intensive care unit.	IMDRF:F0801
C171094	CDRH Health Effect - Impact Code Terminology	C171977	Fetal Harm	Fetal distress, congenital physical or mental impairment or birth defect, excluding fetal death.	Fetal Harm	4609	Fetal distress, congenital physical or mental impairment or birth defect, excluding fetal death.	IMDRF:F09
C171094	CDRH Health Effect - Impact Code Terminology	C171994	Inadequate/Inappropriate Treatment or Diagnostic Exposure due to Device	Patient did not receive intended treatment from a device or received inadequate treatment as a consequence of device performance.	Inadequate/Inappropriate Treatment or Diagnostic Exposure	4610	Patient did not receive intended treatment from a device or received inadequate treatment as a consequence of device performance. This includes inadequate/inappropriate radiation dosage during procedures.	IMDRF:F10
C171094	CDRH Health Effect - Impact Code Terminology	C172014	No Treatment due to Device Malfunction	Patient treatment was absent as a consequence of device performance.	Absence of Treatment	4611	Patient treatment was absent as a consequence of device performance.	IMDRF:F1001
C171094	CDRH Health Effect - Impact Code Terminology	C172090	Incompatible Blood Transfusion	Receiving incorrect or incompatible whole blood or a blood component.	Incompatible Blood Transfusion	4612	Receiving incorrect or incompatible whole blood or a blood component.	IMDRF:F1002
C171094	CDRH Health Effect - Impact Code Terminology	C50429	Missed Dose	A dose of medicine that was not taken at the prescribed dosing interval.	Missed Dose	2561	A dose of medicine was not taken or delivered at the prescribed dosing interval.	IMDRF:F1003
C171094	CDRH Health Effect - Impact Code Terminology	C50428	Underdose	An inadequate amount of a treatment.	Underdose	2542	Exposure to, or intake of, an insufficient amount of a substance.	IMDRF:F1004
C171094	CDRH Health Effect - Impact Code Terminology	C52354	Radiation Underdose	An inadequate amount of a radiation treatment.	Radiation Underdose	2166	A lower than intended dose of radiation to a single field.	IMDRF:F100401
C171094	CDRH Health Effect - Impact Code Terminology	C50873	Overdose	Exposure to, or intake of, an excessive amount of a substance.	Overdose	1988	Exposure to, or intake of, an excessive amount of a substance.	IMDRF:F1005
C171094	CDRH Health Effect - Impact Code Terminology	C50862	Radiation Overdose	A higher than intended cumulative dose of radiation to a single field.	Radiation Overdose	1510	A higher than intended cumulative dose of radiation to a single field.	IMDRF:F100501
C171094	CDRH Health Effect - Impact Code Terminology	C187376	Inadequate Treatment/Disease Progression	The worsening of a disease over time due to inadequate treatment.	Inadequate Treatment/Disease Progression	4651	The worsening of a disease over time due to inadequate treatment.	IMDRF:F1006
C171094	CDRH Health Effect - Impact Code Terminology	C187377	Exposure to Contaminated Device/Risk of Infection	Exposure to a non-sterile device or conditions where infection is likely.	Exposure to Contaminated Device/Risk of Infection	4652	Exposure to a non-sterile device or conditions where infection is likely.	IMDRF:F1007
C171094	CDRH Health Effect - Impact Code Terminology	C172008	Minor Injury/ Illness/Impairment	A mild injury, illness or impairment which can be treated with minimal or no intervention.	Minor Injury/ Illness / Impairment	4613	A mild injury, illness or impairment which can be treated with minimal or no intervention.	IMDRF:F11
C171094	CDRH Health Effect - Impact Code Terminology	C172031	Serious Injury/Illness/Impairment	A severe injury, illness or impairment which requires hospitalization or medical intervention.	Serious Injury/ Illness/ Impairment	4614	A severe injury, illness or impairment which requires hospitalization or medical intervention.	IMDRF:F12
C171094	CDRH Health Effect - Impact Code Terminology	C165593	Chronic Disease	A disease condition that persists over a significant span of time.	Chronic Disease	4615	Disease that persists over a long period of time, cannot be prevented by vaccines or cured by medication, nor do they just disappear.	IMDRF:F1201
C171094	CDRH Health Effect - Impact Code Terminology	C21007	Disability	Any physical or mental impairment that interferes with an individual's ability to perform desired activities.	Disability	4616	Any physical or mental impairment that interferes with an individual's ability to perform desired activities.	IMDRF:F1202
C171094	CDRH Health Effect - Impact Code Terminology	C172001	Life Threatening Illness or Injury	Patient suffered an illness or injury which if not treated would be fatal.	Life Threatening Illness or Injury	4617	Patient suffered an illness or injury which if not treated would be fatal.	IMDRF:F1203
C171094	CDRH Health Effect - Impact Code Terminology	C172018	Permanent Impairment	Irreversible deterioration of the state of health.	Permanent Impairment	4618	Irreversible deterioration of the state of health.	IMDRF:F1204
C171094	CDRH Health Effect - Impact Code Terminology	C172038	Temporary Impairment	Reversible deterioration of the state of health.	Temporary Impairment	4619	Reversible deterioration of the state of health.	IMDRF:F1205
C171094	CDRH Health Effect - Impact Code Terminology	C50432	Misdiagnosis	An incorrect diagnosis or classification of an illness or other problem.	Misdiagnosis/ Misclassification	2159	An incorrect diagnosis or classification of an illness or other problem.	IMDRF:F13
C171094	CDRH Health Effect - Impact Code Terminology	C172023	Prolonged Episode of Care	Clinically significant extended treatment time or procedural time.	Prolonged Episode of Care	4620	Clinically significant extended treatment time or procedural time. Not to be used for prolonged hospitalization or prolonged surgery.	IMDRF:F14
C171094	CDRH Health Effect - Impact Code Terminology	C172025	Recognized Device or Procedural Complication	Patient experiencing a complication that is well documented in association with the device or procedure.	Recognised Device or Procedural Complication	4621	Patient experiencing a complication that is well documented in association with the device or procedure.	IMDRF:F15
C171094	CDRH Health Effect - Impact Code Terminology	C172027	Reduction in Life Expectancy	Decrease in lifetime/ lifespan of an individual. Decline in the normal duration or in average life.	Reduction in Life Expectancy	4622	Decrease in lifetime/ lifespan of an individual. Decline in the normal duration or in average life.	IMDRF:F16
C171094	CDRH Health Effect - Impact Code Terminology	C21097	Sedation	The process of allaying nervous excitement or the state of being calmed. (Taber's)	Sedation	2368	Patient required sedation or additional sedation.	IMDRF:F17
C171094	CDRH Health Effect - Impact Code Terminology	C15315	Rehabilitation	Restoration of the ability to function in a normal or near normal manner following disease, illness, or injury.	Rehabilitation	4623	Patient requires treatment to facilitate the process of recovery from injury, illness, or disease.	IMDRF:F18
C171094	CDRH Health Effect - Impact Code Terminology	C15329	Surgical Procedure	A diagnostic or treatment procedure performed by manual and/or instrumental means, often involving an incision and the removal or replacement of a diseased organ or tissue; of or relating to or involving or used in surgery or requiring or amenable to treatment by surgery.	Surgical Intervention	4624	One or more surgical procedures was required, or an existing procedure changed.	IMDRF:F19
C171094	CDRH Health Effect - Impact Code Terminology	C50831	Additional Surgical Procedure	Any surgical procedure performed subsequent to a primary or initial surgical procedure.	Additional Surgery	4625	Surgical intervention that was not planned and needed to be performed in addition to other interventions including surgical ones.	IMDRF:F1901
C171094	CDRH Health Effect - Impact Code Terminology	C15179	Amputation	The surgical removal of all or part of a limb or other appendage.	Amputation	4626	Patient required surgical removal of limb, extremities or other external body parts.	IMDRF:F1902
C171094	CDRH Health Effect - Impact Code Terminology	C114146	Explanted Medical Device	A finding referring to a medical device that has been removed from the body, usually during a surgical procedure.	Device Explantation	4627	Patient required a corrective invasive procedure to remove a device, or parts/fragments of a device.	IMDRF:F1903
C171094	CDRH Health Effect - Impact Code Terminology	C171964	Device Repositioning	Patient required a corrective invasive procedure in which a device was repositioned.	Device Repositioning	4628	Patient required a corrective invasive procedure in which a device was repositioned. This includes implantable, surgically invasive (penetration through the surface of the body) or invasive (penetration though a natural body orifice or permanent artificial opening, e.g. stoma) devices.	IMDRF:F1904
C171094	CDRH Health Effect - Impact Code Terminology	C171965	Device Revision or Replacement	Patient required a corrective invasive procedure in which a device was replaced/revised.	Device Revision or Replacement	4629	Patient required a corrective invasive procedure in which a device was replaced/revised. This includes implantable, surgically invasive (penetration through the surface of the body) or invasive (penetration though a natural body orifice or permanent artificial opening, e.g. stoma) devices.	IMDRF:F1905
C171094	CDRH Health Effect - Impact Code Terminology	C172009	Modified Surgical Procedure	A change of surgical procedure from the original plan.	Modified Surgical Procedure	4630	A change of surgical procedures from the original plan.	IMDRF:F1906
C171094	CDRH Health Effect - Impact Code Terminology	C172010	More Complex Surgery	Surgery that is more complicated, more comprehensive or more extensive than planned.	More Complex Surgery	4631	Surgery that is more complicated, more comprehensive or more extensive than planned.	IMDRF:F1907
C171094	CDRH Health Effect - Impact Code Terminology	C50823	Prolonged Surgery	Surgery that is lengthy or that takes longer than anticipated.	Prolonged surgery	4632	Surgery that takes longer than anticipated.	IMDRF:F1908
C171094	CDRH Health Effect - Impact Code Terminology	C50422	Surgical Procedure Delayed	Surgical procedure unable to be completed when originally scheduled and put off until some time in the future.	Surgical Procedure Delayed	4633	Surgical procedure unable to be completed when originally scheduled and put off until some time in the future.	IMDRF:F1909
C171094	CDRH Health Effect - Impact Code Terminology	C172032	Serious Public Health Threat	Any event type, which results in imminent risk of death, serious injury, or serious illness to more than one individual, that requires prompt remedial action.	Serious Public Health Threat	4634	Any event type, which results in imminent risk of death, serious injury, or serious illness to more than one individual, that requires prompt remedial action.	IMDRF:F20
C171094	CDRH Health Effect - Impact Code Terminology	C172044	Unexpected Deterioration	Unexpected clinical deterioration of patient.	Unexpected Deterioration	4635	Unexpected clinical deterioration of patient.	IMDRF:F21
C171094	CDRH Health Effect - Impact Code Terminology	C172045	Unexpected Diagnostic Intervention Required	A necessary but unplanned diagnostic intervention.	Unexpected Diagnostic Intervention	4636	Diagnostic intervention needed to be completed that was not originally planned.	IMDRF:F22
