C FDA C54450 Patient Problem Codes FDA CDRH C34620 2687 FOREIGN BODY IN PATIENT An occurrence where any object originating inside or outside the body is not in it's physiological or intended location. For example, a tooth or bone fragment being swallowed; or device's components or fragments being found in the body away from where they were implanted. C54027 2688 PATIENT PROBLEM/MEDICAL PROBLEM C FDA C54450 Patient Problem Codes FDA CDRH C50436 2261 SEIZURES, ABSENCE PETIT-MAL SEIZURES|SEIZURES, PETIT-MAL The seizure seen in absence epilepsy, consisting of a sudden momentary break in consciousness of thought or activity, often accompanied by automatisms or clonic movements, especially of the eyelids. Generalized seizure that manifests in a form of a brief episode of impairment of consciousness with or without accompanying motor phenomena such as clonic-tonic components, automatisms, or autonomic components. C2962 2063 SEIZURES C FDA C54450 Patient Problem Codes FDA CDRH C50460 1703 SHOCK, ANAPHYLACTIC ANAPHYLACTIC SHOCK|ANAPHYLAXIS Systemic anaphylaxis is the most dramatic example of an immediate hypersensitivity reaction; is uncommon and unexpected in nature and occasionally results in a fatal outcome. An acute inflammatory reaction resulting from the release of histamine and histamine-like substances from mast cells, causing a hypersensitivity immune response. Clinically, it presents with breathing difficulty, dizziness, hypotension, cyanosis and loss of consciousness, and may lead to death. C35016 2072 SHOCK C FDA C54451 Medical Device Problem Codes FDA CDRH C63015 2284 DEVICE DAMAGED PRIOR TO USE DAMAGE, INTERNAL/EXTERNAL|DAMAGED ITEM|ITEM DAMAGED PRIOR TO USE C63020 2897 COMPONENT OR ACCESSORY INCOMPATIBILITY N FDA C91800 Medical Device Evaluation Methods Terminology FDA CDRH C54028 3291 EVALUATION METHOD C62596 N FDA C91800 Medical Device Evaluation Methods Terminology FDA CDRH C91896 10 ACTUAL DEVICE EVALUATED C54028 3291 EVALUATION METHOD N FDA C91800 Medical Device Evaluation Methods Terminology FDA CDRH C91897 3263 ACTUAL DEVICE NOT EVALUATED C54028 3291 EVALUATION METHOD N FDA C91800 Medical Device Evaluation Methods Terminology FDA CDRH C91898 3261 ACOUSTIC ENERGY TESTING Testing the device for its response to variations in air pressure produced by the vibration of an object. C91963 26 MECHANICAL EVALUATION N FDA C91800 Medical Device Evaluation Methods Terminology FDA CDRH C91899 3262 ACOUSTIC NOISE TESTING Testing the device's response to variations in air pressure for detecting any unwanted or unintentional sound. C91898 3261 ACOUSTIC ENERGY TESTING N FDA C91800 Medical Device Evaluation Methods Terminology FDA CDRH C91900 3264 AGENT CONTAMINATION TESTING Testing the device for the presence of chemicals or other agents that do not belong on the device (contamination). C91912 3277 CONTAMINATION TESTING N FDA C91800 Medical Device Evaluation Methods Terminology FDA CDRH C91901 3265 AGGLUTINATION TESTING Evaluating the device for characteristics that may cause blood to clot. C91938 3298 HEMATOLOGIC TESTING N FDA C91800 Medical Device Evaluation Methods Terminology FDA CDRH C91902 3266 ASSEMBLY AND PACKAGING REVIEW Performing a review of the assembly and packaging processes and records for a specific device or lot that may have contributed to problems with the device. C91978 3331 PROCESS EVALUATION N FDA C91800 Medical Device Evaluation Methods Terminology FDA CDRH C91903 3267 BIOASSAY EVALUATION Measuring the effects of a substance on a living organism. Bioassays may be qualitative or quantitative. Qualitative bioassays are used for assessing the physical effects of a substance that may not be quantified, such as abnormal development or deformity. C91905 3269 BIOLOGIC EVALUATION N FDA C91800 Medical Device Evaluation Methods Terminology FDA CDRH C91904 3268 BIOCOMPATIBILITY TESTING Testing the device to determine if it elicits an undesirable local or systemic biological effect in the cells or tissues of the recipient of that device. This includes testing the device for its toxicity to