C	FDA	C91802	FDA Manufacturer Evaluation Conclusion Code Hierarchy	C139470	Cause cannot be Traced to Device	4310	IMDRF:D10		The adverse event that occurred is not attributable to a device.	The adverse event that occurred is not attributable to a device.	C91802	FDA Manufacturer Evaluation Conclusion Code Hierarchy	
C	FDA	C91800	FDA Manufacturer Evaluation Method Code Hierarchy	C139447	Testing of Device from Same Lot/Batch Returned from User	4101	IMDRF:B03		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.	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.	C91800	FDA Manufacturer Evaluation Method Code Hierarchy	
C	FDA	C91800	FDA Manufacturer Evaluation Method Code Hierarchy	C139448	Testing of Device from Other Lot/Batch Retained by Manufacturer	4102	IMDRF:B04		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.	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.	C91800	FDA Manufacturer Evaluation Method Code Hierarchy	
C	FDA	C91800	FDA Manufacturer Evaluation Method Code Hierarchy	C139449	Testing of Device from Other Lot/Batch Returned from User	4103	IMDRF:B05		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.	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.	C91800	FDA Manufacturer Evaluation Method Code Hierarchy	
C	FDA	C91800	FDA Manufacturer Evaluation Method Code Hierarchy	C139450	Testing of Model Variant	4104	IMDRF:B06		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.	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.	C91800	FDA Manufacturer Evaluation Method Code Hierarchy	
C	FDA	C91800	FDA Manufacturer Evaluation Method Code Hierarchy	C139451	Testing of Raw/Starting Materials	4105	IMDRF:B07		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.	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.	C91800	FDA Manufacturer Evaluation Method Code Hierarchy	
C	FDA	C91800	FDA Manufacturer Evaluation Method Code Hierarchy	C139452	Testing of Patient Sample or Reference Material Using Manufacturer's Device	4106	IMDRF:B08		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.	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.	C91800	FDA Manufacturer Evaluation Method Code Hierarchy	
C	FDA	C91800	FDA Manufacturer Evaluation Method Code Hierarchy	C139453	Testing of Patient Sample or Reference Material Using Reference Method	4107	IMDRF:B09		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.	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.	C91800	FDA Manufacturer Evaluation Method Code Hierarchy	
C	FDA	C91800	FDA Manufacturer Evaluation Method Code Hierarchy	C139454	Testing of Patient Sample or Reference Material Using Competitor's Device	4108	IMDRF:B10		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.	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.	C91800	FDA Manufacturer Evaluation Method Code Hierarchy	
C	FDA	C91800	FDA Manufacturer Evaluation Method Code Hierarchy	C139455	Historical Data Analysis	4109	IMDRF:B11		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.	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.	C91800	FDA Manufacturer Evaluation Method Code Hierarchy	
C	FDA	C91800	FDA Manufacturer Evaluation Method Code Hierarchy	C139456	Trend Analysis	4110	IMDRF:B12		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.	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.	C91800	FDA Manufacturer Evaluation Method Code Hierarchy	
C	FDA	C91800	FDA Manufacturer Evaluation Method Code Hierarchy	C139457	Communication/Interviews	4111	IMDRF:B13		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.	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.	C91800	FDA Manufacturer Evaluation Method Code Hierarchy	
C	FDA	C91800	FDA Manufacturer Evaluation Method Code Hierarchy	C139458	Analysis of Data Provided by User/Third Party	4112	IMDRF:B15		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.	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.	C91800	FDA Manufacturer Evaluation Method Code Hierarchy	
C	FDA	C91800	FDA Manufacturer Evaluation Method Code Hierarchy	C139459	Device Not Manufactured by Reporting Manufacturer	4113	IMDRF:B16		Further information was obtained which established that the manufacturer of the device involved was not the one to which it was initially attributed.	Further information was obtained which established that the manufacturer of the device involved was not the one to which it was initially attributed.	C91800	FDA Manufacturer Evaluation Method Code Hierarchy	
C	FDA	C91800	FDA Manufacturer Evaluation Method Code Hierarchy	C139460	Device Not Returned	4114	IMDRF:B17		The actual device involved in the adverse event was not returned for testing despite requests by manufacturer.	The actual device involved in the adverse event was not returned for testing despite requests by manufacturer.	C91800	FDA Manufacturer Evaluation Method Code Hierarchy	
C	FDA	C91800	FDA Manufacturer Evaluation Method Code Hierarchy	C139461	Device Discarded	4115	IMDRF:B18		The actual device involved in the adverse event had been already discarded and thus irretrievably lost for testing.	The actual device involved in the adverse event had been already discarded and thus irretrievably lost for testing.	C91800	FDA Manufacturer Evaluation Method Code Hierarchy	
C	FDA	C91800	FDA Manufacturer Evaluation Method Code Hierarchy	C139462	Incomplete Device Returned	4116	IMDRF:B19		The device was returned incompletely, lacking parts, components or accessories that would be required for appropriate testing and analysis of root causes.	The device was returned incompletely, lacking parts, components or accessories that would be required for appropriate testing and analysis of root causes.	C91800	FDA Manufacturer Evaluation Method Code Hierarchy	
C	FDA	C91800	FDA Manufacturer Evaluation Method Code Hierarchy	C139463	Device Not Accessible for Testing	4117	IMDRF:B20		The actual device involved in the adverse event is not readily accessible for testing (e.g. remains implanted in patient).	The actual device involved in the adverse event is not readily accessible for testing (e.g. remains implanted in patient).	C91800	FDA Manufacturer Evaluation Method Code Hierarchy	
C	FDA	C91800	FDA Manufacturer Evaluation Method Code Hierarchy	C139464	Type of Investigation Not Yet Determined	4118	IMDRF:B21		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.	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.	C91800	FDA Manufacturer Evaluation Method Code Hierarchy	
C	FDA	C91800	FDA Manufacturer Evaluation Method Code Hierarchy	C139465	Insufficient Information Available	4119	IMDRF:B22		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''.	The information available relating to the reported event is not sufficient to identify either the manufacturer, the device, or other essential information.	C91800	FDA Manufacturer Evaluation Method Code Hierarchy	
C	FDA	C91801	FDA Manufacturer Evaluation Result Code Hierarchy	C139466	Appropriate Term/Code Not Available	4247	IMDRF:C22		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.	Problems is not adequately described by any other term.	C91801	FDA Manufacturer Evaluation Result Code Hierarchy	
C	FDA	C91801	FDA Manufacturer Evaluation Result Code Hierarchy	C139467	Patient Sample Problem	4233	IMDRF:C14		Problems that occurred due to endogenous or exogenous interferent in the sample, or unexpected variation in the target analyte/marker.	Problems that occurred due to endogenous or exogenous interferent in the sample, or unexpected variation in the target analyte/marker.	C91801	FDA Manufacturer Evaluation Result Code Hierarchy	
C	FDA	C91801	FDA Manufacturer Evaluation Result Code Hierarchy	C139468	Transport/Storage Problem Identified	4246	IMDRF:C18		Problems was caused by transport or storage conditions.	Problems was caused by transport or storage conditions.	C91801	FDA Manufacturer Evaluation Result Code Hierarchy	
C	FDA	C91802	FDA Manufacturer Evaluation Conclusion Code Hierarchy	C139469	Appropriate Term/Code Not Available	4316	IMDRF:D17		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.	The concluded cause is not adequately described by any other term.	C91802	FDA Manufacturer Evaluation Conclusion Code Hierarchy	
C	FDA	C91802	FDA Manufacturer Evaluation Conclusion Code Hierarchy	C139471	Cause Not Established	4315	IMDRF:D15		The investigation findings do not lead to a clear conclusion about the cause of the reported adverse event.	The investigation findings do not lead to a clear conclusion about the cause of the reported adverse event.	C91802	FDA Manufacturer Evaluation Conclusion Code Hierarchy	
C	FDA	C91802	FDA Manufacturer Evaluation Conclusion Code Hierarchy	C139472	Cause Traced to Component Failure	4307	IMDRF:D02		Expected or random component failure without any design or manufacturing issue.	Expected or random component failure without any design or manufacturing issue.	C91802	FDA Manufacturer Evaluation Conclusion Code Hierarchy	