C171094	CDRH Health Effect - Impact Code Terminology	C15189	Biopsy	The removal of tissue specimens or fluid from the living body for microscopic examination, performed to establish a diagnosis.	Biopsy	4637	Patient required removal of tissue or fluid specimen to establish a diagnosis.	IMDRF:F2201
C171094	CDRH Health Effect - Impact Code Terminology	C16546	Endoscopic Procedure	A diagnostic or therapeutic procedure in which an endoscope is inserted in a tubular organ to examine the structural architecture and/or remove abnormal tissues.	Endoscopic Procedure	4638	Patient required additional or unexpected endoscopic procedure.	IMDRF:F2202
C171094	CDRH Health Effect - Impact Code Terminology	C172046	Unexpected Imaging Required	A necessary but unplanned imaging procedure.	Imaging Required	4639	Requirement for imaging that was not originally planned.	IMDRF:F2203
C171094	CDRH Health Effect - Impact Code Terminology	C172047	Unexpected IVD Testing Required	Patient required additional or unexpected in vitro diagnostic (IVD) testing.	IVD Testing	4640	Patient required additional or unexpected IVD testing.	IMDRF:F2204
C171094	CDRH Health Effect - Impact Code Terminology	C172048	Unexpected Medical Intervention Required	Patient required an unforeseen medical intervention.	Unexpected Medical Intervention	4641	Patient required an unforeseen medical intervention, excluding surgery, which was not on the original treatment plan.	IMDRF:F23
C171094	CDRH Health Effect - Impact Code Terminology	C171939	Additional Device Required	Use of an additional or alternative device required to achieve optimal outcome.	Additional Device Required	4642	Use of an additional or alternative device require to achieve optimal outcome.	IMDRF:F2301
C171094	CDRH Health Effect - Impact Code Terminology	C15192	Blood Transfusion	The injection of whole blood or a blood component directly into the bloodstream.	Blood Transfusion	4643	Patient required an infusion of whole blood or a blood component directly into the bloodstream.	IMDRF:F2302
C171094	CDRH Health Effect - Impact Code Terminology	C171940	Additional Medication Required	Patient required additional medication or additional dose of existing medication.	Medication Required	4644	Patient required additional medication or additional dose of existing medication.	IMDRF:F2303
C171094	CDRH Health Effect - Impact Code Terminology	C95560	Prophylactic	Any intervention to prevent disease or infection.	Prophylactic Treatment	4645	A medication or course of action used to prevent a possible disease or condition from occurring.	IMDRF:F2304
C171094	CDRH Health Effect - Impact Code Terminology	C15313	Radiation Therapy	Treatment of a disease by means of exposure of the target or the whole body to radiation. Radiation therapy is often used as part of curative therapy and occasionally as a component of palliative treatment for cancer. Other uses include total body irradiation prior to transplantation.	Radiation Therapy	4646	Patient required additional radiation therapy.	IMDRF:F2305
C171094	CDRH Health Effect - Impact Code Terminology	C50822	Resuscitation	The measures applied for the restoration a person to life and/or consciousness. The act of resuscitation includes such components as artificial respiration and cardiac massage.	Resuscitation	4647	Patient required resuscitation.	IMDRF:F2306
C171094	CDRH Health Effect - Impact Code Terminology	C172138	Insufficient Information to Classify Health Impact	Not enough information available to classify the health impact.	Insufficient Information	4648	There is not yet enough information available to classify the health impact.	IMDRF:F24
C171094	CDRH Health Effect - Impact Code Terminology	C172042	Unanticipated Adverse Device Effect	Complication occurring in the patient that had not previously been identified or expected for this device.	Unanticipated Adverse Device Effect	4649	Complication occurring in the patient that had not previously been identified or expected for this device.	IMDRF:F25
C171094	CDRH Health Effect - Impact Code Terminology	C50675	Adverse Event with No Consequence or Impact	No apparent harm occurred in relation to the adverse event.	No Health Consequences or Impact	2199	No apparent harm occurred in relation to the adverse event.	IMDRF:F26
C171094	CDRH Health Effect - Impact Code Terminology	C50912	Adverse Event without Patient Involvement	No patient involvement when the adverse event occurred.	No Patient Involvement	2645	No patient involvement when the adverse event occurred (for example happened during set-up or cleaning).	IMDRF:F27
C171094	CDRH Health Effect - Impact Code Terminology	C171944	Appropriate Health Impact Term/Code Not Available	There is no appropriate Health Impact term or code.	Appropriate Term/Code Not Available	4650	The Health Impact is not adequately described by any other term. Note: this code must not be used unless there is no other feasible code. The preferred term should be documented when submitting an adverse event report. This information will be used to determine if a new term should be added to the code table.	IMDRF:F28
C54577	CDRH Component Code Terminology	C50372	Absorber Device	A device or material designed to take in or attenuate a force or substance.	Absorber	3028	A component or material designed to take in or attenuate a substance.	IMDRF:G01001
C54577	CDRH Component Code Terminology	C50345	Cautery Device	A device designed to coagulate and seal blood vessels or to destroy tissue with heat or electric current.	Cautery Tip	3039	A component designed to coagulate and seal blood vessels or to destroy tissue with heat or electric current.	IMDRF:G01002
C54577	CDRH Component Code Terminology	C76185	Device Ingredient or Reagent	A consumable material that is added to a device and is used to make a finished product or becomes part of a finished product.	Device Ingredient or Reagent	3050	A consumable material that is added to a device and is used to make a finished product or becomes part of a finished product.	IMDRF:G01003
C54577	CDRH Component Code Terminology	C49967	Gas Scavenging Device	A device designed to remove certain gases from a gas stream or environment.	Gas Scavenging	461	A component designed to remove certain gases from a gas stream or environment.	IMDRF:G01004
C54577	CDRH Component Code Terminology	C63845	Monomer	A chemical subunit that can undergo polymerization by bonding to other subunits.	Monomer Liquid	4702	The liquid that reacts with the polymer powder to form adhesive, resin, or cement.	IMDRF:G01005
C54577	CDRH Component Code Terminology	C50322	Test Strip Device	A piece of chemically treated medium designed to react in the presence of specific amounts of a trigger substance.	Test Strip	3121	A piece of chemically treated medium designed to react in the presence of specific amounts of a trigger substance.	IMDRF:G01006
C54577	CDRH Component Code Terminology	C172021	Polymer Bone Powder	The powder that reacts with the monomer liquid to form bone cement.	Polymer Powder	4703	The powder that reacts with the monomer liquid to form adhesive, resin, or cement.	IMDRF:G01007
C54577	CDRH Component Code Terminology	C49828	Antenna Device	A device designed to transmit or receive electromagnetic signals.	Antenna	595	A component designed to transmit or receive electromagnetic signals.	IMDRF:G02001
C54577	CDRH Component Code Terminology	C49839	Battery Device	A device designed to produce an electric current through chemical reaction.	Battery	420	A component designed to produce an electric current through chemical reaction.	IMDRF:G02002
C54577	CDRH Component Code Terminology	C50346	Battery Charger Device	A device designed to restore the capacity of a battery.	Battery Charger	3032	A device designed to restore the capacity of a battery.	IMDRF:G02003
C54577	CDRH Component Code Terminology	C172135	Electrical Cable	An electrical wire designed to carry signals or power over a distance	Cable, Electrical	423	A long, thin, multistranded electrical wire designed to carry signals or power over a distance.	IMDRF:G02004
C54577	CDRH Component Code Terminology	C171947	Cable Grip Device	Component used for tensioning, pulling or stringing of wires and cables.	Cable Grip	4705	Component used for tensioning, pulling or stringing of wires and cables.	IMDRF:G0200401
C54577	CDRH Component Code Terminology	C171948	Cable Sleeve Device	Component used to protect cables and wires from abrasion, moisture and the elements.	Cable Sleeve	4706	Component used to protect cables and wires from abrasion, moisture and the elements.	IMDRF:G0200402
C54577	CDRH Component Code Terminology	C49871	Circuit Board Device	A non-conducting board to which electronic components are attached.	Circuit Board	427	A non-conducting board with conductive tracks and electronic components forming a circuit.	IMDRF:G02005
C54577	CDRH Component Code Terminology	C50347	Circuit Breaker Device	A device designed to open an electrical circuit when it becomes overloaded.	Circuit Breaker	3040	A component designed to open an electrical circuit when it becomes overloaded.	IMDRF:G02006
C54577	CDRH Component Code Terminology	C61402	Computer Hardware Device	The physical components from which a computer is constructed (electronic circuits and input/output devices).	Computer Hardware	3041	The physical components from which a computer is constructed (electronic circuits and input/output devices).	IMDRF:G02007
C54577	CDRH Component Code Terminology	C172146	Computer Processor	Component that carries out the instructions of a computer program by performing the basic arithmetic, logic, controlling, and input/output operations specified by the instructions.	Computer Processor	4757	Component that carries out the instructions of a computer program by performing the basic arithmetic, logic, controlling, and input/output operations specified by the instructions.	IMDRF:G0200701
C54577	CDRH Component Code Terminology	C50047	Memory Device	Any device that can hold data in machine-readable format.	Memory/Storage	877	Any component that can hold data in machine-readable format.	IMDRF:G0200702
C54577	CDRH Component Code Terminology	C50081	Network Device	A collection of two or more computers and associated devices that are linked together with communications equipment.	Network Interface	890	Point of interconnection between a computer and other computer that are linked each other.	IMDRF:G0200703
C54577	CDRH Component Code Terminology	C17146	Computer Program	A set of coded instructions, which a computer follows in processing data, performing an operation, or solving a logical problem, upon execution of the program.	Computer Software	4707	A collection of data or computer instructions that tell the computer how to work.	IMDRF:G02008
C54577	CDRH Component Code Terminology	C49931	Driver Device	A computer interface designed to control the interaction between a CPU and a peripheral device.	Driver	4708	A computer interface designed to control the interaction between a CPU and a peripheral device.	IMDRF:G0200801
C54577	CDRH Component Code Terminology	C75301	Application Program Interface	A set of protocols designed to provide communication between a software application and a computer operating system or between applications.	Software Interface	4709	Languages, codes and messages that programs use to communicate with each other and to the hardware.	IMDRF:G0200802
