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
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
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
C139470
Cause Cannot be Traced to Device
The adverse event that occurred is not attributable to a device.
Cause Cannot be Traced to Device
4310
The adverse event that occurred is not attributable to a device.
IMDRF:D10
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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 (including both short or long term known complications or adverse reactions).
IMDRF:D12
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
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
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
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
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 wilful 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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
C92083
No Device Problem Found
The device either functioned as intended or a problem was not found.
No Device Problem Found
213
The device either functioned as intended or a problem was not found.
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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.
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
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
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
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
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
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
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
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
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
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
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
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
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
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:G0101
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:G0401
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:G0402
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:G0403
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:G044601
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:G0404
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:G0601
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:G060101
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:G060102
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:G0301
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:G0405
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:G0201
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:G0302
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:G0406
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 Component 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:G0702
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:G0407
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:G0408
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:G0409
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:G0410
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:G0202
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:G0203
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:G0411
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 loop of material moving over shafts or pulleys.
IMDRF:G0412
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:G044602
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:G0413
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:G0414
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:G0415
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:G031101
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:G050701
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:G0416
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:G020401
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:G020402
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:G0204
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:G0417
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:G0303
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:G0501
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:G0418
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 small metal or plastic component that connects to the cannula.
IMDRF:G041801
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:G0419
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:G021301
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
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:G0420
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:G0421
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:G0422
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:G042201
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:G0102
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:G0423
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:G0424
C54577
CDRH Component Code Terminology
C171955
Chamber
A component designed as a reservoir/storage.
Chamber
4731
A component designed as a reservoir/storage.
IMDRF:G0425
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:G0426
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:G0205
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:G0206
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:G044603
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:G044604
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:G0304
C54577
CDRH Component Code Terminology
C172796
Fabric
Cloth produced from textile fibers.
Cloth
4770
Cloth produced from textile fibers.
IMDRF:G04050
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:G0427
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:G0428
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
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:G0207
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:G020701
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:G0208
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:G0429
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:G0430
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:G043101
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:G0431
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:G0412401
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:G0432
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:G0209
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:G0305
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:G0433
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:G0434
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:G0435
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
439
Part of an implantable medical device, usually cardiovascular valves, designed to prevent retrograde flow of blood (or other biological fluid) but not impede a forward flow.
IMDRF:G0436
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:G0437
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
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:G0438
C54577
CDRH Component Code Terminology
C49909
Defibrillator Paddle Device
The part of a defibrillator designed to be placed in contact with the body.
Defibrillator Paddles
442
The part of a defibrillator designed to be placed in contact with the body.
IMDRF:G0210
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:G0439
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:G0103
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:G0211
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:G0212
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:G0440
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:G0213
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.
IMDRF:G0214
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:G0441
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:G020801
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:G0442
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:G0215
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:G0216
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:G0217
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:G021501
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:G0602
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:G0218
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:G0443
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:G0444
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:G0603
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:G0445
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:G0446
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:G0447
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:G0502
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:G0448
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:G044605
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:G0449
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:G030601
C54577
CDRH Component Code Terminology
C49961
Foil Device
A thin, flexible sheet of metal.
Foil
818
A thin, flexible sheet of metal.
IMDRF:G0450
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:G0451
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:G021302
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:G0452
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:G0104
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:G0453
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:G0306
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:G0454
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:G0455
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:G021502
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:G0456
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:G0457
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:G0458
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:G0459
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:G0219
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:G0461
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:G0220
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:G042701
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:G0462
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:G0463
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:G0464
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:G0465
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:G0221
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:G0466
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:G0467
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:G021303
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:G0503
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:G0468
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:G021401
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:G021304
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:G0469
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:G0470
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:G0222
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:G0471
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:G0472
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:G0473
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:G024001
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:G024002
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:G0474
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:G0475
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:G0504
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:G044606
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:G022501
C54577
CDRH Component Code Terminology
C50283
Leaflet Device
Any device that resembles a small leaf, especially one that has two thin blades hinged in the center.
Leaflet
3081
A device consisting of two thin blades hinged in the center; typically designed to control flow of fluids.
IMDRF:G0476
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:G0505
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:G0506
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
C172002
Light Source
A component that produces visible light.
Light Source
4749
A component that produces visible light.
IMDRF:G0507
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:G0477
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:G0604
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:G0412402
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:G0478
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:G0223
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:G0479
C54577
CDRH Component Code Terminology
C172005
Manometer Device
A component designed to measure pressure.