cells. C91905 3269 BIOLOGIC EVALUATION N FDA C91800 Medical Device Evaluation Methods Terminology FDA CDRH C91905 3269 BIOLOGIC EVALUATION C54028 3291 EVALUATION METHOD N FDA C91800 Medical Device Evaluation Methods Terminology FDA CDRH C91906 3270 CARCINOGENIC TESTING Testing the device's ability to promote cancer or facilitate its propagation. C91934 3294 GENOTOXIC TESTING N FDA C91800 Medical Device Evaluation Methods Terminology FDA CDRH C91907 3271 CELL EVALUATION Evaluating a device's characteristics that may affect cells. C92015 3364 TISSUE ENGINEERING EVALUATION N FDA C91800 Medical Device Evaluation Methods Terminology FDA CDRH C91908 3274 COMPLEMENT ACTIVATION TESTING Evaluating a device's ability to activate the process of clearing pathogens from a organism. C91938 3298 HEMATOLOGIC TESTING N FDA C91800 Medical Device Evaluation Methods Terminology FDA CDRH C91909 3275 COMPOSITION TESTING Testing the device to determine if the correct combination of materials or elements is present (e.g., the composition of the materials of a capacitor). C91961 3318 MATERIALS AND CHEMISTRY EVALUATION N FDA C91800 Medical Device Evaluation Methods Terminology FDA CDRH C91910 28 COMPRESSION TESTING Testing the device for problems that can occur as the result of excessive stress or pressure applied to the device resulting in its compaction (decrease of volume). C92005 3355 STRESS TESTING N FDA C91800 Medical Device Evaluation Methods Terminology FDA CDRH C91911 3276 CONDUCTED EMISSIONS TESTING Testing the ability of a device's conducted emissions to cause another device to fail (i.e. electromagnetic disturbance for which the energy is transferred via one or more conductors). C91925 3289 EMISSIONS TESTING N FDA C91800 Medical Device Evaluation Methods Terminology FDA CDRH C91912 3277 CONTAMINATION TESTING Testing the device to detect the presence of any substance that can cause infection or fever. C91905 3269 BIOLOGIC EVALUATION N FDA C91800 Medical Device Evaluation Methods Terminology FDA CDRH C91913 3278 CREEP (STRENGTH) TESTING Testing the device's ability to withstand a constant tensile load at elevated temperatures. (Creep is the form of plastic deformation that takes place in steel held for long periods at high temperature.) C92005 3355 STRESS TESTING N FDA C91800 Medical Device Evaluation Methods Terminology FDA CDRH C91914 3279 CURRENT LEAKAGE TESTING Testing to detect the amount of electricity leakage from the device. C91919 23 ELECTRICAL EVALUATION N FDA C91800 Medical Device Evaluation Methods Terminology FDA CDRH C91915 3280 DATA VALIDATION Ensuring that data used and generated by a program is correct. C91993 22 SOFTWARE EVALUATION N FDA C91800 Medical Device Evaluation Methods Terminology FDA CDRH C91916 3281 DEGRADATION/CORROSION/EROSION TESTING Testing the device for its corrosive behavior to specific environments or materials. Tests may include polarization, potentiostatic, galvanic, critical pitting/crevice temperature, and inhibitor testing. C91961 3318 MATERIALS AND CHEMISTRY EVALUATION N FDA C91800 Medical Device Evaluation Methods Terminology FDA CDRH C91917 3282 DESIGN VALIDATION Validating that the device meets the user's needs and intended uses. C91995 3347 SOFTWARE VALIDATION N FDA C91800 Medical Device Evaluation Methods Terminology FDA CDRH C91918 3283 ELASTICITY TESTING Testing the device's ability to recover its size and shape after being deformed during the test. C92005 3355 STRESS TESTING N FDA C91800 Medical Device Evaluation Methods Terminology FDA CDRH C91919 23 ELECTRICAL EVALUATION C54028 3291 EVALUATION METHOD N FDA C91800 Medical Device Evaluation Methods Terminology FDA CDRH C91920 3284 ELECTRICAL FAST BURST TESTING Testing the device for failures related to interference voltage tests which are bursts of electrical pulses (e.g. when a switch is turned on or off or the device is plugged in or out). C91942 3301 IMMUNITY TESTING N FDA C91800 Medical Device Evaluation Methods Terminology FDA CDRH C91921 3285 ELECTRICAL SLOW FLUCTUATION TESTING Testing the device to detect