C54577	CDRH Component Code Terminology	C54008	User Interface Device	A computer program that controls the interaction between a user and a system.	User Interface	444	A computer program that controls the interaction between a user and a system.	IMDRF:G0200803
C54577	CDRH Component Code Terminology	C50319	Cooling Module Device	A device designed to regulate and lower the temperature of a heat generating device or system.	Cooling Module	3044	A component designed to lower the temperature of a device or system.	IMDRF:G02009
C54577	CDRH Component Code Terminology	C50123	Programmer Device	A device designed to write instructions to a memory device.	Device Programmer	920	A piece of hardware for transferring data onto programmable integrated circuits.	IMDRF:G02010
C54577	CDRH Component Code Terminology	C50132	Reader Device	A device designed to capture data encoded on an object and convert it to a signal that can be input into a computer.	Device Reader	929	A piece of hardware used to read the memory and the properties of a device.	IMDRF:G02011
C54577	CDRH Component Code Terminology	C49924	Discrete Device	A device that exists separate from other devices; can refer to electronic components that are not part of an integrated circuit.	Discrete Electrical Component	448	An electrical component which is just one circuit, either passive or active, that is not an integrated circuit.	IMDRF:G02012
C54577	CDRH Component Code Terminology	C49862	Capacitor Device	An electrical device designed to store an electric charge.	Capacitor	555	An electrical component designed to store an electric charge.	IMDRF:G0201201
C54577	CDRH Component Code Terminology	C49966	Fuse Device	An electrical device designed to stop the flow of current when an overload condition exists.	Fuse	822	An electrical component designed to stop the flow of current when an overload condition exists.	IMDRF:G0201202
C54577	CDRH Component Code Terminology	C50003	Inductor Device	A device designed to introduce electromotive force to a circuit, usually a coil surrounding a wire.	Inductor	845	A component designed to introduce electromotive force to a circuit, usually a coil surrounding a wire.	IMDRF:G0201203
C54577	CDRH Component Code Terminology	C50141	Resistor Device	An electronic device that opposes the flow of current.	Resistor	935	An electronic component that opposes the flow of current.	IMDRF:G0201204
C54577	CDRH Component Code Terminology	C50181	Solenoid Device	An electronic device consisting of a coil surrounding a movable iron core that is designed to act as a switch or relay.	Solenoid	512	An electronic component consisting of a coil surrounding a movable iron core that is designed to act as a switch or relay.	IMDRF:G0201205
C54577	CDRH Component Code Terminology	C50226	Transducer Device	An electrical device that converts one form of energy into another.	Transducer	522	An electrical component that converts one form of energy into another.	IMDRF:G0201206
C54577	CDRH Component Code Terminology	C172788	Semiconductor	A type of electronic component that makes use of the variable conductivity of certain materials.	Semiconductor	4763	A type of electronic component, including transistors and diodes, that make use of the variable conductivity of certain materials.	IMDRF:G0201207
C54577	CDRH Component Code Terminology	C49995	Integrated Circuit Chip Device	A microelectronic device that incorporates many interconnected transistors and components.	IC (Integrated Circuit) Chip	472	A microelectronic circuit that incorporates many interconnected transistors and other components.	IMDRF:G02013
C54577	CDRH Component Code Terminology	C49927	Device Display Device	A device designed to present information visually.	Display	416	A component designed to present information visually. In the case of Touchscreen, use G0204004.	IMDRF:G02014
C54577	CDRH Component Code Terminology	C50001	Indicator Device	A device designed to show an operating condition of a system or to attract attention.	Indicator	844	A component designed to show an operating condition of a system or to attract attention.	IMDRF:G0201401
C54577	CDRH Component Code Terminology	C50160	Screen Device	An electronic device designed as a display or a physical device designed to be a protective meshwork.	Screen	953	A panel or area on an electronic device where images and data are displayed.	IMDRF:G0201402
C54577	CDRH Component Code Terminology	C50027	Electrical Lead Device	A coated or uncoated wire used to connect two locations electronically.	Electrical Lead/Wire	452	A coated or uncoated wire used to connect two locations electronically. Not to be used for patient connection.	IMDRF:G02015
C54577	CDRH Component Code Terminology	C49936	Electrode Device	A conductor that is designed to make contact with part of a circuit or system.	Electrode	451	A small piece of metal or other conductive substance this is used to take an electric current to or from a source of power, a piece of equipment. Not to be used for patient connection.	IMDRF:G0201501
C54577	CDRH Component Code Terminology	C49973	Ground Strap Device	A wire cable or strap designed to carry current safely away from an electronic device.	Ground Strap/Wire	828	A wire cable or strap designed to carry current safely away from an electronic device under fault condition	IMDRF:G0201502
C54577	CDRH Component Code Terminology	C50272	Wiring Harness Device	A collection of grouped wires or cables designed to connect to a specific device.	Wiring Harness	544	A collection of grouped wires or cables designed to connect to a specific device.	IMDRF:G0201503
C54577	CDRH Component Code Terminology	C172141	Electrical Mixer	An electronic component designed to blend signals.	Electrical Mixer	4758	An electronic component designed to blend signals.	IMDRF:G02016
C54577	CDRH Component Code Terminology	C172143	Electrical Port	An electronic circuit that acts as a connection to another device or component.	Electrical Port	4759	An electronic circuit that acts as a connection to another device or component.	IMDRF:G02017
C54577	CDRH Component Code Terminology	C49937	Emitter Device	The electron source electrode in a transistor or any source in a system.	Emitter	799	The electron source electrode in a transistor or any source in a system.	IMDRF:G02018
C54577	CDRH Component Code Terminology	C49982	Headset Device	An accessory for a telephone that is worn on the head and designed to allow hands free conversation.	Headphone/Headset	4710	A component that covers the ear through which you can listen to without other people hearing. Some headphones come with a microphone which is used to communicate with other people or the device.	IMDRF:G02019
C54577	CDRH Component Code Terminology	C49986	Heater Device	A device designed to generate heat.	Heater	467	A piece of equipment used to raise the temperature of air, gas or water or an object.	IMDRF:G02020
C54577	CDRH Component Code Terminology	C49991	Hub Device	An electronic device designed as a central connection for other devices.	Hub	469	An electronic component designed as a central connection for other devices or components.	IMDRF:G02021
C54577	CDRH Component Code Terminology	C50010	Inverter Device	An electrical device that converts direct current to alternating current.	Inverter	850	An electrical component that converts direct current to alternating current.	IMDRF:G02022
C54577	CDRH Component Code Terminology	C50040	Magnet Device	A device that attracts iron and produces a magnetic field.	Magnet	482	A component that attracts iron and produces a magnetic field.	IMDRF:G02023
C54577	CDRH Component Code Terminology	C50088	Oscillator Device	An electronic device designed to produce a wave signal.	Oscillator	896	An electronic component designed to produce a wave signal.	IMDRF:G02024
C54577	CDRH Component Code Terminology	C50282	Lead Device	An insulated electrical conductor designed to connect to an electrical device.	Patient Lead	3079	An insulated electrical cable designed to connect to an electrical device to a patient.	IMDRF:G02025
C54577	CDRH Component Code Terminology	C50028	Lead Conductor Device	A bundle of leads designed to connect between a pacing device and implanted heart electrodes.	Lead Conductor	476	A cable designed to conduct electricity from the device to the lead.	IMDRF:G0202501
C54577	CDRH Component Code Terminology	C172140	Patient Electrode	An electrical conductor that is designed to make contact with a patient.	Patient Electrode	4760	An electrical conductor that is designed to make contact with a patient including defibrillator paddles.	IMDRF:G0202502
C54577	CDRH Component Code Terminology	C49892	Power Cord Device	A flexible cable designed to connect an electric device to a power source.	Power Cord	497	A flexible cable designed to connect an electrical device to a power outlet.	IMDRF:G02026
C54577	CDRH Component Code Terminology	C50115	Power Supply Device	Any electronic device designed to supply power to other devices.	Power Supply	498	Component designed to supply electrical power to devices.	IMDRF:G02027
C54577	CDRH Component Code Terminology	C50299	Transducer Pressure Probe Device	A probe device designed to convert a change in pressure into a varying electrical signal.	Pressure Transducer Probe	4711	A probe component designed to convert a change in pressure into a varying electrical signal.	IMDRF:G02028
C54577	CDRH Component Code Terminology	C50120	Printer Device	An electronic device that is designed to transfer text or images to paper or other substrate.	Printer	917	An electronic component that is designed to transfer text or images to paper or other substrate.	IMDRF:G02029
C54577	CDRH Component Code Terminology	C50133	Receiver Device	An electronic device designed to capture an incoming electromagnetic signal and convert it to an audible or visual signal.	Receiver	930	An electronic component designed to capture an incoming electromagnetic signal and convert it to an audible or visual signal.	IMDRF:G02030
C54577	CDRH Component Code Terminology	C50330	Receiver Stimulator Unit Device	As part of a cochlear implant, an implanted device designed to receive signal from the external device and then decode the signal and transmit it to the brain.	Receiver Stimulator Unit	3101	As part of a cochlear implant, an implanted component designed to receive signal from the external component and then decode the signal and transmit it to the brain.	IMDRF:G02031
C54577	CDRH Component Code Terminology	C50158	Scanner Device	An electronic device that generates a digital representation of an image for data input to a computer or a receiver designed to search for a signal within a specified frequency range.	Scanner	950	An electronic component that generates a digital representation of an image for data input to a computer; or a receiver designed to search for a signal within a specified frequency range.	IMDRF:G02032
C54577	CDRH Component Code Terminology	C50184	Speaker Device	A device designed to convert electrical signals to sounds that can be heard.	Speaker/Sounder	971	A component designed to convert electrical signals to sounds that can be heard.	IMDRF:G02033
C54577	CDRH Component Code Terminology	C50199	Switch Device	A mechanical or electronic device designed to break or change the connections in a circuit.	Switch/Relay	4712	A mechanical or electronic component designed to break or change the connections in a circuit (e.g. button).	IMDRF:G02034
C54577	CDRH Component Code Terminology	C50200	Power Switch Device	A switch designed to regulate the power to a device.	Power Switch	499	A switch designed to regulate the power to a device.	IMDRF:G0203401
