D 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 D 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 D 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 D 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 D 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 D 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:G03008 D 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:G04077 A C91800 CDRH Cause Investigation - Type of Investigation Terminology C177428 Specimen Requested But Not Provided A patient specimen was required to adequately investigate the issue and was requested but not provided. Specimen Requested But Not Provided 4120 A patient specimen was required to adequately investigate the issue and was requested but not provided. IMDRF:B23 A C91801 CDRH Cause Investigation - Investigation Findings Terminology C177429 Usage Problem Identified Problems that occured related to the actions of a healthcare professional, patient, or other device user. Usage Problem Identified 4248 Problems that occurred related to the actions of a healthcare professional, patient, or other device user. IMDRF:C23 A C91802 CDRH Cause Investigation - Investigation Conclusion Terminology C177431 Inadequate Cybersecurity Problems traced to inadequate protection of computers, servers, mobile devices, electronic systems, networks, programs, and data from malicious attacks, damage, or unauthorized access. Inadequate Cybersecurity 4317 Problems traced to inadequate protection of computers, servers, mobile devices, electronic systems, networks, programs, and data from malicious attacks, damage, or unauthorized access. IMDRF:D0107 A C91802 CDRH Cause Investigation - Investigation Conclusion Terminology C177433 Inadequate Software Design Cause traced to inadequate or inappropriate design of the software component of a medical device, or software as a medical device. Inadequate Software Design. 4318 Cause traced to inadequate or inappropriate design of the software component of a medical device, or Software as a Medical Device. IMDRF:D0108 A C91802 CDRH Cause Investigation - Investigation Conclusion Terminology C177435 Cause Linked to Device, No Further Information Problems traced to the device, but the investigation could not identify the actual root cause (e.g. Design, Manufacturing, Component). Cause linked to device but unable to trace more specifically. 44 Problems traced to the device, but the investigation could not identify the actual root cause (e.g. Design, Manufacturing, Component). IMDRF:D1501 A 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 A 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 A C91802 CDRH Cause Investigation - Investigation Conclusion Terminology C177436 Cause Traced to Software Coding Problems traced to an error, flaw or fault in a computer program or system that causes it to produce an incorrect or unexpected result, or to behave in unintended ways. Cause Traced to Software Coding 58 Problems traced to an error, flaw or fault in a computer program or system that causes it to produce an incorrect or unexpected result, or to behave in unintended ways. IMDRF:D18 A 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 A C54450 CDRH Health Effect - Clinical Code Terminology C177438 Bone Cement Implantation Syndrome A rare and potentially fatal perioperative complication of cemented bone surgery, characterized by hypotension, hypoxia, cardiac dysrhythmias, and in severe cases cardiac arrest. Bone Cement Implantation Syndrome 4583 A rare and potentially fatal perioperative complication of cemented bone surgery, characterised by hypotension, hypoxia, cardiac dysrhythmias, and in severe cases cardiac arrest. IMDRF:E2120 A C54450 CDRH Health Effect - Clinical Code Terminology C75568 Multiple Organ Failure Complete impairment of two or more organs or organ systems. Multiple Organ Dysfunction Syndrome 3261 Complete impairment of two or more organs or organ systems. Also known as multiple organ failure. IMDRF:E2342 A C54577 CDRH Component Code Terminology C54020 Jaw Device A device designed to use opposing parts to close on and hold an object. Jaw 1028 A component designed to use opposing parts to close on and hold an object. IMDRF:G04077 C 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 C 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 C C54451 CDRH Medical Device Problem Code Terminology C62848 Incorrect, Inadequate or Imprecise Result or Readings Problem associated with a nonconforming end result, data, or test results provided by the device to its performance specifications. Incorrect, Inadequate or Imprecise Result or Readings 1535 Problem associated with a nonconforming end result, data, or test results provided by the device to its performance specifications. IMDRF:A0908 C C54451 CDRH Medical Device Problem Code Terminology C63013 Activation, Positioning or Separation Problem Problem associated with any deviations from the documented specifications of a medical device that relate to the sequence of events for activation, positioning or separation of device. Activation, Positioning or Separation Problem 2906 Problem associated with any deviations from the documented specifications of the device that relate to the sequence of events for activation, positioning or separation of device. Note: Deployment is synonymous with activation. IMDRF:A15 C 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 C 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 C 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 C 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 C C91802 CDRH Cause Investigation - Investigation Conclusion Terminology C139470 Cause Cannot be Traced to Device The adverse event that occurred is not attributable to a device. Caused traced to non-device related factors 4310 The adverse event that occurred is confirmed to have been caused by something other than the device or usage. IMDRF:D10 C C54450 CDRH Health Effect - Clinical Code Terminology C50803 Ventriculomeglia Abnormal enlargement of the cerebral ventricles. Cerebral Ventriculomegaly 2133 Abnormal enlargement of the cerebral ventricles. IMDRF:E0105 C 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 C C54450 CDRH Health Effect - Clinical Code Terminology C172050 Unspecified Mental, Emotional or Behavioral Problem An unspecified mental, emotional or behavioral problem. Unspecified Mental, Emotional or Behavioural Problem 4430 The report describes a non-specific Mental, Emotional or Behavioural problem. Note: Please use "Appropriate Term / Code Not Available" if the report describes a specific problem but the relevant term does not exist. IMDRF:E0206 C 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 C 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 C 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 C 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 C 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 C 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 C C54450 CDRH Health Effect - Clinical Code Terminology C50450 Acanthamoeba Keratitis Keratitis due to infection by acanthamoeba; it is usually associated with soft contact lens wear, particularly overnight wear. Acanthamoeba Keratitis 1945 Keratitis due to infection by acanthamoeba. IMDRF:E082901 C 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 C 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 C 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 C C54450 CDRH Health Effect - Clinical Code Terminology C50529 Delayed Union Fracture A bone fracture that is taking an abnormally long time to heal. Nonunion Bone Fracture 2369 Broken bone that doesn't heal. IMDRF:E1625 C 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 C 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 C C54450 CDRH Health Effect - Clinical Code Terminology C9292 Solid Neoplasm A benign or malignant neoplasm arising from tissues that do not include fluid areas. Representative examples include epithelial neoplasms (e.g. lung carcinoma, prostate carcinoma, breast carcinoma, colon carcinoma), and neoplasms arising from the soft tissues and bones (e.g. leiomyosarcoma, liposarcoma, chondrosarcoma, osteosarcoma). Neoplasms originating from the blood or bone marrow (leukemias and myeloproliferative disorders) are not considered solid tumors. Solid Tumour 4552 Abnormal mass of tissue that usually does not contain cysts or liquid areas. Solid tumours may be benign (not cancerous), or malignant (cancerous). Different types of solid tumours are named for the type of cells that form them. If tumours are associated with those under the term cancer, these terms should be used. IMDRF:E1804 C C54450 CDRH Health Effect - Clinical Code Terminology C51220 Insufficient Anesthesia A state of consciousness that permits the formation of explicit and implicit memories while under general anesthesia. Awareness during Anaesthesia 1707 A state of consciousness that permits the formation of explicit and implicit memories while under general anesthesia. IMDRF:E2102 C 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 C 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 C 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 C 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 C C54450 CDRH Health Effect - Clinical Code Terminology C172078 Appropriate Clinical Signs, Symptoms, Conditions Term/Code Not Available The clinical signs, symptoms and conditions are not adequately described by any other term. Appropriate Term / Code Not Available 4581 The clinical signs, symptoms and conditions are not adequately described by any other term. Note: this code must not be used unless there is no other feasible code. The preferred term should be documented when submitting an adverse event report. This information will be used to determine if a new term should be added to the code table. IMDRF:E2402 C 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 C 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 C 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 C 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 C C171094 CDRH Health Effect - Impact Code Terminology C172025 Recognized Device or Procedural Complication Patient experiencing a complication that is well documented in association with the device or procedure. Recognised Device or Procedural Complication 4621 Patient experiencing a complication that is well documented in association with the device or procedure. IMDRF:F15 C C171094 CDRH Health Effect - Impact Code Terminology C171944 Appropriate Health Impact Term/Code Not Available There is no appropriate