malfunctions caused by a sudden reduction of the voltage at a particular point in an electricity supply system below a specified "dip" threshold followed by its recovery after a brief interval. C91942 3301 IMMUNITY TESTING N FDA C91800 Medical Device Evaluation Methods Terminology FDA CDRH C91922 3286 ELECTROMAGNETIC COMPATIBILITY (EMC) EVALUATION Evaluating a device to detect malfunctions caused by electromagnetic interference (unwanted disturbances from an external force e.g. radios, cell phones, or unintentional disturbances of another device) C54028 3291 EVALUATION METHOD N FDA C91800 Medical Device Evaluation Methods Terminology FDA CDRH C91923 3287 ELECTRON MICROSCOPY Inspection of objects or surfaces requiring magnification using an electron microscope. C91965 3321 MICROSCOPIC INSPECTION N FDA C91800 Medical Device Evaluation Methods Terminology FDA CDRH C91924 3288 ELECTROSTATIC DISCHARGE TESTING Testing the device for malfunctions related to the transfer of an electrostatic charge (by direct contact or from electrostatic fields) between objects of different potentials. C91942 3301 IMMUNITY TESTING N FDA C91800 Medical Device Evaluation Methods Terminology FDA CDRH C91925 3289 EMISSIONS TESTING Testing the device for adequately controlled electromagnetic emissions. C91922 3286 ELECTROMAGNETIC COMPATIBILITY (EMC) EVALUATION N FDA C91800 Medical Device Evaluation Methods Terminology FDA CDRH C91926 3290 ENVIRONMENT EVALUATION Evaluating devices for responses to physical characteristics in their surroundings. C54028 3291 EVALUATION METHOD N FDA C91800 Medical Device Evaluation Methods Terminology FDA CDRH C91927 27 FATIGUE TESTING Testing the device's capability to withstand the progressive and localized structural damage that occurs when a material is subjected to cyclic loading. This is a dynamic mechanical test for wear or fatigue. C92005 3355 STRESS TESTING N FDA C91800 Medical Device Evaluation Methods Terminology FDA CDRH C91928 89 FLOW TESTING Testing the device to assess the volume of fluid moving per unit of time. This may also include filter testing. C91963 26 MECHANICAL EVALUATION N FDA C91800 Medical Device Evaluation Methods Terminology FDA CDRH C91929 3292 FLUID PRESSURE TESTING Testing the fluid pressure (pressure at some point within a fluid e.g. water or air) within a device. C91963 26 MECHANICAL EVALUATION N FDA C91800 Medical Device Evaluation Methods Terminology FDA CDRH C91930 3293 FRACTURE TOUGHNESS TESTING Testing the device's ability to resist local separation into two, or more, pieces under the action of stress. C92005 3355 STRESS TESTING N FDA C91800 Medical Device Evaluation Methods Terminology FDA CDRH C91931 13 DEVICE FROM CONTROLLED OR NON-RELEASED SAMPLE EVALUATED C91897 3263 ACTUAL DEVICE NOT EVALUATED N FDA C91800 Medical Device Evaluation Methods Terminology FDA CDRH C91932 12 DEVICE FROM RESERVE SAMPLE EVALUATED C91897 3263 ACTUAL DEVICE NOT EVALUATED N FDA C91800 Medical Device Evaluation Methods Terminology FDA CDRH C91933 11 DEVICE FROM SAME LOT EVALUATED C91897 3263 ACTUAL DEVICE NOT EVALUATED N FDA C91800 Medical Device Evaluation Methods Terminology FDA CDRH C91934 3294 GENOTOXIC TESTING Testing the device's ability to cause damage to genetic material. (e.g., leading to outgrowths -- malignant tumors). C91905 3269 BIOLOGIC EVALUATION N FDA C91800 Medical Device Evaluation Methods Terminology FDA CDRH C91935 3295 GRADIENT-INDUCED FIELD EFFECT TESTING Testing the RF shield around the coils of an MRI device for its ability to provide effective screening against electrical (eddy) currents induced by gradient switching. C91982 3336 RADIOGRAPHIC INSPECTION N FDA C91800 Medical Device Evaluation Methods Terminology FDA CDRH C91936 3296 GROWTH FACTOR EVALUATION Evaluating a device's characteristics that may affect the self healing ability of an organism. C92015 3364 TISSUE ENGINEERING EVALUATION N FDA C91800 Medical Device Evaluation Methods Terminology FDA CDRH C91937 3297 HARDNESS TESTING Testing the device's ability to resist deformation. Hardness is the property