C54577	CDRH Component Code Terminology	C50138	Relay Device	An electrical circuit designed to act as a switch for another circuit.	Relay	508	A electronic component designed to break or change the connections in a circuit.	IMDRF:G0203402
C54577	CDRH Component Code Terminology	C50211	Telemetry Equipment Device	Equipment designed to transmit and receive data from a remote source using telecommunications methods.	Telemetry	520	Component designed to transmit and receive data from a remote source using telecommunications methods.	IMDRF:G02035
C54577	CDRH Component Code Terminology	C50215	Temperature Compensator Device	A device designed to vary the temperature of one system in response to temperature changes in another system or the environment.	Temperature Compensator	996	A component designed to compensate the temperature of one system in response to temperature changes in another system or the environment.	IMDRF:G02036
C54577	CDRH Component Code Terminology	C50221	Thermostat Device	A device designed to regulate temperature by controlling the starting and stopping of a heating/cooling system.	Thermostat	3159	A component designed to regulate temperature by controlling the starting and stopping of a heating/cooling system.	IMDRF:G02037
C54577	CDRH Component Code Terminology	C50227	Transformer Device	A device that either steps up or steps down an alternating electrical current to an output that is suitable for another electrical device.	Transformer	523	A component that either steps up or steps down an alternating electrical current to an output that is suitable for another electrical device or component.	IMDRF:G02038
C54577	CDRH Component Code Terminology	C50231	Transmitter Device	A device to propagate electromagnetic waves.	Transmitter	3141	A component to propagate electromagnetic waves.	IMDRF:G02039
C54577	CDRH Component Code Terminology	C171959	Computer Input Device	A piece of computer hardware that enables the provision of data and control signals to an information processing system such as a computer.	User Input Device	4713	A component that uses a movable handle to create two-axis input to a computer.	IMDRF:G02040
C54577	CDRH Component Code Terminology	C50015	Joystick Device	A control device that uses a movable handle to create two-axis input for a computer device.	Joystick	855	A control component that uses a movable handle to create two-axis input to a computer.	IMDRF:G0204001
C54577	CDRH Component Code Terminology	C50018	Keyboard Device	A device consisting of mechanical keys that are pressed to create input to a computer.	Keyboard/Keypad	475	A component consisting of mechanical keys that are pressed to create input to a computer.	IMDRF:G0204002
C54577	CDRH Component Code Terminology	C50068	Microphone Device	A device designed to convert sound to an electrical signal.	Microphone	880	A component designed to convert sound to an electrical signal.	IMDRF:G0204003
C54577	CDRH Component Code Terminology	C172789	Touchscreen	A control component that operates an electronic device by pressing the display on the screen.	Touchscreen	4764	A control component that operates the device following pressing the display on the screen.	IMDRF:G0204004
C54577	CDRH Component Code Terminology	C49826	Analyzer Device	Any device designed to perform an analysis.	Analyzer	593	Any component designed to perform an analysis.	IMDRF:G03001
C54577	CDRH Component Code Terminology	C50094	Oxygen Analyzer Device	A device designed to measure the concentration of oxygen in a gas mixture.	Oxygen Analyzer	491	A component designed to measure the concentration of oxygen in a gas mixture.	IMDRF:G0300101
C54577	CDRH Component Code Terminology	C171942	Aperture Device	An instrument designed to measure the size of an opening or one used to increase the diameter of an opening.	Aperture	4715	An instrument designed to measure the size of an opening or one used to increase the diameter of an opening	IMDRF:G03002
C54577	CDRH Component Code Terminology	C49857	Calibrator Device	An instrument designed to measure the size of an opening or one used to increase the diameter of an opening; can also refer to a standard or reference material used to set the operating parameters of an instrument.	Calibrator	747	A standard or reference material used to set the operating parameters of an instrument.	IMDRF:G03003
C54577	CDRH Component Code Terminology	C49874	Clock Device	A device designed to indicate the time of day or to measure the time duration of an event or action.	Clock	759	A component designed to indicate the time of day.	IMDRF:G03004
C54577	CDRH Component Code Terminology	C49894	Counter Device	A device designed to keep track of the number of times something happens.	Counter	770	A component designed to keep track of the number of times something happens.	IMDRF:G03005
C54577	CDRH Component Code Terminology	C172790	Cuvette	A clear container designed to interface with an optical sensor in order to obtain an optical measurement of a contained substance.	Cuvette	4765	A clear container designed to interface with an optical sensor in order to obtain an optical measurement of a contained substance.	IMDRF:G03006
C54577	CDRH Component Code Terminology	C50052	Gauge or Meter Device	A device designed to give a visual indication of the condition of a system.	Gauges/Meters	462	A component designed to give a visual indication of the condition of a system.	IMDRF:G03007
C54577	CDRH Component Code Terminology	C50054	Flowmeter Device	A device designed to measure the flow rate of a fluid.	Flowmeter	458	A component designed to measure the flow rate of a fluid.	IMDRF:G0300701
C54577	CDRH Component Code Terminology	C172005	Manometer Device	A component designed to measure pressure.	Manometer	4716	A component designed to measure pressure.	IMDRF:G0300702
C54577	CDRH Component Code Terminology	C50059	Thermometer Device	A device designed to measure temperature.	Thermometer	3158	A component designed to measure temperature.	IMDRF:G0300703
C54577	CDRH Component Code Terminology	C177671	Marker	A visual indicator of position, place or route.	Marker	4717	A visual indicator of position, place or route, including radiopaque markers.	IMDRF:G03008
C54577	CDRH Component Code Terminology	C50296	Pipette Device	A measuring device, traditionally including a graduated tube, designed for the accurate transfer of liquid volumes.	Pipette	3097	A measuring component, traditionally including a graduated tube, designed for the accurate transfer of liquid volumes.	IMDRF:G03009
C54577	CDRH Component Code Terminology	C50109	Pointer Device	An indicator device designed to show a position on a scale.	Pointer	910	An indicator component designed to show a position on a scale.	IMDRF:G03010
C54577	CDRH Component Code Terminology	C50156	Scale Device	A device designed for weighing or an indicator device with a graduated sequence of divisions.	Scale	949	A component designed for weighing or an indicator component with a graduated sequence of divisions.	IMDRF:G03011
C54577	CDRH Component Code Terminology	C50166	Sensor Device	A device designed to respond to a stimulus by generating a signal that can be measured or interpreted.	Sensor	510	A component designed to respond to a stimulus by generating a signal that can be measured or interpreted.	IMDRF:G03012
C54577	CDRH Component Code Terminology	C50354	Bubble Detector Device	A device designed to signal the presence of bubbles in a system.	Bubble Sensor	3035	A component designed to signal the presence of bubbles in a system.	IMDRF:G0301201
C54577	CDRH Component Code Terminology	C50168	Oxygen Sensor Device	A sensor designed to respond to the presence or level of oxygen in a space or environment.	O2 Sensor	892	A sensor designed to respond to the presence or level of oxygen in a space or environment.	IMDRF:G0301202
C54577	CDRH Component Code Terminology	C49917	Photodetector Device	A device designed to detect light.	Photodetector	902	A component designed to detect light.	IMDRF:G0301203
C54577	CDRH Component Code Terminology	C50167	Pressure Sensor Device	A sensor designed to respond to the level of pressure in a space or pressing on a surface.	Pressure Sensor	500	A sensor designed to respond to the level of pressure in a space or pressing on a surface.	IMDRF:G0301204
C54577	CDRH Component Code Terminology	C172145	Sensor Probe	A component designed to reach into a location for sensing. Should be used when the problem involves the probe, not the sensor.	Sensor Probe	4718	A component designed to reach into a location for sensing. Should be used when the problem involves the probe, not the sensor.	IMDRF:G0301205
C54577	CDRH Component Code Terminology	C50304	Temperature Sensor Device	A sensor designed to respond to the temperature of a space, surface, or environment.	Temperature Sensor	3120	A sensor designed to respond to the temperature of a space, surface, or environment.	IMDRF:G0301206
C54577	CDRH Component Code Terminology	C50223	Timer Device	A device designed to measure a time interval.	Timer	3136	A component designed to measure a time interval.	IMDRF:G03013
C54577	CDRH Component Code Terminology	C172144	Medical Port Access Device	A component designed for the introduction or removal of medical equipment or any substance.	Access Port	4761	A component designed for the introduction or removal of medical equipment or any substance.	IMDRF:G04001
C54577	CDRH Component Code Terminology	C49807	Actuator Device	A device designed to automate an action.	Actuator	402	A component which moves or controls a mechanism or system.	IMDRF:G04002
C54577	CDRH Component Code Terminology	C49808	Adapter Device	A device designed to make different pieces of apparatus compatible.	Adapter (Adaptor)	431	A component designed to make different pieces of apparatus compatible.	IMDRF:G04003
C54577	CDRH Component Code Terminology	C50339	Air Eliminator Device	A device designed to remove air from a space or fluid.	Air Eliminator	3029	A component designed to remove air from a space or fluid.	IMDRF:G04004
C54577	CDRH Component Code Terminology	C142436	Clinical Study Anchor	A planned activity within a clinical study that marks a transition between epochs or elements within the clinical study.	Anchor	4720	A component designed to fix the device or a portion of the device in place.	IMDRF:G04005
C54577	CDRH Component Code Terminology	C50341	Applicator Device	A device designed to transfer a substance to a surface.	Applicator	3030	A component designed to transfer a substance to a surface.	IMDRF:G04006
C54577	CDRH Component Code Terminology	C50317	Automatic Injection System Device	A system designed to pump a gas or liquid into a space or environment without outside intervention.	Automatic Injection System	3031	A system designed to pump a gas or liquid into a space or environment without outside intervention.	IMDRF:G04007
C54577	CDRH Component Code Terminology	C49834	Bag Device	A flexible container, often with a single opening.	Bag	553	A flexible container, often with a single opening.	IMDRF:G04008
C54577	CDRH Component Code Terminology	C49835	Ball Device	Any device that is spherical in shape.	Ball	418	Any component that is spherical in shape.	IMDRF:G04009
C54577	CDRH Component Code Terminology	C49837	Balloon Device	Any of various types of bags designed to be distended.	Balloon	419	A sac designed to be inflated and deflated.	IMDRF:G04010