Health Impact term or code. Appropriate Term/Code Not Available 4650 The Health Impact is not adequately described by any other term. Note: this code must not be used unless there is no other feasible code. The preferred term should be documented when submitting an adverse event report. This information will be used to determine if a new term should be added to the code table. IMDRF:F28 C C54577 CDRH Component Code Terminology C49904 Cusp Device A device consisting of flexible biocompatible membranes, implantable in the cardio-vascular system, designed to prevent retrograde flow of blood but not impede a forward flow. Cusp/Leaflet 439 A thin blade-like component, typically used as part of a one-way valve. IMDRF:G04040 C C54577 CDRH Component Code Terminology C172796 Fabric Cloth produced from textile fibers. Fabric 4770 Cloth produced from textile fibers. IMDRF:G04050 C C54577 CDRH Component Code Terminology C171943 Appropriate Component Term/Code Not Available The parts, components, or sub-assemblies are not adequately described by any other term. Appropriate Term/Code Not Available 4756 The parts, components, or sub-assemblies are not adequately described by any other term. Note: this code must not be used unless there is no other feasible code. The preferred term should be documented when submitting an adverse event report. This information will be used to determine if a new term should be added to the code table. IMDRF:G07002 C C171094 CDRH Health Effect - Impact Code Terminology C52354 Radiation Underdose An inadequate amount of a radiation treatment. Radiation Underdose 2166 A lower than intended dose of radiation to a single field. IMDRF:F100401 C C171094 CDRH Health Effect - Impact Code Terminology C50862 Radiation Overdose A higher than intended cumulative dose of radiation to a single field. Radiation Overdose 1510 A higher than intended cumulative dose of radiation to a single field. IMDRF:F100501 C C54451 CDRH Medical Device Problem Code Terminology C63064 Intermittent Shock Problem associated with the failure to deliver shock for a limited period of time, following which the item recovers its ability to perform its required function without being subjected to any external corrective action. Note: such as failure is often recurrent. Intermittent Shock/Stimulation 2287 Problem associated with the failure to deliver electrical energy for a limited period of time, following which the item recovers its ability to perform its required function without being subjected to any external corrective action. Note: such a failure is often recurrent. IMDRF:A071303 C 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 C 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 C 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 C 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 C C54451 CDRH Medical Device Problem Code Terminology C63067 Intermittent Infusion Problem associated with the infusion not being steady, characterized by intermittent stoppages to the flow. Intermittent Infusion 2341 Problem associated with the infusion not being stead- characterised by intermittent stoppages to the flow. IMDRF:A140506 C C54451 CDRH Medical Device Problem Code Terminology C63019 Device Contaminated during Manufacturing or Shipping Problem associated with the presence of any unexpected foreign substance found on the surface or in the package materials, which may affect optimal performance for its intended use. Device Contaminated During Manufacture or Shipping 2969 Problem associated with the presence of any unexpected foreign substance found on the surface or in the package materials, which may affect optimal performance for its intended use, and which occurred during manufacture or shipping. IMDRF:A1802 C 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. || 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 C C91800 CDRH Cause Investigation - Type of Investigation Terminology C139459 Device Not Manufactured by Reporting Manufacturer Further information was obtained which established that the manufacturer of the device involved was not the one to which it was initially attributed. Device Not Manufactured by Reporting Manufacturer 4113 Further information was obtained which established that the manufacturer of the device involved was not the one to which it was initially attributed. Use in conjunction with C20 and D14. IMDRF:B16 C C91801 CDRH Cause Investigation - Investigation Findings Terminology C92083 No Device Problem Found The device either functioned as intended or a problem was not found. No Device Problem Found 213 Reported problem cannot be reproduced during investigation. IMDRF:C19 C C91802 CDRH Cause Investigation - Investigation Conclusion Terminology C139482 Sabotage or Intentional Misuse Problems occurred because of willful damage or reckless misuse. This term indicates that there was an apparent intent to cause damage or injury. Sabotage or Intentional Misuse 4313 Problems occurred because of willful damage or reckless misuse. This term indicates that there was an apparent intent to cause damage or injury. IMDRF:D1107 C C91802 CDRH Cause Investigation - Investigation Conclusion Terminology C91878 Known Inherent Risk of Device Reported adverse event known and documented in the labeling (including both short or long