of a material that enables it to resist plastic deformation, usually by penetration. However, the term hardness may also refer to resistance to bending, scratching, abrasion or cutting. The usual method to achieve a hardness value is to measure the depth or area of an indentation left by an indenter of a specific shape, with a specific force applied for a specific time. C92005 3355 STRESS TESTING N FDA C91800 Medical Device Evaluation Methods Terminology FDA CDRH C91938 3298 HEMATOLOGIC TESTING Testing the device for its affect or impact on the blood or its components. C91905 3269 BIOLOGIC EVALUATION N FDA C91800 Medical Device Evaluation Methods Terminology FDA CDRH C91939 82 HUMIDITY TESTING Testing the device's protective materials to prevent moisture penetration or ingress. C91926 3290 ENVIRONMENT EVALUATION N FDA C91800 Medical Device Evaluation Methods Terminology FDA CDRH C91940 3299 IMAGE ARTIFACT TESTING Testing an imaging device to determine the amount of distortion or signal loss (artifacts) produced in an image. C91983 3337 RADIOLOGIC EVALUATION N FDA C91800 Medical Device Evaluation Methods Terminology FDA CDRH C91941 3300 IMAGE INSPECTION Macroscopic inspection commonly used to describe physical objects that are measurable and observable by the naked eye. C92023 38 VISUAL INSPECTION N FDA C91800 Medical Device Evaluation Methods Terminology FDA CDRH C91942 3301 IMMUNITY TESTING Testing the device for adequate immunity or capability to resist electromagnetic interference (EMI). C91922 3286 ELECTROMAGNETIC COMPATIBILITY (EMC) EVALUATION N FDA C91800 Medical Device Evaluation Methods Terminology FDA CDRH C91943 3302 IMPACT TESTING Testing the device's response to a suddenly applied stress. The test ascertains whether the material is tough or brittle. C92005 3355 STRESS TESTING N FDA C91800 Medical Device Evaluation Methods Terminology FDA CDRH C91944 3303 IMPEDANCE TESTING Testing the resistance to current flow in a device's circuit or component. C91919 23 ELECTRICAL EVALUATION N FDA C91800 Medical Device Evaluation Methods Terminology FDA CDRH C91945 3304 IN SITU OBSERVATION Observing the device in the exact same conditions and setting in which the device was used. C92020 3367 USE TESTING N FDA C91800 Medical Device Evaluation Methods Terminology FDA CDRH C91946 3305 INFRASOUND TESTING C91898 3261 ACOUSTIC ENERGY TESTING N FDA C91800 Medical Device Evaluation Methods Terminology FDA CDRH C91947 3306 INGRESS PROTECTION TESTING Testing the device's ability to protect against ingress or access of unwanted fluids or solids. C91963 26 MECHANICAL EVALUATION N FDA C91800 Medical Device Evaluation Methods Terminology FDA CDRH C91948 3307 INSTALLATION REVIEW Performing a review of the processes used to install a device and the records reflecting these processes performed for a specific device. C91978 3331 PROCESS EVALUATION N FDA C91800 Medical Device Evaluation Methods Terminology FDA CDRH C91949 3308 INSULATION TESTING Testing the ability of a device's or component's material to resist the flow of electric current. C91919 23 ELECTRICAL EVALUATION N FDA C91800 Medical Device Evaluation Methods Terminology FDA CDRH C91950 3309 INTERFERENCE SUBSTANCE TESTING A test used with in vitro diagnostic analytic systems to detect substances that may be interfering with test results and causing errors. C91905 3269 BIOLOGIC EVALUATION N FDA C91800 Medical Device Evaluation Methods Terminology FDA CDRH C91951 20 INTEROPERABILITY EVALUATION Testing devices for problems with the mechanical, electrical, or communication interface between two or more separate devices or components. C54028 3291 EVALUATION METHOD N FDA C91800 Medical Device Evaluation Methods Terminology FDA CDRH C91952 3310 IONIZING RADIATION TESTING Testing that ionizing radiation is delivered at the appropriate energy and dose to the appropriate region of interest for the exam or therapy under evaluation. C91983 3337 RADIOLOGIC EVALUATION N FDA C91800 Medical Device Evaluation Methods Terminology FDA CDRH C91953 36 LABELING EVALUATION Reviewing