C	FDA	C91802	FDA Manufacturer Evaluation Conclusion Code Hierarchy	C139473	Cause Traced to Environment	4309	IMDRF:D06		Problems caused by exposure to environmental conditions outside the expected range.	Problems caused by exposure to environmental conditions outside the expected range.	C91802	FDA Manufacturer Evaluation Conclusion Code Hierarchy	
C	FDA	C91802	FDA Manufacturer Evaluation Conclusion Code Hierarchy	C139474	Cause Traced to Transport/Storage	4308	IMDRF:D04		Problems traced to the inappropriate transport or storage of the device.	Problems traced to the inappropriate transport or storage of the device.	C91802	FDA Manufacturer Evaluation Conclusion Code Hierarchy	
C	FDA	C91802	FDA Manufacturer Evaluation Conclusion Code Hierarchy	C139475	Falsified Device	4314	IMDRF:D13		Devices that deliberately and/or fraudulently misrepresent their identity, composition or source.	Devices that deliberately and/or fraudulently misrepresent their identity, composition or source.	C91802	FDA Manufacturer Evaluation Conclusion Code Hierarchy	
C	FDA	C91802	FDA Manufacturer Evaluation Conclusion Code Hierarchy	C139476	Design Change Validation Inadequate	4306	IMDRF:D0106		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.	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.	C91869	Cause Traced to Device Design	12
C	FDA	C91802	FDA Manufacturer Evaluation Conclusion Code Hierarchy	C139477	Design Inadequate for Purpose	4301	IMDRF:D0101		Problems traced to design/design features of the device that do not support or interfere with the intended purpose of the device.	Problems traced to design/design features of the device that do not support or interfere with the intended purpose of the device.	C91869	Cause Traced to Device Design	12
C	FDA	C91802	FDA Manufacturer Evaluation Conclusion Code Hierarchy	C139478	Human Factors Engineering - Device Difficult to Assemble	4303	IMDRF:D0103		Problems traced to inadequate design of the component parts and/or assembly steps resulting in the device not being able to be assembled correctly.	Problems traced to inadequate design of the component parts and/or assembly steps resulting in the device not being able to be assembled correctly.	C91869	Cause Traced to Device Design	12
C	FDA	C91802	FDA Manufacturer Evaluation Conclusion Code Hierarchy	C139479	Human Factors Engineering - Device Difficult to Operate	4302	IMDRF:D0102		Problems traced to inappropriate and/or inadequate assessment and engineering design of the device to accommodate how or where the device will be used.	Problems traced to inappropriate and/or inadequate assessment and engineering design of the device to accommodate how or where the device will be used.	C91869	Cause Traced to Device Design	12
C	FDA	C91802	FDA Manufacturer Evaluation Conclusion Code Hierarchy	C139480	Human Factors Engineering - Device Difficult to Reprocess	4304	IMDRF:D0104		Problems traced to inadequate design of the reprocessing steps and/or the device resulting in the device remaining unclean.	Problems traced to inadequate design of the reprocessing steps and/or the device resulting in the device remaining unclean.	C91869	Cause Traced to Device Design	12
C	FDA	C91802	FDA Manufacturer Evaluation Conclusion Code Hierarchy	C139481	Missing or Inadequate Safety Measures	4305	IMDRF:D0105		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.	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.	C91869	Cause Traced to Device Design	12
C	FDA	C91802	FDA Manufacturer Evaluation Conclusion Code Hierarchy	C139482	Sabotage or Intentional Misuse	4313	IMDRF:D1107		Problems occurred because of willful damage or reckless misuse. This term indicates that there was an apparent intent to cause damage or injury.	Problems occurred because of willful damage or reckless misuse. This term indicates that there was an apparent intent to cause damage or injury.	C91874	Cause Traced to User	19
C	FDA	C91801	FDA Manufacturer Evaluation Result Code Hierarchy	C139483	Cytotoxicity Problem Identified	4201	IMDRF:C0104		The device was found to have an undesirable level of toxicity to living cells.	The device was found to have an undesirable level of toxicity to living cells.	C92030	Biological Problem Identified	3204
C	FDA	C91801	FDA Manufacturer Evaluation Result Code Hierarchy	C139484	Unintended Presence of Allergens	4202	IMDRF:C0107		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".	Unintended or unexpected presence of allergens in the device.	C92030	Biological Problem Identified	3204
C	FDA	C91801	FDA Manufacturer Evaluation Result Code Hierarchy	C139485	Device Incorrectly Assembled During Reprocessing	4231	IMDRF:C130103		Incorrect assembly of the device following reprocessing.	Incorrect assembly of the device following reprocessing.	C139575	Device Incorrectly Reprocessed	4228
C	FDA	C91801	FDA Manufacturer Evaluation Result Code Hierarchy	C139486	Device Incorrectly Cleaned During Reprocessing	4229	IMDRF:C130101		The cleaning procedure is not followed correctly or used inappropriate cleaning materials.	The cleaning procedure is not followed correctly or used inappropriate cleaning materials.	C139575	Device Incorrectly Reprocessed	4228
C	FDA	C91801	FDA Manufacturer Evaluation Result Code Hierarchy	C139487	Device Incorrectly Disinfected/Sterilized During Reprocessing	4230	IMDRF:C130102		The disinfection/sterilization process was incorrect and/or the wrong products for disinfection/sterilization were used.	The disinfection/sterilization process was incorrect and/or the wrong products for disinfection/sterilization were used.	C139575	Device Incorrectly Reprocessed	4228
C	FDA	C91801	FDA Manufacturer Evaluation Result Code Hierarchy	C139488	Network Communication Problem	4205	IMDRF:C040103		Communications problems between devices within a network system.	Communications problems between devices within a network system.	C92034	Communications Problem Identified	628
C	FDA	C91801	FDA Manufacturer Evaluation Result Code Hierarchy	C139489	Electrical/Electronic Component Problem Identified	4203	IMDRF:C0201		The performance of an electrical or electronic component was found to be inadequate.	The performance of an electrical or electronic component was found to be inadequate.	C92045	Electrical Problem Identified	120
C	FDA	C91801	FDA Manufacturer Evaluation Result Code Hierarchy	C139490	Unintended Emission	4204	IMDRF:C0304		Problems due to unintended emission of electromagnetic energy by the device.	Problems due to unintended emission of electromagnetic energy by the device.	C92046	Electromagnetic Compatibility Problem Identified	197
C	FDA	C91801	FDA Manufacturer Evaluation Result Code Hierarchy	C139491	Ambient Light Problem Identified	4240	IMDRF:C1505		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).	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).	C92051	Environment Problem Identified	331
C	FDA	C91801	FDA Manufacturer Evaluation Result Code Hierarchy	C139492	Contamination of Environment by Device	4238	IMDRF:C1503		Operation of the device results in contamination of the nearby environment e.g. dust, dirt, smoke, heat or biological material.	Operation of the device results in contamination of the nearby environment e.g. dust, dirt, smoke, heat or biological material.	C92051	Environment Problem Identified	331
C	FDA	C91801	FDA Manufacturer Evaluation Result Code Hierarchy	C139493	Environmental Pressure Problem Identified	4239	IMDRF:C1504		Device performance was affected by the pressure, or changes in pressure, of the environment in which it was used.	Device performance was affected by the pressure, or changes in pressure, of the environment in which it was used.	C92051	Environment Problem Identified	331
C	FDA	C91801	FDA Manufacturer Evaluation Result Code Hierarchy	C139494	Device Not Compatible With Another Device	4206	IMDRF:C0403		A device that malfunctions due to being used in combination with, or in the presence of, another device.	A device that malfunctions due to being used in combination with, or in the presence of, another device.	C92070	Interoperability Problem Identified	3213
C	FDA	C91801	FDA Manufacturer Evaluation Result Code Hierarchy	C139495	Unintended Compatibility	4207	IMDRF:C0404		The device was confirmed to be compatible with another device with which the device is intended to be incompatible.	The device was confirmed to be compatible with another device with which the device is intended to be incompatible.	C92070	Interoperability Problem Identified	3213
C	FDA	C91801	FDA Manufacturer Evaluation Result Code Hierarchy	C139496	Inadequate or Incorrect Instructions for Maintenance	4208	IMDRF:C0503		Inadequate or incorrect information in the instructions for maintenance.	Inadequate or incorrect information in the instructions for maintenance.	C92071	Labeling and Instructions for Use/Maintenance	150