term known complications or adverse reactions). Known Inherent Risk of Device 22 Reported adverse event known and documented in the labeling and all reasonable mitigation steps have been taken (including both short or long term known complications or adverse reactions). IMDRF:D12 C C54450 CDRH Health Effect - Clinical Code Terminology C85079 Status Epilepticus A life-threatening situation in which the brain is in a continuous state of seizure. Status Epilepticus 4408 A life-threatening condition characterised by a single prolonged seizure or a series of seizures without intervening full recovery of consciousness. IMDRF:E010904 C C54450 CDRH Health Effect - Clinical Code Terminology C26920 Encephalopathy A functional and/or structural disorder of the brain caused by diseases (e.g. liver disease, kidney disease), medications, chemicals, and injuries. Encephalopathy 1833 A functional and/or structural disorder of the brain that is acquired or congenital and characterised by mental and neurological symptoms. IMDRF:E0115 C 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 C 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 C 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 C C54450 CDRH Health Effect - Clinical Code Terminology C50591 Hypervolemia Too much fluid in the blood. Hypervolemia 2664 An abnormally high circulating blood volume. IMDRF:E0304 C 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 C C54450 CDRH Health Effect - Clinical Code Terminology C26758 Ecchymosis A flat discoloration of the skin or a mucous membrane, larger in area than a petechia, caused by the extravasation of blood. Ecchymosis 1818 A flat discoloration of the skin or a mucous membrane, larger in area than a petechia, caused by the extravasation of blood. Discolouration under the skin caused by a bleed underneath. Typically a bruise. IMDRF:E050601 C C54450 CDRH Health Effect - Clinical Code Terminology C50642 Low Pulmonary Arterial Wedge Pressure The measurement of the mean left pulmonary arterial pressure, as measured by a catheter introduced into the distal pulmonary artery, is low. Low Pulmonary Arterial Wedge Pressure 2479 The measurement of the mean left atrial pressure, as measured by a catheter introduced into the distal pulmonary artery, is low. IMDRF:E0508 C 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 C 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 C 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 C 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 C C54450 CDRH Health Effect - Clinical Code Terminology C50473 Bowel Burn A thermal, chemical or radiation injury to the bowels. Bowel Burn 1756 A thermal injury to the bowels. IMDRF:E1005 C C54450 CDRH Health Effect - Clinical Code Terminology C171982 Gastroesophageal Burn A thermal, chemical or radiation injury to the stomach or esophagus. Gastroesophageal Burn 4475 Thermal, chemical or radiation injury to stomach or esophagus. IMDRF:E1013 C 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 C C54450 CDRH Health Effect - Clinical Code Terminology C51225 Biliary Cirrhosis Cirrhosis of the liver caused either by destruction of the intrahepatic bile ducts (primary biliary cirrhosis) or blockage of the extrahepatic bile ducts (secondary biliary cirrhosis). Biliary Cirrhosis 1736 Cirrhosis of the liver caused either by destruction of the intrahepatic bile ducts (primary biliary cholangitis) or blockage of the extrahepatic bile ducts (secondary biliary cholangitis). IMDRF:E1101 C 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 C 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 C C54450 CDRH Health Effect - Clinical Code Terminology C50795 Abnormal Vaginal Discharge Abnormal secretions from the vagina. Abnormal Vaginal Discharge 2123 Secretions from the vagina with a smell, colour, or texture which is different from normal. IMDRF:E1401 C 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 C 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 C 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 C C54450 CDRH Health Effect - Clinical Code Terminology C50758 Subclinical Infection Infection associated with no detectable symptoms but caused by microorganisms capable of producing easily recognizable diseases, such a poliomyelitis or mumps. Subclinical Infection 2247 Infection associated with no detectable signs or symptoms but caused by microorganisms capable of producing easily recognizable diseases. IMDRF:E1904 C C54450 CDRH Health Effect - Clinical Code Terminology C128346 Transmissible Spongiform Encephalopathy A transmissible, infectious disease that is caused by a protein that is able to induce abnormal folding of normal cellular proteins, leading to characteristic spongiform brain changes, which are associated with neuronal loss without an inflammatory response. Such disorders have typically long incubation periods, but are then generally rapidly progressive and are uniformly fatal. Transmissible Spongiform Encephalopathy(TSE) 4556 A group of rare degenerative brain disorders associated with orions for example Creutzfeldt-Jakob disease (CJD) or Bovine Spongiform Encephalopathy (BSE). IMDRF:E1905 C 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 C C54450 CDRH Health Effect - Clinical Code Terminology C50717 Purulent Discharge Pus-containing