all labeling (including instructions for use, manuals, and packaging) for language related to reported device problems. C54028 3291 EVALUATION METHOD N FDA C91800 Medical Device Evaluation Methods Terminology FDA CDRH C91954 3311 LIGHT SOURCE PERFORMANCE EVALUATION Testing the optical properties of a device such as diopter, glare, and irradiance or glistening. C54028 3291 EVALUATION METHOD N FDA C91800 Medical Device Evaluation Methods Terminology FDA CDRH C91955 3312 LIGHT TESTING Testing the device's characteristics when subjected to variations of ambient light within its surroundings. C91926 3290 ENVIRONMENT EVALUATION N FDA C91800 Medical Device Evaluation Methods Terminology FDA CDRH C91956 3313 LINE VOLTAGE TESTING Tests to determine whether a device's insulation has the strength to prevent any current from reaching the operator. C91919 23 ELECTRICAL EVALUATION N FDA C91800 Medical Device Evaluation Methods Terminology FDA CDRH C91957 3314 MAGNETICALLY-INDUCED DISPLACEMENT FORCE TESTING Testing the static magnetic field gradients on medical imaging devices for their ability to move objects. C91983 3337 RADIOLOGIC EVALUATION N FDA C91800 Medical Device Evaluation Methods Terminology FDA CDRH C91958 3315 MAGNETICALLY-INDUCED TORQUE TESTING Testing the static magnetic field gradients on medical imaging devices for their ability to rotate objects. C91983 3337 RADIOLOGIC EVALUATION N FDA C91800 Medical Device Evaluation Methods Terminology FDA CDRH C91959 3316 MAINTENANCE REVIEW Performing a review the technical and corresponding administrative actions and records intended to retain an item in, or restore it to, a state in which it can perform its required function. This evaluation includes reviewing the user's maintenance procedures and processes as to whether they were followed. C91978 3331 PROCESS EVALUATION N FDA C91800 Medical Device Evaluation Methods Terminology FDA CDRH C91960 3317 MANUFACTURING REVIEW Performing a review of the manufacturing steps and processes to ensure that they were met and followed and that the device records reflected these processes. C91978 3331 PROCESS EVALUATION N FDA C91800 Medical Device Evaluation Methods Terminology FDA CDRH C91961 3318 MATERIALS AND CHEMISTRY EVALUATION Testing devices for malfunctions that arise from problems with its components or materials or how its materials or components react to other elements either within the device or within the environment. C54028 3291 EVALUATION METHOD N FDA C91800 Medical Device Evaluation Methods Terminology FDA CDRH C91962 3319 MATERIAL OR MATERIAL LEACHATE PYROGENIC TESTING Testing the device for the presence of unwanted agents (e.g. pyrogens) caused by materials that permeate through the device. C91912 3277 CONTAMINATION TESTING N FDA C91800 Medical Device Evaluation Methods Terminology FDA CDRH C91963 26 MECHANICAL EVALUATION Testing the device for problems that result from external forces including fluids, other objects, or environmental or physiologic influences. C54028 3291 EVALUATION METHOD N FDA C91800 Medical Device Evaluation Methods Terminology FDA CDRH C91964 3320 MICROBIAL CONTAMINATION TESTING Testing the device for the presence of microorganisms such as bacteria, viruses, and fungi (yeasts and molds). C91912 3277 CONTAMINATION TESTING N FDA C91800 Medical Device Evaluation Methods Terminology FDA CDRH C91965 3321 MICROSCOPIC INSPECTION Inspection of objects or surfaces requiring magnification using a microscope e.g. with electron, optical, or scanning probe microscopy. C92023 38 VISUAL INSPECTION N FDA C91800 Medical Device Evaluation Methods Terminology FDA CDRH C91966 3322 MUTAGENIC TESTING Testing the device's ability to change genetic information (usually DNA) of an organism and thus increasing the frequency of mutations. C91934 3294 GENOTOXIC TESTING N FDA C91800 Medical Device Evaluation Methods Terminology FDA CDRH C91967 3323 NO TESTING METHODS PERFORMED Testing was not performed on the device. C91897 3263 ACTUAL DEVICE NOT EVALUATED N FDA C91800 Medical Device Evaluation Methods Terminology