Manometer
4716
A component designed to measure pressure.
IMDRF:G030602
C54577
CDRH Component Code Terminology
C16342
Biomarker
A characteristic that can be objectively measured and serves as an indicator for normal biologic processes, pathogenic processes, state of health or disease, the risk for disease development and/or prognosis, or responsiveness to a particular therapeutic intervention.
Marker
4717
A characteristic that is objectively measured and evaluated as an indicator of normal biologic processes, pathogenic processes, or pharmacologic responses to a therapeutic intervention. (From: FDA Guidance for Industry: Pharmacogenomic Data Submissions.) || A visual indicator of position, place or route.
IMDRF:G0307
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:G0480
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:G0481
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:G0482
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:G020702
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:G0483
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:G024003
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:G0508
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 bone cement.
IMDRF:G0105
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:G0484
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:G0485
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:G044607
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:G0486
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:G060601
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:G020703
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:G0487
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:G044608
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:G031102
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:G0412403
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:G0509
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:G0224
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:G030101
C54577
CDRH Component Code Terminology
C84731
Packing
Performance of the packaging part of the manufacturing process.
Packaging
4747
Performance of the packaging part of the manufacturing process. || The outer wrapping around a device which serves to contain, identify, and protect it prior to use.
IMDRF:G0488
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:G0489
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:G0490
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.
IMDRF:G0701
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.
IMDRF:G022502
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:G0225
C54577
CDRH Component Code Terminology
C49917
Photodetector Device
A device designed to detect light.
Photodetector
902
A component designed to detect light.
IMDRF:G031103
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:G044609
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:G0308
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:G0491
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:G0492
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:G0493
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:G0309
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 bone cement.
IMDRF:G0107
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:G0494
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
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:G0226
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:G0227
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:G023401
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:G031104
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:G0228
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:G0229
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:G0495
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:G0496
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:G044610
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.
IMDRF:G0605
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:G0497
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:G0498
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:G0499
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:G0230
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:G0231
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:G04100
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:G023402
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:G04101
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:G021305
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:G044611
C54577
CDRH Component Code Terminology
C50148
Ring Device
Any doughnut-shaped device.
Ring
943
A circular band-shaped component.
IMDRF:G04102
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:G044612
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:G04103
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:G0606
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:G0607
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:G0310
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:G0232
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:G021402
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:G044613
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:G04104
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
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:G0311
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:G031105
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:G0460
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:G04105
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
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:G049901
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:G04106
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:G04107
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:G04108
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:G020802
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:G021306
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:G04109
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:G0233
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:G04110
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:G04111
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:G044614
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:G04112
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 temporarily inside a blood vessel, canal, or duct to aid healing or relieve an obstruction.
IMDRF:G04113
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:G04114
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:G04115
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:G04116
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:G04117
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 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.
IMDRF:G044615
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.
IMDRF:G0234
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:G04118
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:G04119
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:G044616
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:G0235
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:G0236
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:G031106
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:G0106
C54577
CDRH Component Code Terminology
C50059
Thermometer Device
A device designed to measure temperature.
Thermometer
3158
A component designed to measure temperature.
IMDRF:G030603
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:G0237
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:G0312
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:G04120
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 assemby 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
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
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:G021307
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:G0238
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
C50231
Transmitter Device
A device to propagate electromagnetic waves.
Transmitter
3141
A component to propagate electromagnetic waves.
IMDRF:G0239
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:G04121
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:G04122
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:G04123
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:G0240
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:G020803
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:G04124
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:G04125
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:G04126
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:G04127
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:G04128
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.
IMDRF:G04129
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:G021503
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
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
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
C50795
Abnormal Vaginal Discharge
Abnormal secretions from the vagina.
Abnormal Vaginal Discharge
2123
Secretions from the vagina with a smell, color, or texture which is different from normal.
IMDRF:E1401
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
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
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
C50450
Acanthamoeba Keratitis
Keratitis due to infection by acanthamoeba; it is usually associated with soft contact lens wear, particularly overnight wear.
Acanthameba Keratitis
1945
Keratitis due to infection by acanthamoba.
IMDRF:E082901
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
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
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
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
C116374
Ageusia
Inability to taste.
Ageusia
4423
Inability to taste.