C	FDA	C91801	FDA Manufacturer Evaluation Result Code Hierarchy	C139497	Maintenance of Manufacturing Machinery	4242	IMDRF:C1604		Problems caused by failure to maintain manufacturing equipment used to produce the device.	Problems caused by failure to maintain manufacturing equipment used to produce the device.	C92076	Manufacturing Process Problem Identified	170
C	FDA	C91801	FDA Manufacturer Evaluation Result Code Hierarchy	C139498	Inadequate Physicochemical Properties	4209	IMDRF:C0603		Problems that occur due to the physicochemical properties.	Problems that occur due to the physicochemical properties.	C92078	Material and/or Chemical Problem Identified	174
C	FDA	C91801	FDA Manufacturer Evaluation Result Code Hierarchy	C139499	Incorrect Dimension	4211	IMDRF:C0707		Problems caused by incorrect physical dimensions of the device or one of its parts.	Problems caused by incorrect physical dimensions of the device or one of its parts.	C92079	Mechanical Problem Identified	180
C	FDA	C91801	FDA Manufacturer Evaluation Result Code Hierarchy	C139500	Leakage/Seal	4210	IMDRF:C0703		Problems caused by inadequate/broken seal within the device.	Problems caused by inadequate/broken seal within the device.	C92079	Mechanical Problem Identified	180
C	FDA	C91801	FDA Manufacturer Evaluation Result Code Hierarchy	C139501	Incorrect Interpretation of Results/Data	4232	IMDRF:C1304		Problems resulting from the incorrect interpretation by the user of the results or data provided by the device.	Problems resulting from the incorrect interpretation by the user of the results or data provided by the device.	C92088	Operational Problem Identified	114
C	FDA	C91801	FDA Manufacturer Evaluation Result Code Hierarchy	C139502	Light Source Problem Identified	4212	IMDRF:C0802		Problems with the optical properties of a device such as diopter, glare, and irradiance or glistening.	Problems with the optical properties of a device such as diopter, glare, and irradiance or glistening.	C92089	Optical Problem Identified	3224
C	FDA	C91801	FDA Manufacturer Evaluation Result Code Hierarchy	C139503	Packaging Contains Incorrect Device	4245	IMDRF:C160504		Problems that occurred because the packaging contained an incorrect device.	Problems that occurred because the packaging contained an incorrect device.	C92094	Packaging Problem Identified	111
C	FDA	C91801	FDA Manufacturer Evaluation Result Code Hierarchy	C139504	Packaging Contains Unintended Material	4244	IMDRF:C160503		Problems that occurred because unintended material was packaged with the device.	Problems that occurred because unintended material was packaged with the device.	C92094	Packaging Problem Identified	111
C	FDA	C91801	FDA Manufacturer Evaluation Result Code Hierarchy	C139505	Packaging Materials Problem	4243	IMDRF:C160502		Problems that occurred because of the composition or type of packaging materials was inappropriate for the device.	Problems that occurred because of the composition or type of packaging materials was inappropriate for the device.	C92094	Packaging Problem Identified	111
C	FDA	C91801	FDA Manufacturer Evaluation Result Code Hierarchy	C139506	Alarm System Problem Identified	4221	IMDRF:C1202		A system intended to warn of a potentially unsafe condition did not operate correctly.	A system intended to warn of a potentially unsafe condition did not operate correctly.	C92098	Protective System Problem Identified	3228
C	FDA	C91801	FDA Manufacturer Evaluation Result Code Hierarchy	C139507	Fail-safe Problem Identified	4220	IMDRF:C1201		A system intended to prevent unsafe operation of the device did not operate correctly.	A system intended to prevent unsafe operation of the device did not operate correctly.	C92098	Protective System Problem Identified	3228
C	FDA	C91801	FDA Manufacturer Evaluation Result Code Hierarchy	C139508	Missing or Inadequate Safety Measures	4227	IMDRF:C1208		Safety measures are inadequately applied or missing.	Safety measures are inadequately applied or missing.	C92098	Protective System Problem Identified	3228
C	FDA	C91801	FDA Manufacturer Evaluation Result Code Hierarchy	C139509	Premature Indicator Activation	4224	IMDRF:C1205		A system intended to indicate the device status was triggered prematurely.	A system intended to indicate the device status was triggered prematurely.	C92098	Protective System Problem Identified	3228
C	FDA	C91801	FDA Manufacturer Evaluation Result Code Hierarchy	C139510	Problem of Device to Self-Test	4222	IMDRF:C1203		Malfunction of the device's self-test system.	Malfunction of the device's self-test system.	C92098	Protective System Problem Identified	3228
C	FDA	C91801	FDA Manufacturer Evaluation Result Code Hierarchy	C139511	Problem to Auto Stop	4223	IMDRF:C1204		An auto stop function of a device did not operate correctly.	An auto stop function of a device did not operate correctly.	C92098	Protective System Problem Identified	3228
C	FDA	C91801	FDA Manufacturer Evaluation Result Code Hierarchy	C139512	Reset Problem	4225	IMDRF:C1206		The device does not reset properly.	The device does not reset properly.	C92098	Protective System Problem Identified	3228
C	FDA	C91801	FDA Manufacturer Evaluation Result Code Hierarchy	C139513	Shielding Problem	4226	IMDRF:C1207		Inadequate shielding of/by the device.	Inadequate shielding of/by the device.	C92098	Protective System Problem Identified	3228
C	FDA	C91801	FDA Manufacturer Evaluation Result Code Hierarchy	C139514	Data Storage or Loss of Data	4215	IMDRF:C1009		Storage of data was unsuccessful in total or in part.	Storage of data was unsuccessful in total or in part.	C92113	Software Problem Identified	104
C	FDA	C91801	FDA Manufacturer Evaluation Result Code Hierarchy	C139515	Erroneous Data Transfer	4214	IMDRF:C1008		The device software fails to transfer the expected data within a system or to another device.	The device software fails to transfer the expected data within a system or to another device.	C92113	Software Problem Identified	104
C	FDA	C91801	FDA Manufacturer Evaluation Result Code Hierarchy	C139516	Software Maintenance Problem Identified	4213	IMDRF:C1003		The device software was not maintained/updated properly.	The device software was not maintained/updated properly.	C92113	Software Problem Identified	104
C	FDA	C91801	FDA Manufacturer Evaluation Result Code Hierarchy	C139517	Excessive Cooling Identified	4218	IMDRF:C1103		The device cooled the patient or another device more than intended or expected during operation.	The device cooled the patient or another device more than intended or expected during operation.	C92122	Thermal Problem	642
C	FDA	C91801	FDA Manufacturer Evaluation Result Code Hierarchy	C139518	Excessive Heating Identified	4217	IMDRF:C1102		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.	The device delivered more heat than intended or expected during operation. This applies to devices which are intended to deliver heat.	C92122	Thermal Problem	642
C	FDA	C91801	FDA Manufacturer Evaluation Result Code Hierarchy	C139519	Inadequate Cooling Identified	4219	IMDRF:C1104		The device did not sufficiently cool the patient or another device during operation.	The device did not sufficiently cool the patient or another device during operation.	C92122	Thermal Problem	642
C	FDA	C91801	FDA Manufacturer Evaluation Result Code Hierarchy	C139520	Overheating Problem Identified	4216	IMDRF:C1101		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.	The device was found to become hotter than expected during operation. This applies to devices which are not intended to deliver heat.	C92122	Thermal Problem	642
C	FDA	C91801	FDA Manufacturer Evaluation Result Code Hierarchy	C139521	Change in Target Marker/Variant/ Mutant	4236	IMDRF:C1403		Problem due to change in target marker/variant/mutant which is not covered in the labelling.	Problem due to change in target marker/variant/mutant which is not covered in the labeling.	C139467	Patient Sample Problem	4233
C	FDA	C91801	FDA Manufacturer Evaluation Result Code Hierarchy	C139522	Known Interferent	4235	IMDRF:C1402		Known interferent in the sample identified.	Known interferent in the sample identified.	C139467	Patient Sample Problem	4233
C	FDA	C91801	FDA Manufacturer Evaluation Result Code Hierarchy	C139523	New or Unknown Interferent	4234	IMDRF:C1401		New or unknown endogenous or exogenous interferent (sample) identified.	New or unknown endogenous or exogenous interferent (sample) identified.	C139467	Patient Sample Problem	4233
C	FDA	C91801	FDA Manufacturer Evaluation Result Code Hierarchy	C139524	Pre-analytical Handling Problem	4237	IMDRF:C1404		Incorrect pre-analytical handling of patient's sample by the user.	Incorrect pre-analytical handling of patient's sample by the user.	C139467	Patient Sample Problem	4233