FDA CDRH C91968 84 OPTICAL MICROSCOPY Inspection of objects or surfaces requiring magnification using an optical microscope. C91965 3321 MICROSCOPIC INSPECTION N FDA C91800 Medical Device Evaluation Methods Terminology FDA CDRH C91969 3324 OVERCURRENT PROTECTION TESTING Testing the device's over-current protection circuitry for its response to situations of overload, short circuit, or ground fault. C91919 23 ELECTRICAL EVALUATION N FDA C91800 Medical Device Evaluation Methods Terminology FDA CDRH C91970 3325 PACKAGING VERIFICATION Verifying that the device packaging met proper sterilization conditions and that the effectiveness of the packaging kept the device free viable microorganisms. C92002 3352 STERILIZATION PROCESS REVIEW N FDA C91800 Medical Device Evaluation Methods Terminology FDA CDRH C91971 83 PATHOLOGICAL EXAMINATION Examining material that may have contributed to the disease or damage. Often performed using a microscope by measuring structural changes that occur along with the disease or damage. C91905 3269 BIOLOGIC EVALUATION N FDA C91800 Medical Device Evaluation Methods Terminology FDA CDRH C91972 37 PHOTOGRAPHIC INSPECTION C91941 3300 IMAGE INSPECTION N FDA C91800 Medical Device Evaluation Methods Terminology FDA CDRH C91973 3326 PHYSICAL STRUCTURE TESTING Testing the device for problems related to the incorrect or inadequate arrangement of the parts, components, elements, or materials. C91961 3318 MATERIALS AND CHEMISTRY EVALUATION N FDA C91800 Medical Device Evaluation Methods Terminology FDA CDRH C91974 3327 PLATELET ACTIVATION TESTING Testing the device for characteristics that lead to the activation of platelets which are essential to stop bleeding and repair the tissue. Platelets also play a key role in the development of acute coronary syndromes and contribute to cerebrovascular events. C91938 3298 HEMATOLOGIC TESTING N FDA C91800 Medical Device Evaluation Methods Terminology FDA CDRH C91975 3328 POWER FREQUENCY MAGNETIC FIELD TESTING Tests performed to verify a device's level of protection (immunity) against magnetic disturbances while operating. C91942 3301 IMMUNITY TESTING N FDA C91800 Medical Device Evaluation Methods Terminology FDA CDRH C91976 3329 POWER SOURCE TESTING Testing the power sources in a device e.g., battery, internal power supply to detect any malfunction. C91919 23 ELECTRICAL EVALUATION N FDA C91800 Medical Device Evaluation Methods Terminology FDA CDRH C91977 3330 PRESSURE TESTING Testing the device's characteristics when subjected to high or low pressure conditions. C91926 3290 ENVIRONMENT EVALUATION N FDA C91800 Medical Device Evaluation Methods Terminology FDA CDRH C91978 3331 PROCESS EVALUATION Performing a review of the manufacturing and production processes and/or records for a specific device or lot that may have contributed to problems with a device. C54028 3291 EVALUATION METHOD N FDA C91800 Medical Device Evaluation Methods Terminology FDA CDRH C91979 3332 QUALITY CONTROL REVIEW Performing a review of the processes used in developing systems to ensure that products are designed and produced and services are developed to meet or exceed device specifications and customer expectations. C91978 3331 PROCESS EVALUATION N FDA C91800 Medical Device Evaluation Methods Terminology FDA CDRH C91980 3333 RADIATED EMISSIONS TESTING Testing the ability of a device's radiated emissions to cause another device to fail (i.e. electromagnetic disturbance for which the energy is transferred through space in the form of electromagnetic waves). C91925 3289 EMISSIONS TESTING N FDA C91800 Medical Device Evaluation Methods Terminology FDA CDRH C91981 3335 RADIOFREQUENCY INTERFERENCE TESTING Testing the device to detect device malfunctions caused by a disturbance affecting an electrical circuit due to electromagnetic radiation emitted from an external source. This includes susceptibility to interference via cables or air. C91942 3301 IMMUNITY TESTING N FDA C91800 Medical Device Evaluation Methods Terminology FDA CDRH C91982 3336 RADIOGRAPHIC INSPECTION C91941 3300 