C54577	CDRH Component Code Terminology	C49842	Bearing Device	A point of contact between moving parts designed for support or to reduce friction.	Bearings	734	A point of contact between moving parts designed for support or to reduce friction.	IMDRF:G04011
C54577	CDRH Component Code Terminology	C172792	Bellows	A component that expands and contracts to draw in air through a valve or orifice and expels it through a tube.	Bellows	4766	A component that expands and contracts to draw in air through a valve or orifice and expels it through a tube.	IMDRF:G04012
C54577	CDRH Component Code Terminology	C49844	Belt Device	A device consisting of a narrow loop of material moving over shafts or pulleys.	Belt	737	A component consisting of a narrow band of material moving over shafts or pulleys.	IMDRF:G04013
C54577	CDRH Component Code Terminology	C43169	Bottle	A vessel with a narrow neck designed to accept a specific closure.	Bottle	4726	A rigid or semi-rigid container used to store liquid.	IMDRF:G04014
C54577	CDRH Component Code Terminology	C49850	Breathing Circuit Device	In an anesthesia machine, the pathway by which a gaseous anesthetic agent and oxygen are delivered to the patient and carbon dioxide is removed. The circuit can be open or closed.	Breathing Circuit	422	In an anesthesia machine, the pathway by which a gaseous anesthetic agent and oxygen are delivered to the patient and carbon dioxide is removed. The circuit can be open or closed.	IMDRF:G04015
C54577	CDRH Component Code Terminology	C49851	Brush Device	Device consisting of hairs or bristles set into a handle or holder, especially one that conducts current between the rotating and stationary parts of a generator or motor.	Brush	743	A component consisting of hairs or bristles set into a handle or holder.	IMDRF:G04016
C54577	CDRH Component Code Terminology	C49853	Bushing Device	A cylindrical metal sleeve designed to reduce the friction of a rotating shaft.	Bushing	746	A cylindrical metal sleeve designed to reduce the friction of a rotating shaft.	IMDRF:G04017
C54577	CDRH Component Code Terminology	C49855	Cable Device	A long, thin, multistranded rope or rope-like object; a multistranded conductor designed to carry signals over a distance.	Cable, Mechanical/Structural	4727	A long, thin, multistranded rope or metallic wire to hold the subject.	IMDRF:G04018
C54577	CDRH Component Code Terminology	C50343	Cannula Device	A small flexible tube inserted into a body cavity for draining off fluid or introducing medication.	Cannula	3036	A rigid or semi-rigid tube inserted into the body.	IMDRF:G04019
C54577	CDRH Component Code Terminology	C171949	Cannula Hub	A small metal or plastic component that connects to the end of the intravenous cannula that is intended to connect to other devices, usually for medication or fluid delivery.	Cannula Hub	4728	A metal or plastic component that connects to the cannula.	IMDRF:G0401901
C54577	CDRH Component Code Terminology	C49861	Cap Device	A top (as for a bottle).	Cap	424	A component designed to close an opening of a container or device.	IMDRF:G04020
C54577	CDRH Component Code Terminology	C49863	Carrier Device	A device designed to facilitate the support, movement, or transport of another device or object.	Carrier	752	A component designed to facilitate the support, movement, or transport of another device or object.	IMDRF:G04021
C54577	CDRH Component Code Terminology	C49866	Caster Device	A pivoting roller or wheel designed to attach to an object to make it movable.	Caster	753	A pivoting roller or wheel designed to attach to an object to make it movable.	IMDRF:G04022
C54577	CDRH Component Code Terminology	C50344	Catheter Device	A flexible tube designed to transfer fluids into or out of the body.	Catheter	3038	A flexible tube inserted into the body designed to permit injection or withdrawal of fluids or to keep passage open.	IMDRF:G04023
C54577	CDRH Component Code Terminology	C171952	Catheter Hub	A small metal or plastic component that connects to the end of the catheter.	Catheter Hub	4729	A small metal or plastic component that connects to the catheter.	IMDRF:G0402301
C54577	CDRH Component Code Terminology	C49867	Cell Device	A device that is designed as a removable and replaceable part of another device.	Cell	754	A component that is designed as a container to collect and/or transfer materials, reagents or specimens.	IMDRF:G04024
C54577	CDRH Component Code Terminology	C41207	Chain	A series of objects linked, connected, or associated together in linear fashion (e.g., the assemblage of atoms, radicals and chemical groups in a chemical compound, or an assemblage of individual microorganisms).	Chain	4730	Assembly of interconnected links, typically made of metal used for connecting other components.	IMDRF:G04025
C54577	CDRH Component Code Terminology	C171955	Chamber	A component designed as a reservoir/storage.	Chamber	4731	A component designed as a reservoir/storage.	IMDRF:G04026
C54577	CDRH Component Code Terminology	C49869	Chassis Device	A supporting frame designed to hold other components or devices such as the chassis of a car or the internal frame of an electronic device.	Chassis/Frame	755	A supporting frame designed to hold other components or devices such as the internal frame of an electronic device.	IMDRF:G04027
C54577	CDRH Component Code Terminology	C172793	Clutch	A component that engages and disengages power transmission.	Clutch	4767	A component that engages and disengages power transmission.	IMDRF:G04028
C54577	CDRH Component Code Terminology	C172794	Coating Material	A layer of material covering the surface of a device.	Coating Material	4768	A layer of material covering the surface of a device.	IMDRF:G04029
C54577	CDRH Component Code Terminology	C49877	Coil Device	A structure consisting of something wound in a continuous series of loops.	Coil	761	A structure consisting of something wrapped in a continuous series of loops.	IMDRF:G04030
C54577	CDRH Component Code Terminology	C49880	Helifix Coil Device	A coil designed to allow a Helifix pacing electrode to be placed in the endocardium.	Helifix Coil	567	A coil designed to allow a Helifix pacing electrode to be placed in the endocardium.	IMDRF:G0403001
C54577	CDRH Component Code Terminology	C49881	Collimator Device	A diaphragm or system of diaphragms made of an absorbing material, designed to define and restrict the dimensions and direction of a beam of radiation.	Collimator	762	A diaphragm or system of diaphragms made of an absorbing material, designed to define and restrict the dimensions and direction of a beam of radiation.	IMDRF:G04031
C54577	CDRH Component Code Terminology	C49883	Concentrator Device	A device designed to increase the weight per unit volume of a substance, or in communications, a device that combines data streams in a way that they can be separated after transmission.	Concentrator	558	A component designed to increase the weight per unit volume of a substance.	IMDRF:G04032
C54577	CDRH Component Code Terminology	C70849	Cone	A shape whose base is a circle and whose sides taper up to a point.	Cone	4732	A three-dimensional part that tapers smoothly from a flat circular shape at one end to a point at the other end.	IMDRF:G04033
C54577	CDRH Component Code Terminology	C49895	Coupler Device	Any device designed to connect other objects.	Connector/Coupler	4733	A component designed to serve as a link between parts allowing easy disconnection and reconnection when necessary.	IMDRF:G04034
C54577	CDRH Component Code Terminology	C50295	Connector Pin Device	A projecting part of a device that allows it to be secured through an opening.	Connector Pin	3043	A projecting part of a device that allows it to be secured through an opening.	IMDRF:G0403401
C54577	CDRH Component Code Terminology	C49887	Controller Device	A device designed to control or regulate the operation of another device.	Controller	765	A component designed to control or regulate the operation of another device.	IMDRF:G04035
C54577	CDRH Component Code Terminology	C50129	Compressor Air Pump Device	A pump designed to facilitate the movement or compression of air.	Compressor	557	A component that increases the pressure of air or gas.	IMDRF:G04036
C54577	CDRH Component Code Terminology	C49896	Cover Device	An object designed to conceal, enclose, cap, or protect something.	Cover	772	An object designed to conceal, enclose, or protect something.	IMDRF:G04037
C54577	CDRH Component Code Terminology	C49900	Cuff Device	A bandlike device or structure that encircles a body part or another device.	Cuff	562	A bandlike structure that encircles a body part or another component or device.	IMDRF:G04038
C54577	CDRH Component Code Terminology	C49901	Cup Device	Any part of a device that resembles a bowl-shaped container.	Cup	774	Part or design of a device with a concave hemispherical shape.	IMDRF:G04039
C54577	CDRH Component Code Terminology	C49904	Cusp Device	A device consisting of flexible biocompatible membranes, implantable in the cardio-vascular system, designed to prevent retrograde flow of blood but not impede a forward flow.	Cusp/Leaflet	439	A thin blade-like component, typically used as part of a one-way valve.	IMDRF:G04040
C54577	CDRH Component Code Terminology	C49905	Cutter Device	A device designed to slice or sever a material.	Cutter/Blade	777	A component designed for slicing or cutting.	IMDRF:G04041
C54577	CDRH Component Code Terminology	C49906	Cylinder Device	Any part of a device that resembles an enclosed tube; a cylindrical container for the storage of gases and fluids.	Cylinder	440	A three-dimensional part with flat circular ends and long straight sides.	IMDRF:G04042
C54577	CDRH Component Code Terminology	C172795	Device Collapser	A component designed to fold or collapse something.	Device Collapser	4769	A component designed to fold or collapse something.	IMDRF:G04043
C54577	CDRH Component Code Terminology	C49918	Device Deployer Device	A device designed to install something or distribute something in a systematic way.	Device Deployer	788	A component designed to install something or distribute something in a systematic way.	IMDRF:G04044
C54577	CDRH Component Code Terminology	C49920	Device Diaphragm Device	A device consisting of a flexible sheet or partition.	Diaphragm	445	A component consisting of a flexible sheet or partition.	IMDRF:G04045
C54577	CDRH Component Code Terminology	C49929	Dome Device	A device component designed with a hemispherical shape.	Dome	793	Part or design of a device with a convex hemispherical shape.	IMDRF:G04046
C54577	CDRH Component Code Terminology	C171971	Ejector Device	A mechanism that pushes a device or component out.	Ejector	4734	A mechanism that pushes a device or component out.	IMDRF:G04047
C54577	CDRH Component Code Terminology	C171973	Equipment Pole Device	A structural component designed to hang medical equipment.	Equipment Pole	4735	A structural component designed to hang medical equipment.	IMDRF:G04048
C54577	CDRH Component Code Terminology	C49944	Extender Device	A device designed to lengthen a structure.	Extender	806	A component designed to lengthen a structure.	IMDRF:G04049
C54577	CDRH Component Code Terminology	C172796	Fabric	Material formed by weaving, knitting, felting, or pressing fibers together.	Fabric	4770	Cloth produced from textile fibers.	IMDRF:G04050
C54577	CDRH Component Code Terminology	C49947	Fan Device	A device designed to create an air current through the rotation of a planar surface.	Fan/Blower	4736	A component designed to create an air current through the rotation of a planar surface.	IMDRF:G04051