C	FDA	C91802	FDA Manufacturer Evaluation Conclusion Code Hierarchy	C139525	Adverse Event Related to Commutability	4312	IMDRF:D1003		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.	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.	C139470	Cause cannot be Traced to Device	4310
C	FDA	C91802	FDA Manufacturer Evaluation Conclusion Code Hierarchy	C139526	Adverse Event Related to Procedure	4311	IMDRF:D1002		The adverse event occurred during the procedure and the device had no influence on event.	The adverse event occurred during the procedure and the device had no influence on event.	C139470	Cause cannot be Traced to Device	4310
C	FDA	C91801	FDA Manufacturer Evaluation Result Code Hierarchy	C139575	Device Incorrectly Reprocessed	4228	IMDRF:C1301		Problems associated with the failure to properly and adequately reprocess the device.	Problems associated with the failure to properly and adequately reprocess the device.	C92088	Operational Problem Identified	114
C	FDA	C91801	FDA Manufacturer Evaluation Result Code Hierarchy	C139576	Sterilization Problem Identified	4241	IMDRF:C1602		Problems that occurred during terminal sterilization by the manufacturer.	Problems that occurred during terminal sterilization by the manufacturer.	C92076	Manufacturing Process Problem Identified	170
C	FDA	C91802	FDA Manufacturer Evaluation Conclusion Code Hierarchy	C91868	Conclusion Not Yet Available	11	IMDRF:D16		A conclusion has yet to be established as the investigation is incomplete. Do not use this code if the investigation is complete.	A conclusion has yet to be established as the investigation is incomplete.	C91802	FDA Manufacturer Evaluation Conclusion Code Hierarchy	
C	FDA	C91802	FDA Manufacturer Evaluation Conclusion Code Hierarchy	C91869	Cause Traced to Device Design	12	IMDRF:D01		Problems traced to the design specifications (e.g. in the requirements, testing processes, hazard analysis, implementation strategy).	Problems traced to the design specifications (e.g. in the requirements, testing processes, hazard analysis, implementation strategy).	C91802	FDA Manufacturer Evaluation Conclusion Code Hierarchy	
C	FDA	C91801	FDA Manufacturer Evaluation Result Code Hierarchy	C91870	Device Difficult to Operate	13	IMDRF:C1303		Problems including set-up, operation, and disassembly of equipment. Not including reprocessing.	Problems including set-up, operation, and disassembly of equipment. Not including reprocessing.	C92088	Operational Problem Identified	114
C	FDA	C91802	FDA Manufacturer Evaluation Conclusion Code Hierarchy	C91872	Adverse Event Related to Patient Condition	50	IMDRF:D1001		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.	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.	C139470	Cause cannot be Traced to Device	4310
C	FDA	C91802	FDA Manufacturer Evaluation Conclusion Code Hierarchy	C91873	Failure To Follow Instructions	18	IMDRF:D1101		Problems traced to the user not following the manufacturer's instructions.	Problems traced to the user not following the manufacturer's instructions.	C91874	Cause Traced to User	19
C	FDA	C91802	FDA Manufacturer Evaluation Conclusion Code Hierarchy	C91874	Cause Traced to User	19	IMDRF:D11		The adverse event caused partially or wholly by the user of the device including sample handling.	The adverse event was caused partially or wholly by the user of the device including sample handling.	C91802	FDA Manufacturer Evaluation Conclusion Code Hierarchy	
C	FDA	C91802	FDA Manufacturer Evaluation Conclusion Code Hierarchy	C91877	Cause Traced to Infrastructure	21	IMDRF:D05		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).	The undesirable presence of living organisms such as bacteria, fungi, or viruses or their products (enzymes or toxins).	C91802	FDA Manufacturer Evaluation Conclusion Code Hierarchy	
C	FDA	C91802	FDA Manufacturer Evaluation Conclusion Code Hierarchy	C91878	Known Inherent Risk of Device	22	IMDRF:D12		Reported adverse event known and documented in the labeling (including both short or long term known complications or adverse reactions).	Reported adverse event known and documented in the labeling (including both short or long term known complications or adverse reactions).	C91802	FDA Manufacturer Evaluation Conclusion Code Hierarchy	
C	FDA	C91802	FDA Manufacturer Evaluation Conclusion Code Hierarchy	C91879	Cause Traced to Labeling	57	IMDRF:D09		Problems that occur as the result of problems with the labeling (including package inserts, instruction manuals, instructions for use).	Problems that occur as the result of problems with the labeling (including package inserts, instruction manuals, instructions for use).	C91802	FDA Manufacturer Evaluation Conclusion Code Hierarchy	
C	FDA	C91802	FDA Manufacturer Evaluation Conclusion Code Hierarchy	C91880	Cause Traced to Maintenance	51	IMDRF:D07		Problems traced to improper routine or preventative maintenance.	Problems traced to improper routine or preventative maintenance.	C91802	FDA Manufacturer Evaluation Conclusion Code Hierarchy	
C	FDA	C91802	FDA Manufacturer Evaluation Conclusion Code Hierarchy	C91881	Manufacturing Deficiency	23	IMDRF:D0301		Problems traced to manufacturing process.	Problems traced to manufacturing process.	C91885	Cause Traced to Manufacturing	25
C	FDA	C91802	FDA Manufacturer Evaluation Conclusion Code Hierarchy	C91885	Cause Traced to Manufacturing	25	IMDRF:D03		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.	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.	C91802	FDA Manufacturer Evaluation Conclusion Code Hierarchy	
C	FDA	C91802	FDA Manufacturer Evaluation Conclusion Code Hierarchy	C91889	Cause Traced to Training	27	IMDRF:D08		Problems caused by inadequate training.	Problems caused by inadequate training.	C91802	FDA Manufacturer Evaluation Conclusion Code Hierarchy	
C	FDA	C91802	FDA Manufacturer Evaluation Conclusion Code Hierarchy	C91892	Cause Traced to Intentional Off-Label, Unapproved, or Contraindicated Use	24	IMDRF:D1103		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.	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.	C91874	Cause Traced to User	19
C	FDA	C91802	FDA Manufacturer Evaluation Conclusion Code Hierarchy	C91893	Reuse of Single Use Device	26	IMDRF:D1106		Problems traced to the use of the device more than once when it is designed for only one use.	Problems traced to the use of the device more than once when it is designed for only one use.	C91874	Cause Traced to User	19
C	FDA	C91802	FDA Manufacturer Evaluation Conclusion Code Hierarchy	C91894	No Problem Detected	67	IMDRF:D14		The device complaint or problem cannot be confirmed.	The device complaint or problem cannot be confirmed.	C91802	FDA Manufacturer Evaluation Conclusion Code Hierarchy	
C	FDA	C91802	FDA Manufacturer Evaluation Conclusion Code Hierarchy	C91895	Unintended Use Error Caused or Contributed to Event	61	IMDRF:D1102		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.	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.	C91874	Cause Traced to User	19
C	FDA	C91800	FDA Manufacturer Evaluation Method Code Hierarchy	C91896	Testing of Actual/Suspected Device	10	IMDRF:B01		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.	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.	C91800	FDA Manufacturer Evaluation Method Code Hierarchy	
C	FDA	C91800	FDA Manufacturer Evaluation Method Code Hierarchy	C91933	Testing of Device from Same Lot/Batch Retained by Manufacturer	11	IMDRF:B02		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.	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.	C91800	FDA Manufacturer Evaluation Method Code Hierarchy	
C	FDA	C91800	FDA Manufacturer Evaluation Method Code Hierarchy	C91978	Analysis of Production Records	3331	IMDRF:B14		The investigation involved the analysis of relevant production records in view of supporting the identification of possible causes for the adverse event.	The investigation involved the analysis of relevant production records in view of supporting the identification of possible causes for the adverse event.	C91800	FDA Manufacturer Evaluation Method Code Hierarchy	
C	FDA	C91801	FDA Manufacturer Evaluation Result Code Hierarchy	C92026	Agglutination Problem	3202	IMDRF:C010601		The device affects the ability of the blood to clot which may be induced by chemical, mechanical, or thermal properties of the device.	The device affects the ability of the blood to clot which may be induced by chemical, mechanical, or thermal properties of the device.	C92060	Hematological Problem Identified	3255
C	FDA	C91801	FDA Manufacturer Evaluation Result Code Hierarchy	C92028	Assembly Problem Identified	706	IMDRF:C1601		Problems that occurred because the device was assembled incorrectly.	Problems that occurred because the device was assembled incorrectly.	C92076	Manufacturing Process Problem Identified	170