IMDRF:E013501
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
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
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
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
C50459
Amnionitis
Inflammation of the amnion.
Amnionitis
2217
Inflammation of the amnion.
IMDRF:E1502
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
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
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
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
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
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
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
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
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
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
C26698
Apnea
Transient cessation of respiration.
Apnea
1720
Transient cessation of respiration.
IMDRF:E0703
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 Clinical Signs, Symptoms, Conditions 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
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
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
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
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
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
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
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
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
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
C51220
Insufficient Anesthesia
A state of consciousness that permits the formation of explicit and implicit memories while under general anesthesia.
Awareness during Anesthesia
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
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
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
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 cirrhosis) or blockage of the extrahepatic bile ducts (secondary biliary cirrhosis).
IMDRF:E1101
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
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
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
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
C50473
Bowel Burn
A thermal, chemical or radiation injury to the bowels.
Bowel Burn
1756
A thermal, chemical or radiation 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
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
C50440
Brain Injury
Trauma to the brain.
Brain Injury
2219
Damage to the brain.
IMDRF:E0102
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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 Ventriculomeglia
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
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
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
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
C38665
Chest Pain
Pain in the chest.
Chest Pain
1776
Pain in the chest.
IMDRF:E233001
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
C2875
Anorexia
Loss of appetite.
Decreased Appetite
4569
Lack of desire for food.
IMDRF:E2306
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
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
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
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
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
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
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
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
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
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
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
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
C2987
Diarrhea
Watery bowel movements.
Diarrhea
1811
Frequent, watery bowel movements.
IMDRF:E1008
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
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
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
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
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
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
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
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
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
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
C28145
Dysgeusia
Persistence of unpleasant taste.
Dysgeusia
4424
Distortion of taste.
IMDRF:E013502
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
C2997
Dyspareunia
Painful or difficult coitus.
Dyspareunia
4505
Painful or difficult coitus.
IMDRF:E1405
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
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
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
C2999
Dysuria
Pain or discomfort during urination.
Dysuria
2684
Difficult or painful urination.
IMDRF:E1301
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
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. Discoloration under the skin caused by a bleed underneath. Typically a bruise.
IMDRF:E050601
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
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
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
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
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
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
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
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
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
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 characterized by mental and neurological symptoms.
IMDRF:E0115
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
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
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
C26766
Epistaxis
Bleeding from the nose.
Epistaxis
4458
Nose bleed.
IMDRF:E0718
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
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
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
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
C50552
Excessive Tearing
Profuse lacrimation.
Excessive Tear Production
2235
Profuse lacrimation.
IMDRF:E0817
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
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
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
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
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
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
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
C34602
Ocular Injury
Damage to the eye.
Eye Injury
1845
Damage to the eye.
IMDRF:E0819
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
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
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
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
C50559
Fasciitis
Inflammation process in fascia.
Fasciitis
2375
Inflammation of fascia.
IMDRF:E1608
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
A thermal, chemical or radiation injury to the 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
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
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
C112199
Glossitis
Inflammation of the tongue.
Glossitis
4490
Inflammation of the tongue.
IMDRF:E103101
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
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
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
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
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
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
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
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
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
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
C37964
Hematemesis
Vomiting blood.
Hematemesis
4478
Vomiting blood.
IMDRF:E1016
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
C3090
Hematuria
Blood in the urine.
Hematuria
2558
Blood in the urine.
IMDRF:E1302
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
C116376
Hyperesthesia
Increased sensitivity to tactile stimulation.
Hyperesthesia
4420
Increased sensitivity to tactile stimulation.
IMDRF:E013401
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
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
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
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
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
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
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
C50591
Hypervolemia
Too much fluid in the blood.
Hypervolemia
2664
Too much fluid in the blood.
IMDRF:E0304
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
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
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
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
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
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
C50523
Decreased Core Body Temperature
Abnormally low body temperature.
Hypothermia
1915
Abnormally low body temperature.
IMDRF:E230103
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
C50613
Induced Abortion Finding
Abortion brought on intentionally.
Induced Abortion
2214
Abortion brought on intentionally.
IMDRF:E150103
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 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
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
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
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
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
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
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
C50438
Intracranial Hemorrhage
Bleeding within the cranium.
Intracranial Hemorrhage
1891
Bleeding within the cranium.
IMDRF:E0118
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
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
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
C50621
Iritis
Inflammation of the iris.
Iritis
1940
Inflammation of the iris.