C54577	CDRH Component Code Terminology	C49948	Fastener Device	A device designed to hold something in place.	Fastener	810	A component designed to hold items in place.	IMDRF:G04052
C54577	CDRH Component Code Terminology	C89528	Adhesive Device	Any substance that affixes 2 or more parts or tissues together.	Adhesive	3194	Any substance that affixes 2 or more surfaces together. This may be supplied separately, or attached to another item such as tape.	IMDRF:G0405201
C54577	CDRH Component Code Terminology	C49847	Bolt Device	A screw designed to thread into a nut to form a fastener.	Bolt	741	A cylindrical connector element which may have a thread/nut connection to form a fastener.	IMDRF:G0405202
C54577	CDRH Component Code Terminology	C49872	Clamp Device	A device designed to hold things firmly together.	Clamp	757	A component designed to mechanically hold items firmly together.	IMDRF:G0405203
C54577	CDRH Component Code Terminology	C49873	Clip Device	A small device designed to hold and attach items together.	Clip	758	A small component designed to hold and attach items together.	IMDRF:G0405204
C54577	CDRH Component Code Terminology	C171978	Fixation Wire	A metal strand designed to affix the position of two or more structures.	Fixation Wire	4737	A metal strand designed for structural or other purpose.	IMDRF:G0405205
C54577	CDRH Component Code Terminology	C54022	Latch Device	A fastening device for a swinging part usually consisting of a bar that is retained in a slot.	Latch	1030	A fastening component for a mobile part usually consisting of a bar that is retained in a slot.	IMDRF:G0405206
C54577	CDRH Component Code Terminology	C172012	Nail Device	A pin-shaped fastener with a sharp point at one end and usually flat on the other end.	Nail	4738	A pin-shaped fastener with a sharp point at one end and usually flat on the other end.	IMDRF:G0405207
C54577	CDRH Component Code Terminology	C50084	Nut Device	A threaded fastener designed to engage a bolt.	Nut	891	A threaded fastener designed to engage a bolt.	IMDRF:G0405208
C54577	CDRH Component Code Terminology	C50101	Pin Device	A small, slender object designed to secure another object.	Pin	906	A small, slender separate component which is designed to secure another object.	IMDRF:G0405209
C54577	CDRH Component Code Terminology	C50124	Prong Device	Any pointed projection on a device, usually one designed to attach a device to something else.	Prong	504	A projecting pointed part of a device, usually one designed to attach a device to something else.	IMDRF:G0405210
C54577	CDRH Component Code Terminology	C50144	Retainer Device	A physical device designed to hold something in place.	Retainer	938	A physical component designed to hold items in place.	IMDRF:G0405211
C54577	CDRH Component Code Terminology	C50151	Rivet Device	A fastening device resembling a heavy pin, having a head on one end and designed to have the other end flattened after passing through the pieces to be connected.	Rivet	944	A fastening component resembling a heavy pin, having a head on one end and designed to have the other end flattened after passing through the parts to be connected.	IMDRF:G0405212
C54577	CDRH Component Code Terminology	C50161	Screw Device	A fastener device with a tapered threaded shaft and a head designed to engage a drive device.	Screw	568	A fastening component with a tapered threaded shaft and a head designed to engage with a driving tool.	IMDRF:G0405213
C54577	CDRH Component Code Terminology	C50307	Staple Device	A fastening device consisting of a bent wire designed to pierce and hold.	Staple	3110	A fastening component consisting of a bent wire designed to pierce and hold two or more surfaces together.	IMDRF:G0405214
C54577	CDRH Component Code Terminology	C50365	Suture Device	A natural (e.g., catgut, silk, or linen) or synthetic, or other (e.g., thin metal wire) monofilament or multifilament material used surgically to close a surgical or accidental wound and to secure apposition of the edges and join tissues.	Suture Thread	3114	A monofilament or multifilament material used surgically to close a wound, join tissues, or fasten components of a device (e.g. fabric to wire stent frame).	IMDRF:G0405215
C54577	CDRH Component Code Terminology	C50209	Tape Device	A long, thin, flat, flexible material often used for measuring, binding or fastening, or as a recording medium.	Tape for Fixation	990	A long, thin, flat, flexible material often used for binding or fastening.	IMDRF:G0405216
C54577	CDRH Component Code Terminology	C49952	Fiber Device	Any device made from a long, slender material.	Fiber	814	Any component made from a long, slender material.	IMDRF:G04053
C54577	CDRH Component Code Terminology	C49956	Filter Device	A device designed to remove something from whatever passes through it.	Filter	816	A component designed to remove something from whatever passes through it.	IMDRF:G04054
C54577	CDRH Component Code Terminology	C49959	Flange Device	A protruding edge designed to strengthen or stabilize a device or facilitate its attachment to a surface.	Flange	457	A protruding edge designed to strengthen or stabilize a device or facilitate its attachment to a surface.	IMDRF:G04055
C54577	CDRH Component Code Terminology	C49961	Foil Device	A thin, flexible sheet of metal.	Foil	818	A thin, flexible sheet of metal.	IMDRF:G04056
C54577	CDRH Component Code Terminology	C171981	Gas Exchanger Device	Component that is used to transfer gasses between two or more locations.	Gas Exchanger	4739	Component that is used to transfer gasses between two or more locations.	IMDRF:G04057
C54577	CDRH Component Code Terminology	C49968	Gasket Device	A preformed material designed to form a seal between connecting surfaces.	Gasket	823	A preformed material designed to form a seal between connecting surfaces.	IMDRF:G04058
C54577	CDRH Component Code Terminology	C49969	Gear Device	A toothed wheel designed to mesh with another toothed object and transmit motion.	Gears	565	A toothed wheel designed to mesh with another toothed object and transmit motion.	IMDRF:G04059
C54577	CDRH Component Code Terminology	C49970	Generator Device	An engine designed to produce electricity or a device designed to produce a vapor or gas.	Generator	825	A component designed to produce electricity, vapor or gas.	IMDRF:G04060
C54577	CDRH Component Code Terminology	C49974	Guide Device	A device designed to help direct the passage of another object.	Guide	829	A component designed to help direct the passage of another object.	IMDRF:G04061
C54577	CDRH Component Code Terminology	C50271	Guidewire Device	A flexible wire designed to help position medical devices within the body.	Guidewire	463	A flexible wire designed to help position medical devices within the body.	IMDRF:G04062
C54577	CDRH Component Code Terminology	C50275	Handpiece Device	A part of a mechanical device designed to be used while held in the hand.	Handpiece	3067	A part of a device designed to be used while held in the hand.	IMDRF:G04063
C54577	CDRH Component Code Terminology	C49978	Header Device	A pipe containing multiple feeder pipes, especially the exhaust pipe that connects to each cylinder of an engine.	Header	464	The connection point between the leads and the generator.	IMDRF:G04064
C54577	CDRH Component Code Terminology	C172033	Sewing Ring Device	A ring of supportive material designed to provide a stable surface for attachment to surrounding tissues.	Sewing Ring	4740	A ring of supportive material designed to provide a stable surface for attachment to surrounding tissues.	IMDRF:G04065
C54577	CDRH Component Code Terminology	C49984	Heat Exchanger Device	A device designed to transfer heat between fluids across a barrier or to the environment.	Heat Exchanger	835	A component designed to transfer heat between fluids and/or gases across a barrier or to the environment.	IMDRF:G04066
C54577	CDRH Component Code Terminology	C49988	Hinge Device	A device designed to join two objects and allow them to swing relative to one another.	Hinge	837	A component designed to join two objects and allow them to swing relative to one another.	IMDRF:G04067
C54577	CDRH Component Code Terminology	C49989	Holder Device	A device designed to hold another object.	Holder	838	A component designed to hold another object.	IMDRF:G04068
C54577	CDRH Component Code Terminology	C50279	Hose Device	A flexible tube designed to carry a fluid.	Hose	3072	A flexible tube designed to carry a fluid or gas.	IMDRF:G04069
C54577	CDRH Component Code Terminology	C49990	Housing Device	A structural enclosure designed to contain or support a device.	Housing	839	A rigid casing that encloses and protects a piece of equipment.	IMDRF:G04070
C54577	CDRH Component Code Terminology	C49992	Humidifier Device	A device designed to add moisture to the air.	Humidifier	470	A component used to increase moisture in a gas.	IMDRF:G04071
C54577	CDRH Component Code Terminology	C50312	Hydraulic System Device	A system designed to use fluid pressure to bring about movement.	Hydraulic System	3075	A system designed to use fluid pressure to bring about movement.	IMDRF:G04072
C54577	CDRH Component Code Terminology	C171990	Impeller Device	The rotating component of a centrifugal pump, compressor, or other machine designed to move a fluid by rotation.	Impeller	4741	The rotating component of a centrifugal pump, compressor, or other machine designed to move a fluid by rotation.	IMDRF:G04073
C54577	CDRH Component Code Terminology	C171997	Inserter Device	A component whose function is to facilitate the insertion of a particular device.	Inserter	4742	A component whose function is to facilitate the insertion of a particular device.	IMDRF:G04074
C54577	CDRH Component Code Terminology	C50004	Insulation Device	A material designed to reduce the transmission of heat, sound, or electricity.	Insulation	473	A material designed to reduce the transmission of heat, sound, or electricity.	IMDRF:G04075
C54577	CDRH Component Code Terminology	C50011	Isolator Device	Any material or structure designed to limit the interaction between two components.	Isolator	852	Any material or structure designed to limit the interaction between two components.	IMDRF:G04076
C54577	CDRH Component Code Terminology	C54020	Jaw Device	A device designed to use opposing parts to close on and hold an object.	Jaw	1028	A component designed to use opposing parts to close on and hold an object.	IMDRF:G04077
C54577	CDRH Component Code Terminology	C50013	Joint Device	A device designed as the junction between objects; it may be flexible or rigid.	Joint	854	A component designed as the junction between objects; it may be flexible or rigid.	IMDRF:G04078
C54577	CDRH Component Code Terminology	C50022	Knob Device	A handle, usually attached to a shaft allowing manual rotation of the shaft.	Knob	861	A rounded lump or ball used for adjusting or controlling.	IMDRF:G04079
C54577	CDRH Component Code Terminology	C50023	Label Device	Any written, printed, or graphic matter upon a device to identify its nature, ownership, or other characteristic particulars of the device.	Label	862	Any written, printed, or graphic matter upon a device to identify its nature, ownership, or other characteristics of the device.	IMDRF:G04080
C54577	CDRH Component Code Terminology	C172797	Lever	A rigid bar that rotates around a fixed point.	Lever	4771	A rigid bar that rotates around a fixed point.	IMDRF:G04082
