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 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. 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 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, gas or radiation from the vessel or container in which it is housed. IMDRF:A0504 C54451 CDRH Medical Device Problem Code Terminology C63137 Fluid Leak Escape (release, discharge) of fluid through an unintended location that is often accompanied by a loss of pressure and/or output. Fluid Leak 1250 Escape (Release, Discharge) of fluid through an unintended location - often accompanied by a loss of pressure and/or output. IMDRF:A050401 C54451 CDRH Medical Device Problem Code Terminology C63127 Gas Leak Problem associated with the unintended escape of a gas from the container in which it is housed. Gas Leak 2946 Problem associated with the unintended escape of a gas from the container in which it is housed. 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 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 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 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 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 becoming nonfunctional of an application program. Application Program Freezes, Becomes Nonfunctional 4031 Problem associated with freezing and 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 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 Settings Problem associated with the use of the device in terms of inappropriate and false control setting 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 and false control setting 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. Relevant testing would typically be based on test methods used for evaluating safety and performance as described 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 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 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 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 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 C50669 Nerve Damage Injury to nervous tissue. Nerve Damage 1979 Injury to nervous tissue. IMDRF:E0123 C54450 CDRH Health Effect - Clinical Code Terminology C50849 Optical 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 Cerebrovascular Accident 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 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 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 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 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 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 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/Bleeding 1888 The loss of blood from a ruptured blood vessel. 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 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 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 C50450 Acanthamoeba Keratitis Keratitis due to infection by acanthamoeba; it is usually associated with soft contact lens wear, particularly overnight wear. Acanthamoeba Keratitis 1945 Keratitis due to 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 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 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 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 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.. Pyrosis/Heartburn 1883 Abdominal discomfort with retrosternal pain usually associated with gastroesophageal reflux. 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 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 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 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. Diabetic Ketoacidosis 2364 A type of 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 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 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 Aseptic fibrosis or local necrosis secondary to metal corrosion and release of wear debris. It's also known as Metallosis. 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 C50658 Muscle Weakness A reduction in the strength of one or more muscles. Muscle Weakness 1967 A reduction in the strength 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 Bone Fracture 2369 Broken bone that doesn't heal. 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 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 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 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 peripheral (mature) T-cell lymphoma, consisting of usually large anaplastic, CD30 positive cells. The majority of cases are positive for the anaplastic large cell lymphoma (ALK) protein. 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 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 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 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 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 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