C	FDA	C91801	FDA Manufacturer Evaluation Result Code Hierarchy	C92029	Biocompatibility Problem Identified	3203	IMDRF:C0101		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)	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)	C92030	Biological Problem Identified	3204
C	FDA	C91801	FDA Manufacturer Evaluation Result Code Hierarchy	C92030	Biological Problem Identified	3204	IMDRF:C01		Problems relating to, caused by or affecting biological processes or living organisms.	Problems relating to, caused by or affecting biological processes or living organisms.	C91801	FDA Manufacturer Evaluation Result Code Hierarchy	
C	FDA	C91801	FDA Manufacturer Evaluation Result Code Hierarchy	C92031	Carcinogenic Problem	3205	IMDRF:C010501		The device's ability to trigger development of cancer.	The device's ability to trigger development of cancer.	C92057	Genotoxicity Problem Identified	3254
C	FDA	C91801	FDA Manufacturer Evaluation Result Code Hierarchy	C92034	Communications Problem Identified	628	IMDRF:C0401		Devices that do not send or receive adequate signals (this speaks to the interoperability between devices).	Devices that do not send or receive adequate signals (this speaks to the interoperability between devices).	C92070	Interoperability Problem Identified	3213
C	FDA	C91801	FDA Manufacturer Evaluation Result Code Hierarchy	C92035	Complement Activation Problem	3206	IMDRF:C010602		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.	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.	C92060	Hematological Problem Identified	3255
C	FDA	C91801	FDA Manufacturer Evaluation Result Code Hierarchy	C92036	Device Migration	3207	IMDRF:C0701		A device that has moved from its original location due to external forces (e.g. stent or lead movement).	A device that has moved from its original location due to external forces (e.g. stent or lead movement).	C92079	Mechanical Problem Identified	180
C	FDA	C91801	FDA Manufacturer Evaluation Result Code Hierarchy	C92037	Conducted Interference	658	IMDRF:C0301		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).	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).	C92046	Electromagnetic Compatibility Problem Identified	197
C	FDA	C91801	FDA Manufacturer Evaluation Result Code Hierarchy	C92038	Configuration Issue	3208	IMDRF:C1001		Problems due to change control or incorrect version, including regional requirements.	Problems due to change control or incorrect version, including regional requirements.	C92113	Software Problem Identified	104
C	FDA	C91801	FDA Manufacturer Evaluation Result Code Hierarchy	C92039	Data Compression Error	663	IMDRF:C100201		Data was lost or corrupted during the operation of reducing storage space or communication bandwidth.	Data was lost or corrupted during the operation of reducing storage space or communication bandwidth.	C92042	Design Error	110
C	FDA	C91801	FDA Manufacturer Evaluation Result Code Hierarchy	C92040	Deformation Problem	3211	IMDRF:C070601		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.	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.	C92120	Stress Problem Identified	3243
C	FDA	C91801	FDA Manufacturer Evaluation Result Code Hierarchy	C92041	Degradation Problem Identified	135	IMDRF:C0601		Problems that occur when the device becomes worn, weakened, corroded, or broken down due to processes such as aging, permeation, and corrosion.	Problems that occur when the device becomes worn, weakened, corroded, or broken down due to processes such as aging, permeation, and corrosion.	C92078	Material and/or Chemical Problem Identified	174
C	FDA	C91801	FDA Manufacturer Evaluation Result Code Hierarchy	C92042	Design Error	110	IMDRF:C1002		The device had faulty (incomplete or incorrect) software design.	The device had faulty (incomplete or incorrect) software design.	C92113	Software Problem Identified	104
C	FDA	C91801	FDA Manufacturer Evaluation Result Code Hierarchy	C92043	Dust or Dirt Problem Identified	646	IMDRF:C1502		A device that experienced problems due to ingress, or coating, of dust or dirt.	A device that experienced problems due to ingress, or coating, of dust or dirt.	C92051	Environment Problem Identified	331
C	FDA	C91801	FDA Manufacturer Evaluation Result Code Hierarchy	C92044	Current Leakage Problem	650	IMDRF:C0206		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.	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.	C92045	Electrical Problem Identified	120
C	FDA	C91801	FDA Manufacturer Evaluation Result Code Hierarchy	C92045	Electrical Problem Identified	120	IMDRF:C02		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.	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.	C91801	FDA Manufacturer Evaluation Result Code Hierarchy	
C	FDA	C91801	FDA Manufacturer Evaluation Result Code Hierarchy	C92046	Electromagnetic Compatibility Problem Identified	197	IMDRF:C03		Device-to-device or device-environment problem resulting from electromagnetic disturbances.	Device-to-device or device-environment problem resulting from electromagnetic disturbances.	C91801	FDA Manufacturer Evaluation Result Code Hierarchy	
C	FDA	C91801	FDA Manufacturer Evaluation Result Code Hierarchy	C92047	Electrostatic Discharge	648	IMDRF:C0302		Problems due to sudden and momentary bursts of electrical current flowing between two objects at different electrical potentials.	Problems due to sudden and momentary bursts of electrical current flowing between two objects at different electrical potentials.	C92046	Electromagnetic Compatibility Problem Identified	197
C	FDA	C91802	FDA Manufacturer Evaluation Conclusion Code Hierarchy	C92048	End of Life Problem Identified	133	IMDRF:D1105		Problems traced to the device reaching the end of its useful life.	Problems traced to the device reaching the end of its useful life.	C91874	Cause Traced to User	19
C	FDA	C91801	FDA Manufacturer Evaluation Result Code Hierarchy	C92049	Endotoxin Contamination	3212	IMDRF:C010201		The undesirable presence of toxins associated with certain bacteria (e.g. gram negative bacteria).	The undesirable presence of toxins associated with certain bacteria (e.g. gram negative bacteria).	C92054	Biological Contamination	142
C	FDA	C91801	FDA Manufacturer Evaluation Result Code Hierarchy	C92050	Energy Storage System Problem	131	IMDRF:C020701		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.	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.	C92097	Power Source Problem Identified	3227
C	FDA	C91801	FDA Manufacturer Evaluation Result Code Hierarchy	C92051	Environment Problem Identified	331	IMDRF:C15		Problems that occurred due to factors within the environment e.g. dust, dirt, humidity, temperature.	Problems that occurred due to factors within the environment e.g. dust, dirt, humidity, temperature.	C91801	FDA Manufacturer Evaluation Result Code Hierarchy	
C	FDA	C91801	FDA Manufacturer Evaluation Result Code Hierarchy	C92052	Failure to Calibrate	3250	IMDRF:C1302		A device that cannot calibrate (establish the relationship between a measuring device and the units of measure) to ensure accurate readings.	A device that cannot calibrate (establish the relationship between a measuring device and the units of measure) to ensure accurate readings.	C92088	Operational Problem Identified	114
C	FDA	C91801	FDA Manufacturer Evaluation Result Code Hierarchy	C92053	Fatigue Problem	3251	IMDRF:C070602		Problems due to the weakening or breakdown of its material when subjected to stress or a series of repeated stresses.	Problems due to the weakening or breakdown of its material when subjected to stress or a series of repeated stresses.	C92120	Stress Problem Identified	3243
C	FDA	C91801	FDA Manufacturer Evaluation Result Code Hierarchy	C92054	Biological Contamination	142	IMDRF:C0102		The undesirable presence of living organisms such as bacteria, fungi, or viruses or their products (enzymes or toxins).	The undesirable presence of living organisms such as bacteria, fungi, or viruses or their products (enzymes or toxins).	C92030	Biological Problem Identified	3204
C	FDA	C91801	FDA Manufacturer Evaluation Result Code Hierarchy	C92055	Fracture Problem	3252	IMDRF:C070603		Problems caused by the separation of a component, object, or material into two or more pieces including shear.	Problems caused by the separation of a component, object, or material into two or more pieces including shear.	C92120	Stress Problem Identified	3243
C	FDA	C91801	FDA Manufacturer Evaluation Result Code Hierarchy	C92056	Friction Problem Identified	3253	IMDRF:C0702		Problems caused by its surface coming in contact with another surface or fluid.	Problems caused by its surface coming in contact with another surface or fluid.	C92079	Mechanical Problem Identified	180
C	FDA	C91801	FDA Manufacturer Evaluation Result Code Hierarchy	C92057	Genotoxicity Problem Identified	3254	IMDRF:C0105		The device's ability to cause damage to genetic material (e.g. leading to malignant tumors). (See ISO 10993)	The device's ability to cause damage to genetic material (e.g. leading to malignant tumors).	C92030	Biological Problem Identified	3204