fluid that is draining from an orifice or wound. Purulent Discharge 1812 A flow or draining of pus or exudate from an oriface or wound. IMDRF:E231501 C C54450 CDRH Health Effect - Clinical Code Terminology C106101 Absence of Signs or Symptoms Absence of detectable signs or symptoms. No Clinical Signs, Symptoms or Conditions 4582 No patient involvement or, no observable clinical symptoms or a change in symptoms is identified in the patient. IMDRF:E2403 C C54577 CDRH Component Code Terminology C63845 Monomer A chemical subunit that can undergo polymerization by bonding to other subunits. Monomer Liquid 4702 The liquid that reacts with the polymer powder to form adhesive, resin, or cement. IMDRF:G01005 C C54577 CDRH Component Code Terminology C172021 Polymer Bone Powder The powder that reacts with the monomer liquid to form bone cement. Polymer Powder 4703 The powder that reacts with the monomer liquid to form adhesive, resin, or cement. IMDRF:G01007 C C54577 CDRH Component Code Terminology C49927 Device Display Device A device designed to present information visually. Display 416 A component designed to present information visually. In the case of Touchscreen, use G0204004. IMDRF:G02014 C C54577 CDRH Component Code Terminology C172140 Patient Electrode An electrical conductor that is designed to make contact with a patient. Patient Electrode 4760 An electrical conductor that is designed to make contact with a patient including defibrillator paddles. IMDRF:G0202502 C C54577 CDRH Component Code Terminology C50199 Switch Device A mechanical or electronic device designed to break or change the connections in a circuit. Switch/Relay 4712 A mechanical or electronic component designed to break or change the connections in a circuit (e.g. button). IMDRF:G02034 C C54577 CDRH Component Code Terminology C49844 Belt Device A device consisting of a narrow loop of material moving over shafts or pulleys. Belt 737 A component consisting of a narrow band of material moving over shafts or pulleys. IMDRF:G04013 C 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. || A vessel with a narrow neck designed to accept a specific closure. IMDRF:G04014 C C54577 CDRH Component Code Terminology C171949 Cannula Hub A small metal or plastic component that connects to the end of the intravenous cannula that is intended to connect to other devices, usually for medication or fluid delivery. Cannula Hub 4728 A metal or plastic component that connects to the cannula. IMDRF:G0401901 C 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. || Substance capable of bonding together two surfaces (e.g. bioadhesive material). IMDRF:G0405201 C C54577 CDRH Component Code Terminology C50365 Suture Device A natural (e.g., catgut, silk, or linen) or synthetic, or other (e.g., thin metal wire) monofilament or multifilament material used surgically to close a surgical or accidental wound and to secure apposition of the edges and join tissues. Suture Thread 3114 A monofilament or multifilament material used surgically to close a wound, join tissues, or fasten components of a device (e.g. fabric to wire stent frame). IMDRF:G0405215 C C54577 CDRH Component Code Terminology C49984 Heat Exchanger Device A device designed to transfer heat between fluids across a barrier or to the environment. Heat Exchanger 835 A component designed to transfer heat between fluids and/or gases across a barrier or to the environment. IMDRF:G04066 C C54577 CDRH Component Code Terminology C50190 Stent Device A device designed to support a tubular structure, especially the small stainless steel expandable mesh tube inserted within an artery. Stent 515 Tubular support placed inside a blood vessel, canal, or duct to aid healing or relieve an obstruction. IMDRF:G04122 C 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. || Object used to plug opening of container. IMDRF:G04124 C C54577 CDRH Component Code Terminology C172800 Tool A component that is not part of a device but is designed to support its assemby or operation. Tool 4774 A component that is delivered with a device to support its assembly or operation, and is not part of the device. Use only in the case there are no other terms to describe the component. IMDRF:G04130 C C54577 CDRH Component Code Terminology C50268 Window Device A transparent panel in a device designed for visual inspection. Window 3152 A transparent panel in a device designed for visual inspection or to let light pass. IMDRF:G04141 C C54577 CDRH Component Code Terminology C50171 Shield Device A device designed to form a protective covering or structure. Protector/Shield 4752 A component designed to prevent harm or protect against damage to other components. IMDRF:G06005 C C54577 CDRH Component Code Terminology C172015 Part/Component/Sub-assembly Term not Applicable The device does not have distinct parts, components, or sub-assemblies, or it would not be appropriate to link the reported incident to a single part, component, or sub-assembly. Part/Component/Sub-assembly Term not Applicable 4755 The device does not have distinct parts, components, or sub-assemblies, or it would not be appropriate to link the reported incident to a single part, component, or sub-assembly. Use this term if the problem involves or affects the overall device rather than a specific component. IMDRF:G07001