IMDRF:E0828
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
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
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
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
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
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
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
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
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
C26805
Keratitis
Inflammation of the cornea.
Keratitis
1944
Inflammation of the cornea.
IMDRF:E0829
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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 pulmonary atrial pressure, as measured by a catheter introduced into the distal pulmonary artery, is low.
IMDRF:E0508
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
C50669
Nerve Damage
Injury to nervous tissue.
Nerve Damage
1979
Injury to nervous tissue.
IMDRF:E0123
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
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
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
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
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
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 are identified in the patient.
IMDRF:E2403
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
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
C50529
Delayed Union Fracture
A bone fracture that is taking an abnormally long time to heal.
Non-union Bone Fracture
2369
Broken bone that doesn't heal.
IMDRF:E1625
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
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
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
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
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
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
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
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
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
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
C3306
Pancreatitis
Inflammation of the pancreas.
Pancreatitis
4481
Inflammation of the pancreas.
IMDRF:E1021
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
C38003
Phlebitis
Inflammation of a vein.
Phlebitis
2004
Inflammation of a vein.
IMDRF:E0512
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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 orifice or wound.
IMDRF:E231501
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
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
C50721
Quadriplegia
Paralysis of all four limbs.
Quadriplegia
2449
Paralysis of all four limbs.
IMDRF:E012205
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
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
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
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
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
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
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
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
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
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
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
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
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
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
C34979
Retinal Degeneration
Degeneration of the retina.
Retinal Degeneration
2049
Degeneration of the retina.
IMDRF:E0834
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
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
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
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
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
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
C172030
Salivary Hypersecretion
Excessive saliva production.
Salivary Hypersecretion
4486
Excessive saliva production.
IMDRF:E102802
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
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
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
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
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
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
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
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
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
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
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
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
C3327
Skin Discoloration
Abnormal skin coloration.
Skin Discoloration
2074
any abnormal change in skin coloration.
IMDRF:E1716
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
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
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
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
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
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 Tumor
4552
Abnormal mass of tissue that usually does not contain cysts or liquid areas. Solid tumors may be benign (not cancerous), or malignant (cancerous). Different types of solid tumors are named for the type of cells that form them. If tumors are associated with those under the term cancer, these terms should be used.
IMDRF:E1804
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
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
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
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
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
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
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 characterized by a single prolonged seizures or a series of seizures without intervening full recovery of consciousness.
IMDRF:E010904
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
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
C50756
Strangulation
Chocking or arrest of respiration due to occlusion of the air passageway; 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
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
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 symptoms but caused by microorganisms capable of producing easily recognizable diseases.
IMDRF:E1904
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
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
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
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
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
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
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
C50766
Synovitis
Inflammation of a synovial membrane.
Synovitis
2094
Inflammation of a synovial membrane.
IMDRF:E1632
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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 prions for example Creutzfeldt-Jakob disease (CJD) or Bovine Spongiform Encephalopathy (BSE).
IMDRF:E1905
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
C172050
Unspecified Mental, Emotional or Behavioral Problem
An unspecified mental, emotional or behavioral problem.
Unspecified Mental, Emotional or Behavioral Problem
4430
The report describes a non-specific Mental, Emotional or Behavioral 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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
C50807
Vitreous Detachment
Detachment of the vitreous humor from the retina.
Vitreous Detachment
2445
Detachment of the vitreous humor from the retina.
IMDRF:E081906
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
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
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
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
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
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
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
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
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
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
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
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
C171944
Appropriate Health Impact Term/Code Not Available
There is no appropriate Health Impact term or code.
Appropriate Health Impact 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
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
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
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
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
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
C28554
Dead
The cessation of life.
Death
1802
The cessation of life.
IMDRF:F02
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
C50862
Radiation Overdose
A higher than intended cumulative dose of radiation to a single field.
Radiation Overdose
2166
A higher than intended cumulative dose of radiation to a single field.
IMDRF:F100501
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
C52354
Radiation Underdose
An inadequate amount of a radiation treatment.
Radiation Underdose
1510
A lower than intended dose of radiation to a single field.
IMDRF:F100401
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.
Recognized 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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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 SeparationProblem
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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 and shipping
IMDRF:A1802
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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 Resultor 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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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- characterized by intermittent stoppages to the flow.
IMDRF:A140506
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
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
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 as failure is often recurrent.
IMDRF:A071303
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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