C	FDA	C91801	FDA Manufacturer Evaluation Result Code Hierarchy	C92058	Gradient Induced Field Problem	323	IMDRF:C0901		Problems that result from the gradient-induced fields generated during radiologic procedures e.g. magnetic resonance imaging.	Problems that result from the gradient-induced fields generated during radiologic procedures e.g. magnetic resonance imaging.	C92102	Clinical Imaging Problem Identified	3230
C	FDA	C91801	FDA Manufacturer Evaluation Result Code Hierarchy	C92059	Hardware Timing Problem Identified	211	IMDRF:C0202		Problems that results from improper sequential activation of components.	Problems that results from improper sequential activation of components.	C92045	Electrical Problem Identified	120
C	FDA	C91801	FDA Manufacturer Evaluation Result Code Hierarchy	C92060	Hematological Problem Identified	3255	IMDRF:C0106		The device affects or impacts the blood or its components. (See ISO 10993 all parts)	The device affects or impacts the blood or its components. (See ISO 10993 all parts)	C92030	Biological Problem Identified	3204
C	FDA	C91801	FDA Manufacturer Evaluation Result Code Hierarchy	C92061	Environmental Humidity Problem Identified	332	IMDRF:C1506		Device performance was affected by the humidity, or changes in humidity, of the environment in which it was used.	Device performance was affected by the humidity, or changes in humidity, of the environment in which it was used.	C92051	Environment Problem Identified	331
C	FDA	C91801	FDA Manufacturer Evaluation Result Code Hierarchy	C92062	Image Artifact	3256	IMDRF:C0902		The unacceptable distortion of an image due to signal loss that may occur during a radiologic procedure such as magnetic resonance imaging.	The unacceptable distortion of an image due to signal loss that may occur during a radiologic procedure such as magnetic resonance imaging.	C92102	Clinical Imaging Problem Identified	3230
C	FDA	C91801	FDA Manufacturer Evaluation Result Code Hierarchy	C92063	Impedance Problem Identified	3257	IMDRF:C0203		Problems due to insufficient or excessive resistance to current flow either by the device or circuit.	Problems due to insufficient or excessive resistance to current flow either by the device or circuit.	C92045	Electrical Problem Identified	120
C	FDA	C91801	FDA Manufacturer Evaluation Result Code Hierarchy	C92064	Improper Composition/ Concentration	3258	IMDRF:C060201		Problems associated with the improper combination of materials or elements present in the device (e.g. improper composition of the materials of a capacitor).	Problems associated with the improper combination of materials or elements present in the device (e.g. improper composition of the materials of a capacitor).	C92065	Inappropriate Material	202
C	FDA	C91801	FDA Manufacturer Evaluation Result Code Hierarchy	C92065	Inappropriate Material	202	IMDRF:C0602		Problems that occur due to the presence of a material that should not be present or part of the device.	Problems that occur due to the presence of a material that should not be present or part of the device.	C92078	Material and/or Chemical Problem Identified	174
C	FDA	C91801	FDA Manufacturer Evaluation Result Code Hierarchy	C92066	Incompatible Component/ Accessory	102	IMDRF:C0402		A device that malfunctions due to a component(s)/accessory that does not operate correctly and according to the device's specifications.	A device that malfunctions due to a component(s)/accessory that does not operate correctly and according to the device's specifications.	C92070	Interoperability Problem Identified	3213
C	FDA	C91801	FDA Manufacturer Evaluation Result Code Hierarchy	C92067	Installation Problem Identified	3201	IMDRF:C1603		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).	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).	C92076	Manufacturing Process Problem Identified	170
C	FDA	C91801	FDA Manufacturer Evaluation Result Code Hierarchy	C92068	Insulation Problem Identified	144	IMDRF:C0204		Problems due to inadequate or incorrect electrical insulation material.	Problems due to inadequate or incorrect electrical insulation material.	C92045	Electrical Problem Identified	120
C	FDA	C91801	FDA Manufacturer Evaluation Result Code Hierarchy	C92069	Interface Design Error	113	IMDRF:C100204		The device software was found to contain errors in the user interface (including usability problems) or the interfaces with other systems.	The device software was found to contain errors in the user interface (including usability problems) or the interfaces with other systems.	C92042	Design Error	110
C	FDA	C91801	FDA Manufacturer Evaluation Result Code Hierarchy	C92070	Interoperability Problem Identified	3213	IMDRF:C04		Problems with the mechanical, electrical, or communication interface between two or more separate devices.	Problems with the mechanical, electrical, or communication interface between two or more separate devices.	C91801	FDA Manufacturer Evaluation Result Code Hierarchy	
C	FDA	C91801	FDA Manufacturer Evaluation Result Code Hierarchy	C92071	Labeling and Instructions for Use/Maintenance	150	IMDRF:C05		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.	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.	C91801	FDA Manufacturer Evaluation Result Code Hierarchy	
C	FDA	C91801	FDA Manufacturer Evaluation Result Code Hierarchy	C92072	Loss of Power	610	IMDRF:C020702		A device that experienced problems due to a loss in the power supply.	A device that experienced problems due to a loss in the power supply.	C92097	Power Source Problem Identified	3227
C	FDA	C91801	FDA Manufacturer Evaluation Result Code Hierarchy	C92073	Lubrication Problem Identified	145	IMDRF:C0704		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).	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).	C92079	Mechanical Problem Identified	180
C	FDA	C91801	FDA Manufacturer Evaluation Result Code Hierarchy	C92074	Magnetically-Induced Movement	3215	IMDRF:C0903		Problems due to unintended or excessive movement created by the application of magnetic fields.	Problems due to unintended or excessive movement created by the application of magnetic fields.	C92102	Clinical Imaging Problem Identified	3230
C	FDA	C91801	FDA Manufacturer Evaluation Result Code Hierarchy	C92075	Maintenance Problem Identified	115	IMDRF:C17		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).	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).	C91801	FDA Manufacturer Evaluation Result Code Hierarchy	
C	FDA	C91801	FDA Manufacturer Evaluation Result Code Hierarchy	C92076	Manufacturing Process Problem Identified	170	IMDRF:C16		Problems with a device that can be traced to a problem in the manufacturing and/or production process.	Problems with a device that can be traced to a problem in the manufacturing and/or production process.	C91801	FDA Manufacturer Evaluation Result Code Hierarchy	
C	FDA	C91801	FDA Manufacturer Evaluation Result Code Hierarchy	C92077	Material or Material Leachate Pyrogenic Problem	3216	IMDRF:C0103		The undesirable presence of pyrogens or fever-producing organisms caused by materials that permeate through the device.	The undesirable presence of pyrogens or fever-producing organisms caused by materials that permeate through the device.	C92030	Biological Problem Identified	3204
C	FDA	C91801	FDA Manufacturer Evaluation Result Code Hierarchy	C92078	Material and/or Chemical Problem Identified	174	IMDRF:C06		Problems with the device materials or how its materials react to other elements either within the device or within the environment.	Problems with the device materials or how its materials react to other elements either within the device or within the environment.	C91801	FDA Manufacturer Evaluation Result Code Hierarchy	
C	FDA	C91801	FDA Manufacturer Evaluation Result Code Hierarchy	C92079	Mechanical Problem Identified	180	IMDRF:C07		Problems that result from internal or external forces including fluids, other objects, or environmental or physiologic influences.	Problems that result from internal or external forces including fluids, other objects, or environmental or physiologic influences.	C91801	FDA Manufacturer Evaluation Result Code Hierarchy	
C	FDA	C91801	FDA Manufacturer Evaluation Result Code Hierarchy	C92080	Mechanical Shock Problem	3217	IMDRF:C070604		Problems caused by the sudden violent blow or collision to the whole device (e.g. by dropping).	Problems caused by the sudden violent blow or collision to the whole device (e.g. by dropping).	C92120	Stress Problem Identified	3243
C	FDA	C91801	FDA Manufacturer Evaluation Result Code Hierarchy	C92081	Microbial Contamination	3218	IMDRF:C010202		The undesirable presence of microorganisms or microbes such as bacteria and fungi (yeasts and molds).	The undesirable presence of microorganisms or microbes such as bacteria and fungi (yeasts and molds).	C92054	Biological Contamination	142