C54577	CDRH Component Code Terminology	C49962	Foot Pedal Device	A lever designed to be operated with the foot.	Foot Pedal	819	A lever designed to be operated with the foot.	IMDRF:G0408201
C54577	CDRH Component Code Terminology	C62126	Cavity Liner	A material placed between the restoration and the tooth surface.	Liner	4743	A component placed the inside of the walls of a cavity or container for protection or insulation.	IMDRF:G04083
C54577	CDRH Component Code Terminology	C50039	Magazine Device	A compartment in a device designed to house a consumable material for feeding into a mechanism.	Magazine/Cassette	4744	A compartment in a device designed to house a consumable material for feeding into a mechanism.	IMDRF:G04084
C54577	CDRH Component Code Terminology	C50044	Manifold Device	A branched system of pipes, typically those that attach to an engine to carry away exhaust.	Manifold	483	A branched system of pipes or channels; typically to funnel the flow of liquids or gases.	IMDRF:G04085
C54577	CDRH Component Code Terminology	C86570	Mask	A protective covering worn over the face, or an apparatus for administering anesthesia or oxygen through the nose or mouth.	Mask	4745	A flexible, form-shaped component designed to be placed over the nose and/or mouth.	IMDRF:G04086
C54577	CDRH Component Code Terminology	C172142	Mechanical Mixer	A mechanical component designed to blend materials.	Mechanical Mixer	4762	A mechanical component designed to blend materials.	IMDRF:G04087
C54577	CDRH Component Code Terminology	C50046	Membrane Device	A device that is made from or resembles a thin flexible sheet of material.	Membrane	484	A component that is made from or resembles a thin flexible sheet of material acting as a boundary or separating two chambers.	IMDRF:G04088
C54577	CDRH Component Code Terminology	C71222	Mesh	A traditional unit of length defined as the number of opening per inch of a screen, e.g. the number of strands or particles per inch.	Mesh	4746	Component made of overlapping strands forming a fine net-like structure.	IMDRF:G04089
C54577	CDRH Component Code Terminology	C50077	Motor Device	A device designed to convert energy into mechanical motion.	Motor(s)	486	A machine that converts any form of energy to produce or impart motion (kinetic energy).	IMDRF:G04090
C54577	CDRH Component Code Terminology	C50079	Mount Device	A structural device designed to facilitate the attachment of one object to another.	Mount	887	A structural component designed to facilitate the attachment of one object to another.	IMDRF:G04091
C54577	CDRH Component Code Terminology	C50290	Needle Device	A device part with a long, slender, pointed shape.	Needle	3088	A component with a long, slender, pointed shape.	IMDRF:G04092
C54577	CDRH Component Code Terminology	C50291	Nozzle Device	A device designed to regulate and direct the flow of a fluid.	Nozzle	3092	A component designed to regulate and direct the flow of a fluid or gas.	IMDRF:G04093
C54577	CDRH Component Code Terminology	C185295	Packaging Materials	Materials used in packaging to protect the contents.	Packaging	4747	The outer wrapping around a device which serves to contain, identify, and protect it prior to use.	IMDRF:G04094
C54577	CDRH Component Code Terminology	C50095	Pad Device	A protective or cushioning material applied to a projecting or supporting surface of a device.	Pad	900	Typically a soft, cushion-like material used to prevent injury or damage to a person or device. Can also be made of an absorbent material to absorb liquid.	IMDRF:G04095
C54577	CDRH Component Code Terminology	C50096	Panel Device	A rigid sheet that forms a surface of a device or component.	Panel	901	A rigid sheet that forms a surface of a device or component.	IMDRF:G04096
C54577	CDRH Component Code Terminology	C50106	Plate Device	A sheet of metal or wood or glass or plastic.	Plate	907	A thin, flat sheet or strip used to join, strengthen or to form parts of another structure.	IMDRF:G04097
C54577	CDRH Component Code Terminology	C50108	Plug Device	A device designed to seat into an opening in a device.	Plug	579	A component designed to seat into an opening in a device or other object.	IMDRF:G04098
C54577	CDRH Component Code Terminology	C50297	Plunger Device	A mechanical device designed to slide within a chamber to transfer a material.	Plunger	3098	A component of a machine, tool or device that pushes or thrusts another object, liquid or gas.	IMDRF:G04099
C54577	CDRH Component Code Terminology	C50112	Post Device	A structural device part that supports or aligns other parts.	Post	912	An upright piece that is fixed firmly that supports, place or aligns other parts.	IMDRF:G04100
C54577	CDRH Component Code Terminology	C172798	Potting	The resin, glue or other substance used to seal other components together.	Potting	4772	The resin, glue or other substance used to seal other components together.	IMDRF:G04101
C54577	CDRH Component Code Terminology	C50121	Probe Device	A device designed to reach into a location for manipulating or sensing.	Probe	918	A component designed to reach into a location for manipulating or for measuring.	IMDRF:G04102
C54577	CDRH Component Code Terminology	C50122	Processor Device	A device designed for preparing or treating a material.	Processor	919	A component designed for preparing or treating a material. Should not be used for computer processors.	IMDRF:G04103
C54577	CDRH Component Code Terminology	C50126	Pulley Device	A wheel with a groove in it designed to change the direction of force of a rope or belt that runs over it.	Pulley	923	A component which changes the direction of a force (e.g. belt or chain).	IMDRF:G04104
C54577	CDRH Component Code Terminology	C50128	Pump Device	A device designed to facilitate the movement of a fluid.	Pump	925	A component designed to facilitate the movement of a fluid.	IMDRF:G04105
C54577	CDRH Component Code Terminology	C54023	Pusher Device	A device designed to advance something by pushing it.	Pusher	3157	A component designed to advance something by pushing it.	IMDRF:G04106
C54577	CDRH Component Code Terminology	C172799	Rachet	A device part that allows or forces another part's movement in a single direction.	Rachet	4773	A part that allows or forces another part's movement in a single direction.	IMDRF:G04107
C54577	CDRH Component Code Terminology	C50130	Rail Device	A bar designed for support, attachment, guidance, or protection from falling.	Rail	927	A bar designed for support, attachment, guidance, or protection from falling.	IMDRF:G04108
C54577	CDRH Component Code Terminology	C50301	Side Rail Device	A supportive or protective rail attached to the side of something.	Side Rail	3107	A supportive or protective rail attached to the side of something.	IMDRF:G0410801
C54577	CDRH Component Code Terminology	C50137	Regulator Device	Any device designed to control a process or condition.	Regulator	932	A component designed to control a process or condition.	IMDRF:G04109
C54577	CDRH Component Code Terminology	C50140	Reservoir Device	A vessel designed to store a fluid.	Reservoir	934	A vessel designed to store a fluid.	IMDRF:G04110
C54577	CDRH Component Code Terminology	C50148	Ring Device	Any doughnut-shaped device.	Ring	943	A circular band-shaped component.	IMDRF:G04111
C54577	CDRH Component Code Terminology	C50153	Rod Device	Any rod-shaped device.	Rod/Shaft	4721	A long cylindrical bar used to transmit motion or connect other components.	IMDRF:G04112
C54577	CDRH Component Code Terminology	C50163	Seal Device	A device designed to prevent passage of some material through a joint or opening.	Seal	432	A component designed to prevent passage of material through a joint or opening.	IMDRF:G04113
C54577	CDRH Component Code Terminology	C172139	Shock Absorber Device	A mechanical component designed to dampen or attenuate a force.	Shock Absorber	4722	A mechanical component designed to dampen or attenuate a force.	IMDRF:G04114
C54577	CDRH Component Code Terminology	C49755	Device Component or Accessory	A physical object that is a device or a component or accessory of a device.	Sleeve	4723	A cylindrical fitting that slides over another part of a device or other object.	IMDRF:G04115
C54577	CDRH Component Code Terminology	C50178	Slide Device	A flat rectangular piece of glass on which specimens can be mounted for microscopic study.	Slide	963	A flat rectangular piece of glass on which specimens can be mounted for microscopic study.	IMDRF:G04116
C54577	CDRH Component Code Terminology	C50180	Socket Device	A device designed as an opening into which something else fits.	Socket	967	A component designed as an opening into which something else fits.	IMDRF:G04117
C54577	CDRH Component Code Terminology	C50182	Spacer Device	A device designed to position objects further apart.	Spacer	969	A component designed to position objects further apart.	IMDRF:G04118
C54577	CDRH Component Code Terminology	C50187	Spring Device	An elastic device designed to bend under a load and then return to its shape when unloaded.	Spring	975	An elastic component designed to bend under a load and then return to its shape when unloaded.	IMDRF:G04119
C54577	CDRH Component Code Terminology	C50189	Stand Device	A support device designed to hold an object.	Stand	977	A support component designed to hold an object.	IMDRF:G04120
C54577	CDRH Component Code Terminology	C50337	Steering Wire Device	A wire designed to connect to a steering device.	Steering Wire	3111	A wire designed to enable a device to be maneuvered.	IMDRF:G04121
C54577	CDRH Component Code Terminology	C50190	Stent Device	A device designed to support a tubular structure, especially the small stainless steel expandable mesh tube inserted within an artery.	Stent	515	Tubular support placed inside a blood vessel, canal, or duct to aid healing or relieve an obstruction.	IMDRF:G04122
C54577	CDRH Component Code Terminology	C50192	Stopcock Device	A rotating device designed to act like a faucet for regulating the flow of a fluid.	Stopcock	517	A rotating component designed to act like a tap for regulating the flow of a fluid, and to completely stop the flow when closed fully.	IMDRF:G04123
C54577	CDRH Component Code Terminology	C96139	Stopper Container Closure	Object used to plug opening of container.	Stopper	4724	Component designed to close an opening. || Object used to plug opening of container.	IMDRF:G04124
C54577	CDRH Component Code Terminology	C50193	Strain Relief Device	A structure designed to function with a connector to prevent damage to a hose or cable from excess flexing.	Strain Relief	979	A structure designed to function with a connector to prevent damage to a hose or cable from excess flexing.	IMDRF:G04125
C54577	CDRH Component Code Terminology	C50195	Stylet Device	A thin metal wire designed to be passed through a needle, catheter, or cannula to stiffen it or clear it of debris.	Stylet	518	A thin metal wire designed to be passed through a needle, catheter, or cannula to stiffen it or clear it of debris.	IMDRF:G04126
C54577	CDRH Component Code Terminology	C50207	Syringe Device	A device designed as a rigid cylinder with a plunger at one end and a delivery opening at the other.	Syringe	987	A component designed as a rigid cylinder with a plunger at one end and a delivery opening at the other.	IMDRF:G04127
C54577	CDRH Component Code Terminology	C50371	Table Device	A piece of furniture having a smooth flat top that is usually supported by one or more vertical legs, or any object of a similar appearance.	Table	3117	A component having a smooth flat surface that is usually supported by one or more vertical legs.	IMDRF:G04128