C	FDA	C91801	FDA Manufacturer Evaluation Result Code Hierarchy	C92082	Mutagenic Problem	3220	IMDRF:C010502		The device's ability to change genetic information (usually DNA) of an organism and thus increasing the frequency of mutations.	The device's ability to change genetic information (usually DNA) of an organism and thus increasing the frequency of mutations.	C92057	Genotoxicity Problem Identified	3254
C	FDA	C91801	FDA Manufacturer Evaluation Result Code Hierarchy	C92083	No Device Problem Found	213	IMDRF:C19		The device either functioned as intended or a problem was not found.	The device either functioned as intended or a problem was not found.	C91801	FDA Manufacturer Evaluation Result Code Hierarchy	
C	FDA	C91801	FDA Manufacturer Evaluation Result Code Hierarchy	C92084	No Findings Available	3221	IMDRF:C20		Use when no investigation can be performed and therefore no results will be obtained.	Use when no investigation can be performed and therefore no results will be obtained.	C91801	FDA Manufacturer Evaluation Result Code Hierarchy	
C	FDA	C91801	FDA Manufacturer Evaluation Result Code Hierarchy	C92085	Non-Functional Defect	3222	IMDRF:C100205		The device software contained software errors that did not impact its operation.	The device software contained software errors that did not impact its operation.	C92042	Design Error	110
C	FDA	C91801	FDA Manufacturer Evaluation Result Code Hierarchy	C92087	Open Circuit	122	IMDRF:C0205		Problem due to an electrical circuit that does not conduct current because a switch is open, a wire is broken, etc.	Problem due to an electrical circuit that does not conduct current because a switch is open, a wire is broken, etc.	C92045	Electrical Problem Identified	120
C	FDA	C91801	FDA Manufacturer Evaluation Result Code Hierarchy	C92088	Operational Problem Identified	114	IMDRF:C13		Problems that occur during the performance, use, or functioning of the device.	Problems that occur during the performance, use, or functioning of the device.	C91801	FDA Manufacturer Evaluation Result Code Hierarchy	
C	FDA	C91801	FDA Manufacturer Evaluation Result Code Hierarchy	C92089	Optical Problem Identified	3224	IMDRF:C08		Problems related to the optical properties of a device.	Problems related to the optical properties of a device.	C91801	FDA Manufacturer Evaluation Result Code Hierarchy	
C	FDA	C91801	FDA Manufacturer Evaluation Result Code Hierarchy	C92090	Optical Transmission Problem Identified	196	IMDRF:C0801		Problems with the device's ability to pass light energy.	Problems with the device's ability to pass light energy.	C92089	Optical Problem Identified	3224
C	FDA	C91801	FDA Manufacturer Evaluation Result Code Hierarchy	C92093	Packaging Compromised	171	IMDRF:C160501		Problems that occurred because of a compromised packaging of the device (e.g. broken or incomplete seal).	Problems that occurred because of a compromised packaging of the device (e.g. broken or incomplete seal).	C92094	Packaging Problem Identified	111
C	FDA	C91801	FDA Manufacturer Evaluation Result Code Hierarchy	C92094	Packaging Problem Identified	111	IMDRF:C1605		Problems that occurred because of the device packaging.	Problems that occurred because of the device packaging.	C92076	Manufacturing Process Problem Identified	170
C	FDA	C91801	FDA Manufacturer Evaluation Result Code Hierarchy	C92095	Platelet Activation Problem	3226	IMDRF:C010603		The device affects the body's ability to activate platelet formation.	The device affects the body's ability to activate platelet formation.	C92060	Hematological Problem Identified	3255
C	FDA	C91801	FDA Manufacturer Evaluation Result Code Hierarchy	C92096	Power Fluctuation	659	IMDRF:C020703		The device failed due to fluctuations within the power supply (e.g. transient power, power spike, power dip, or power sequencing).	The device failed due to fluctuations within the power supply (e.g. transient power, power spike, power dip, or power sequencing).	C92097	Power Source Problem Identified	3227
C	FDA	C91801	FDA Manufacturer Evaluation Result Code Hierarchy	C92097	Power Source Problem Identified	3227	IMDRF:C0207		Problems related to the source that provides electrical power to the device.	Problems related to the source that provides electrical power to the device.	C92045	Electrical Problem Identified	120
C	FDA	C91801	FDA Manufacturer Evaluation Result Code Hierarchy	C92098	Protective System Problem Identified	3228	IMDRF:C12		Problems related to the system(s) designed to prevent or warn about unsafe operation of the device.	Problems related to the system(s) designed to prevent or warn about unsafe operation of the device.	C91801	FDA Manufacturer Evaluation Result Code Hierarchy	
C	FDA	C91802	FDA Manufacturer Evaluation Conclusion Code Hierarchy	C92099	Quality Control Deficiency	143	IMDRF:D0302		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.	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.	C91885	Cause Traced to Manufacturing	25
C	FDA	C91801	FDA Manufacturer Evaluation Result Code Hierarchy	C92100	Radiofrequency Induced Overheating	3229	IMDRF:C0904		Problems due to unintended radiofrequency-induced temperature increase that can occur in the vicinity of the device.	Problems due to unintended radiofrequency-induced temperature increase that can occur in the vicinity of the device.	C92102	Clinical Imaging Problem Identified	3230
C	FDA	C91801	FDA Manufacturer Evaluation Result Code Hierarchy	C92101	Radiofrequency Interference (RFI)	611	IMDRF:C0305		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.	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.	C92046	Electromagnetic Compatibility Problem Identified	197
C	FDA	C91801	FDA Manufacturer Evaluation Result Code Hierarchy	C92102	Clinical Imaging Problem Identified	3230	IMDRF:C09		Problems that occur with devices used for radiographic or imaging procedures e.g. CT scanners, magnetic resonance imaging.	Problems that occur with devices used for radiographic or imaging procedures e.g. CT scanners, magnetic resonance imaging.	C91801	FDA Manufacturer Evaluation Result Code Hierarchy	
C	FDA	C91801	FDA Manufacturer Evaluation Result Code Hierarchy	C92103	Reactivity Problem Identified	3231	IMDRF:C0605		Problems that occur due to the reactivity of materials (e.g. over-react or under-react).	Problems that occur due to the reactivity of materials (e.g. over-react or under-react).	C92078	Material and/or Chemical Problem Identified	174
C	FDA	C91801	FDA Manufacturer Evaluation Result Code Hierarchy	C92104	Reproductive Toxicity Problem Identified	3232	IMDRF:C0108		The device affects reproductive function, embryo development (teratogenicity), and prenatal and early postnatal development. (ISO 10993 part 3)	The device affects reproductive function, embryo development (teratogenicity), and prenatal and early postnatal development. (ISO 10993 part 3)	C92030	Biological Problem Identified	3204
C	FDA	C91802	FDA Manufacturer Evaluation Conclusion Code Hierarchy	C92106	Shelf Life/Expiration Date Exceeded	192	IMDRF:D1104		A device that has exceeded the period of time/date recommended by the manufacturer for storing the device without a degradation in quality.	A device that has exceeded the period of time/date recommended by the manufacturer for storing the device without a degradation in quality.	C91874	Cause Traced to User	19
C	FDA	C91801	FDA Manufacturer Evaluation Result Code Hierarchy	C92107	Transport Problem Identified	3236	IMDRF:C1801		Problems traced to how the device was transported e.g. temperature of shipping compartment or method of transportation.	Problems traced to how the device was transported e.g. temperature of shipping compartment or method of transportation.	C139468	Transport/Storage Problem Identified	4246
C	FDA	C91801	FDA Manufacturer Evaluation Result Code Hierarchy	C92108	Short Circuit	121	IMDRF:C0208		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.	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.	C92045	Electrical Problem Identified	120
C	FDA	C91801	FDA Manufacturer Evaluation Result Code Hierarchy	C92109	Signal Loss	3237	IMDRF:C0209		Problems due to the loss or weakening of an electrical signal or signals.	Problems due to the loss or weakening of an electrical signal or signals.	C92045	Electrical Problem Identified	120
C	FDA	C91801	FDA Manufacturer Evaluation Result Code Hierarchy	C92111	Software Installation Problem Identified	3238	IMDRF:C1004		The device software was not installed as per the specifications or failed to properly install.	The device software was not installed as per the specifications or failed to properly install.	C92113	Software Problem Identified	104