C54577	CDRH Component Code Terminology	C50324	Tip Device	The extreme end of something, especially something pointed.	Tip	3123	Pointed or rounded end of an object.	IMDRF:G04129
C54577	CDRH Component Code Terminology	C172800	Tool	A component that is not part of a device but is designed to support its assemby or operation.	Tool	4774	A component that is delivered with a device to support its assembly or operation, and is not part of the device. Use only in the case there are no other terms to describe the component.	IMDRF:G04130
C54577	CDRH Component Code Terminology	C172801	Translational Motion Component	A rotating part of a device which is intended to transfer rotational movement or motion to another type of movement.	Translational Motion Component	4775	A rotating part which is intended to transfer rotational movement or motion to another type of movement (e.g. excenters).	IMDRF:G04131
C54577	CDRH Component Code Terminology	C171979	Fluid/BubbleTrap	A component designed to capture or remove bubbles or fluid.	Trap	4725	A component designed to capture or remove bubbles or fluid.	IMDRF:G04132
C54577	CDRH Component Code Terminology	C50327	Trocar Device	A sharp, pointed rod designed to pierce the wall of a body cavity to withdraw fluid or allow placement of a catheter or other device.	Trocar	3126	A sharp, pointed rod designed to pierce the wall of a body cavity to withdraw fluid or allow placement of a catheter or other device.	IMDRF:G04133
C54577	CDRH Component Code Terminology	C50236	Tube Device	Any device or component shaped like a hollow cylinder.	Tube	525	A long hollow cylinder, either rigid or flexible, for holding or transporting liquids or gasses.	IMDRF:G04134
C54577	CDRH Component Code Terminology	C50237	Capillary Tube Device	A tube with a narrow diameter designed to hold a liquid by capillary action.	Capillary Tube	587	A narrow tube in which a liquid flows up against gravity.	IMDRF:G0413401
C54577	CDRH Component Code Terminology	C50243	Valve Device	A mechanical device designed to control the flow of a fluid.	Valve(s)	527	A mechanical component designed to control the flow of a fluid or gas.	IMDRF:G04135
C54577	CDRH Component Code Terminology	C50244	Control Valve Device	A valve designed to regulate the flow of a fluid, especially one designed to operate in response to a signal from a control system.	Control Valve	529	A valve designed to regulate the flow of a fluid or gas.	IMDRF:G0413501
C54577	CDRH Component Code Terminology	C50260	Luer Valve Device	A valve that incorporates a Luer fitting.	Luer Valve	481	A valve that incorporates a Luer fitting.	IMDRF:G0413502
C54577	CDRH Component Code Terminology	C50334	One-Way Valve Device	A valve designed to allow flow in only one direction.	One-Way Valve	3094	A valve designed to allow flow in only one direction.	IMDRF:G0413503
C54577	CDRH Component Code Terminology	C50262	Vaporizer Device	A device designed to convert a solution to an aerosol or mist, especially one to prepare a medication for inhaling.	Vaporiser	543	A component for gasifying liquids such as drugs.	IMDRF:G04136
C54577	CDRH Component Code Terminology	C50265	Vibrator Device	A mechanical device designed to create a vibratory motion.	Vibrator	3148	A mechanical component designed to create a vibratory motion.	IMDRF:G04137
C54577	CDRH Component Code Terminology	C50267	Washer Device	A device designed to cleanse an object, or a flattened disk used as a mechanical seal between objects.	Washer	3150	A flattened disk used as a mechanical seal between objects.	IMDRF:G04138
C54577	CDRH Component Code Terminology	C89532	Weld Device	Any joining connection that is the result of welding 2 or more parts.	Weld	3195	Any joining connection that is the result of welding 2 or more parts.	IMDRF:G04139
C54577	CDRH Component Code Terminology	C51067	Wheel Device	A mechanical device consisting of a spoked, circular rim or solid disk designed to rotate on an axle or shaft.	Wheel	3130	A mechanical component consisting of a spoked, circular rim or solid disk designed to rotate on an axle or shaft.	IMDRF:G04140
C54577	CDRH Component Code Terminology	C50268	Window Device	A transparent panel in a device designed for visual inspection.	Window	3152	A transparent panel in a device designed for visual inspection or to let light pass.	IMDRF:G04141
C54577	CDRH Component Code Terminology	C50175	Shutter Device	A mechanical or electronic device designed to regulate an exposure time, especially the one in a camera.	Shutter	960	Aperture that controls or blocks light or radiation passing through.	IMDRF:G04142
C54577	CDRH Component Code Terminology	C49858	Camera Device	An apparatus for taking photographs, generally consisting of a lightproof enclosure having an aperture with a shuttered lens through which the image of an object is focused and recorded on a photosensitive film or plate.	Camera	748	An apparatus for taking photographs, generally consisting of a lightproof enclosure having an aperture with a shuttered lens through which the image of an object is focused and recorded.	IMDRF:G05001
C54577	CDRH Component Code Terminology	C49955	Film Device	A photographic material designed to capture an image upon exposure to electromagnetic radiation.	Film	815	A photographic material designed to capture an image upon exposure to electromagnetic radiation.	IMDRF:G05002
C54577	CDRH Component Code Terminology	C49997	Imager Device	A device designed to create or record a visual representation of something.	Imager	841	A component designed to create or record a visual representation.	IMDRF:G05003
C54577	CDRH Component Code Terminology	C50026	Laser Device	A device designed to emit a monochromatic beam of coherent light.	Laser	865	A component designed to emit a monochromatic beam of coherent light.	IMDRF:G05004
C54577	CDRH Component Code Terminology	C49923	Light Emitting Diode Device	A type of diode designed to emit light when a current passes through it.	LED (Light Emitting Diode)	477	A type of diode designed to emit light when a current passes through it.	IMDRF:G05005
C54577	CDRH Component Code Terminology	C50030	Lens Device	An electric or optical device designed to focus electromagnetic radiation.	Lenses	866	An electric or optical component designed to focus (concentrate) or disperse electromagnetic radiation.	IMDRF:G05006
C54577	CDRH Component Code Terminology	C172002	Light Source	A component that produces visible light.	Light Source	4749	A component that produces visible light.	IMDRF:G05007
C54577	CDRH Component Code Terminology	C171946	Light/Heat Bulb Device	A component designed to produce light or heat.	Bulb	4750	A component designed to produce light or heat.	IMDRF:G0500701
C54577	CDRH Component Code Terminology	C50070	Mirror Device	A device consisting of a polished surface designed to reflect light.	Mirror	882	A component consisting of a polished surface designed to reflect light.	IMDRF:G05008
C54577	CDRH Component Code Terminology	C49954	Optical Fiber Device	A device made with thin glass fibers as a conduit for transmission of light.	Optical Fiber	546	A component made with thin glass fibers as a conduit for transmission of light.	IMDRF:G05009
C54577	CDRH Component Code Terminology	C49813	Alarm Device	A device designed to signal the occurrence of a particular event.	Alarm	403	A component designed to signal the occurrence of a particular event.	IMDRF:G06001
C54577	CDRH Component Code Terminology	C49814	Audible Alarm Device	A device designed to signal the occurrence of a particular event by making a sound.	Alarm, Audible	405	A component designed to signal the occurrence of a particular event by making a sound.	IMDRF:G0600101
C54577	CDRH Component Code Terminology	C49822	Visual Alarm Device	A device designed to signal the occurrence of a particular event in a way that can be seen.	Alarm, Visual	413	A component designed to signal the occurrence of a particular event in a way that can be seen.	IMDRF:G0600102
C54577	CDRH Component Code Terminology	C50308	Emergency Stop Button Device	A button and circuits designed to force the shutdown of a machine or device.	Emergency Button Or Switch	3054	A button and circuits designed to force the shutdown of a machine or device.	IMDRF:G06002
C54577	CDRH Component Code Terminology	C50208	Fail-Safe System Device	A device designed to prevent malfunction, unsafe, or unauthorized operation of a device or system.	Fail-Safe System	456	A component designed to prevent malfunction, unsafe, or unauthorized operation of a device or system.	IMDRF:G06003
C54577	CDRH Component Code Terminology	C50286	Locking Mechanism Device	A fastening device designed to hold, close, or secure.	Locking Mechanism	3083	A fastening component designed to hold, close, or secure.	IMDRF:G06004
C54577	CDRH Component Code Terminology	C50171	Shield Device	A device designed to form a protective covering or structure.	Protector/Shield	4752	A component designed to prevent harm or protect against damage to other components.	IMDRF:G06005
C54577	CDRH Component Code Terminology	C50154	Safety Interlock Device	A mechanical or electronic device designed to prevent one action from happening when certain conditions exist.	Safety Interlock	947	A mechanical or electronic component designed to prevent undesired actions due to the changing state of a device, typically to prevent harm to an operator or damage to the device itself.	IMDRF:G06006
C54577	CDRH Component Code Terminology	C172013	Needle Stick Prevention Mechanism	A mechanism integrated into an injectable device to prevent needle stick injuries.	Needle Stick Prevention Mechanism	4753	A mechanism integrated into a device to prevent needle stick injuries.	IMDRF:G0600601
C54577	CDRH Component Code Terminology	C50257	Safety Valve Device	A valve designed to automatically open in order to maintain the pressure in a system below a specified pressure.	Safety Valve	541	A valve designed to automatically open in order to maintain the pressure in a system below a specified pressure.	IMDRF:G06007
C54577	CDRH Component Code Terminology	C172015	Part/Component/Sub-assembly Term not Applicable	The device does not have distinct parts, components, or sub-assemblies, or it would not be appropriate to link the reported incident to a single part, component, or sub-assembly.	Part/Component/Sub-assembly Term not Applicable	4755	The device does not have distinct parts, components, or sub-assemblies, or it would not be appropriate to link the reported incident to a single part, component, or sub-assembly. Use this term if the problem involves or affects the overall device rather than a specific component.	IMDRF:G07001
C54577	CDRH Component Code Terminology	C171943	Appropriate Component Term/Code Not Available	The parts, components, or sub-assemblies are not adequately described by any other term.	Appropriate Term/Code Not Available	4756	The parts, components, or sub-assemblies are not adequately described by any other term. Note: this code must not be used unless there is no other feasible code. The preferred term should be documented when submitting an adverse event report. This information will be used to determine if a new term should be added to the code table.	IMDRF:G07002
C54577	CDRH Component Code Terminology	C187378	Insufficient Information to Classify Device	There is not yet enough information available to classify the medical device component.	Insufficient Information	4776	There is not yet enough information available to classify the medical device component.	IMDRF:G07003