C	FDA	C91801	FDA Manufacturer Evaluation Result Code Hierarchy	C92113	Software Problem Identified	104	IMDRF:C10		Problems related to the device software.	Problems related to the device software.	C91801	FDA Manufacturer Evaluation Result Code Hierarchy	
C	FDA	C91801	FDA Manufacturer Evaluation Result Code Hierarchy	C92114	Software Requirement Error	3239	IMDRF:C1005		The software requirements for the device are either incomplete, inadequate, or in conflict.	The software requirements for the device are either incomplete, inadequate, or in conflict.	C92113	Software Problem Identified	104
C	FDA	C91801	FDA Manufacturer Evaluation Result Code Hierarchy	C92115	Software Runtime Error	3240	IMDRF:C1006		The device software failed during operation as a result of a coding error.	The device software failed during operation as a result of a coding error.	C92113	Software Problem Identified	104
C	FDA	C91801	FDA Manufacturer Evaluation Result Code Hierarchy	C92116	Software Security Vulnerability	3241	IMDRF:C1007		The device software failed to provide adequate authorization, access control, protection and accountability features.	The device software failed to provide adequate authorization, access control, protection and accountability features.	C92113	Software Problem Identified	104
C	FDA	C91801	FDA Manufacturer Evaluation Result Code Hierarchy	C92117	Software Timing Problem	634	IMDRF:C100206		Problems that results from the incorrect sequencing or activation of software modules.	Problems that results from the incorrect sequencing or activation of software modules.	C92042	Design Error	110
C	FDA	C91801	FDA Manufacturer Evaluation Result Code Hierarchy	C92118	Stiffness Problem Identified	3242	IMDRF:C0705		Problems that occurred when its material is either too flexible/pliable or inflexible/rigid when in contact by an applied force.	Problems that occurred when its material is either too flexible/pliable or inflexible/rigid when in contact by an applied force.	C92079	Mechanical Problem Identified	180
C	FDA	C91801	FDA Manufacturer Evaluation Result Code Hierarchy	C92119	Storage Problem Identified	193	IMDRF:C1802		Problems that result from storing the device in an uncontrolled or improper environment (e.g. moisture sensitive devices stored in a humid environment).	Problems that result from storing the device in an uncontrolled or improper environment (e.g. moisture sensitive devices stored in a humid environment).	C139468	Transport/Storage Problem Identified	4246
C	FDA	C91801	FDA Manufacturer Evaluation Result Code Hierarchy	C92120	Stress Problem Identified	3243	IMDRF:C0706		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.	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.	C92079	Mechanical Problem Identified	180
C	FDA	C91801	FDA Manufacturer Evaluation Result Code Hierarchy	C92121	Molecular Structure Problem	3219	IMDRF:C060203		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).	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).	C92065	Inappropriate Material	202
C	FDA	C91801	FDA Manufacturer Evaluation Result Code Hierarchy	C92122	Thermal Problem	642	IMDRF:C11		Problems related to the temperature of the device. Note: For problems related to environmental temperature use ''Environment Problem Identified''.	Problems related to the temperature of the device.	C91801	FDA Manufacturer Evaluation Result Code Hierarchy	
C	FDA	C91801	FDA Manufacturer Evaluation Result Code Hierarchy	C92123	Problem due to Thrombosis Activation	3244	IMDRF:C010604		The device causes the formation of blood clots in or along blood vessels resulting in disturbed or disrupted blood flow.	The device causes the formation of blood clots in or along blood vessels resulting in disturbed or disrupted blood flow.	C92060	Hematological Problem Identified	3255
C	FDA	C91801	FDA Manufacturer Evaluation Result Code Hierarchy	C92124	Tolerance Stack-Up	176	IMDRF:C0606		Problems that result from a combination of specification variances of the components.	Problems that result from a combination of specification variances of the components.	C92078	Material and/or Chemical Problem Identified	174
C	FDA	C91801	FDA Manufacturer Evaluation Result Code Hierarchy	C92129	Vibration Problem	649	IMDRF:C070605		Problems caused by the constant rhythmic motion of the device, or something in the environment to which the device is exposed.	Problems that result from a combination of specification variances of the components.	C92120	Stress Problem Identified	3243
C	FDA	C91801	FDA Manufacturer Evaluation Result Code Hierarchy	C92130	Wear Problem	140	IMDRF:C070606		Problems due to the premature or expected erosion of its material by use, deterioration, or change.	Problems due to the premature or expected erosion of its material by use, deterioration, or change.	C92120	Stress Problem Identified	3243
C	FDA	C91801	FDA Manufacturer Evaluation Result Code Hierarchy	C92131	Wired Communication Problem	608	IMDRF:C040101		Communications problems between devices within a wired system.	Communications problems between devices within a wired system.	C92034	Communications Problem Identified	628
C	FDA	C91801	FDA Manufacturer Evaluation Result Code Hierarchy	C92132	Wireless Communication Problem	3248	IMDRF:C040102		Communications problems between devices within a wireless system.	Communications problems between devices within a wireless system.	C92034	Communications Problem Identified	628
C	FDA	C91801	FDA Manufacturer Evaluation Result Code Hierarchy	C92133	Improper Physical Structure	3259	IMDRF:C060202		Problems related to the incorrect or inadequate arrangement of the parts, components, elements, or materials.	Problems related to the incorrect or inadequate arrangement of the parts, components, elements, or materials.	C92065	Inappropriate Material	202
C	FDA	C91801	FDA Manufacturer Evaluation Result Code Hierarchy	C92134	Environmental Temperature Problem Identified	651	IMDRF:C1501		Device performance was affected by the temperature, or changes in temperature, of the environment in which it was used.	Device performance was affected by the temperature, or changes in temperature, of the environment in which it was used.	C92051	Environment Problem Identified	331
C	FDA	C91801	FDA Manufacturer Evaluation Result Code Hierarchy	C92135	Inadequate Immunity	3260	IMDRF:C0303		Problems related to immunity or capabilities to resist electromagnetic interference (EMI).	Problems related to immunity or capabilities to resist electromagnetic interference (EMI).	C92046	Electromagnetic Compatibility Problem Identified	197
C	FDA	C91801	FDA Manufacturer Evaluation Result Code Hierarchy	C92136	Incorrect Labeling and/or Instructions for Use	156	IMDRF:C0502		Missing, incorrect, or inappropriate information on the labels e.g. mislabeled contents or device labeling characteristics or package contents.	Missing, incorrect, or inappropriate information on the labels e.g. mislabeled contents or device labeling characteristics or package contents	C92071	Labeling and Instructions for Use/Maintenance	150
C	FDA	C91801	FDA Manufacturer Evaluation Result Code Hierarchy	C92137	Inadequate Labelling and/or Instructions for Use	154	IMDRF:C0501		Inadequate information on the labels or in the instructions for use e.g. steps that are difficult to follow or that are missing.	Inadequate information on the labels or in the instructions for use e.g. steps that are difficult to follow or that are missing.	C92071	Labeling and Instructions for Use/Maintenance	150
C	FDA	C91801	FDA Manufacturer Evaluation Result Code Hierarchy	C92139	Incompatible Material	203	IMDRF:C0604		Problems that occur due to the incompatibility of materials that co-exist simultaneously as part of the device.	Problems that occur due to the incompatibility of materials that co-exist simultaneously as part of the device.	C92078	Material and/or Chemical Problem Identified	174
C	FDA	C91801	FDA Manufacturer Evaluation Result Code Hierarchy	C92141	Incorrect Data Definition	3200	IMDRF:C100203		The device software was found to contain errors in specifying or manipulating data items.	The device software was found to contain errors in specifying or manipulating data items.	C92042	Design Error	110
C	FDA	C91801	FDA Manufacturer Evaluation Result Code Hierarchy	C92142	Incorrect Algorithm	618	IMDRF:C100202		The device software was found to implement an incorrect sequence of steps for a specific computation.	The device software was found to implement an incorrect sequence of steps for a specific computation.	C92042	Design Error	110
C	FDA	C91801	FDA Manufacturer Evaluation Result Code Hierarchy	C92143	Results Pending Completion of Investigation	3233	IMDRF:C21		Investigation is ongoing and results are not yet available. Do not use this code if the investigation is complete.	Investigation is ongoing and results are not yet available. Do not use this code if the investigation is complete.	C91801	FDA Manufacturer Evaluation Result Code Hierarchy