IMAGE INSPECTION N FDA C91800 Medical Device Evaluation Methods Terminology FDA CDRH C91983 3337 RADIOLOGIC EVALUATION Evaluating the safety provisions in a device used for medical imaging, i.e., if the device can cause injury to individuals during imaging process (visualizing the structure and function of the body). C91919 23 ELECTRICAL EVALUATION N FDA C91800 Medical Device Evaluation Methods Terminology FDA CDRH C91984 3338 REACTIVITY TESTING Testing the device for problems related to how the materials react to other factors (e.g. over-react or under-react). C91961 3318 MATERIALS AND CHEMISTRY EVALUATION N FDA C91800 Medical Device Evaluation Methods Terminology FDA CDRH C91985 3339 REPRODUCTIVE TOXICITY EVALUATION Evaluating a device for chemicals or other agents that may have caused problems with the reproductive system. This includes evaluating a device for chemicals or agents that may have caused or contributed to birth defects or malformations (teratogenic evaluation). C91905 3269 BIOLOGIC EVALUATION N FDA C91800 Medical Device Evaluation Methods Terminology FDA CDRH C91986 95 RESERVE SAMPLE FROM DIFFERENT LOT TESTED, NO FAILURE DETECTED C91932 12 DEVICE FROM RESERVE SAMPLE EVALUATED N FDA C91800 Medical Device Evaluation Methods Terminology FDA CDRH C91987 3340 RESERVE SAMPLE TESTED FROM SAME LOT, NO FAILURE DETECTED C91932 12 DEVICE FROM RESERVE SAMPLE EVALUATED N FDA C91800 Medical Device Evaluation Methods Terminology FDA CDRH C91988 3341 RADIOFREQUENCY INDUCED HEAT TESTING Testing the static magnetic field gradients on medical imaging devices for their ability to induce heat in objects. C91983 3337 RADIOLOGIC EVALUATION N FDA C91800 Medical Device Evaluation Methods Terminology FDA CDRH C91989 3342 SCAFFOLD EVALUATION Evaluating a device's characteristics for its affects on the reproduction of tissues. C92015 3364 TISSUE ENGINEERING EVALUATION N FDA C91800 Medical Device Evaluation Methods Terminology FDA CDRH C91990 3343 SCANNING PROBE MICROSCOPY Inspection of objects or surfaces requiring magnification using a scanning probe microscope. C91965 3321 MICROSCOPIC INSPECTION N FDA C91800 Medical Device Evaluation Methods Terminology FDA CDRH C91991 3344 SHOCK TESTING Examining a device for problems resulting from transient physical insults such as dropping or shaking the device. C92005 3355 STRESS TESTING N FDA C91800 Medical Device Evaluation Methods Terminology FDA CDRH C91992 3345 SIMULATED USE TESTING Testing the devices in situations that mimic real life settings but do not involve patients. C92020 3367 USE TESTING N FDA C91800 Medical Device Evaluation Methods Terminology FDA CDRH C91993 22 SOFTWARE EVALUATION C54028 3291 EVALUATION METHOD N FDA C91800 Medical Device Evaluation Methods Terminology FDA CDRH C91994 3346 SOFTWARE STRESS TESTING Tests conducted to evaluate a software application at or beyond the limits of its specified requirements. C91996 3348 SOFTWARE VERIFICATION N FDA C91800 Medical Device Evaluation Methods Terminology FDA CDRH C91995 3347 SOFTWARE VALIDATION Validating that a system or component during or at the end of the development process satisfies specified requirements (the process may include algorithm evaluation). C91993 22 SOFTWARE EVALUATION N FDA C91800 Medical Device Evaluation Methods Terminology FDA CDRH C91996 3348 SOFTWARE VERIFICATION A process used to verify that a system or component performs according to the original set of conditions at any point in development. C91993 22 SOFTWARE EVALUATION N FDA C91800 Medical Device Evaluation Methods Terminology FDA CDRH C91997 3273 CODE REVIEW A systematic review of source code intended to find and fix mistakes possibly overlooked in the initial development phase. C91993 22 SOFTWARE EVALUATION N FDA C91800 Medical Device Evaluation Methods Terminology FDA CDRH C91998 3272 CODE VALIDATION Ensuring that common error patterns and violations of best practices in coding have been followed. C91995 3347 SOFTWARE VALIDATION N FDA C91800 Medical Device Evaluation Methods Terminology FDA CDRH C91999 3349 SPECTROSCOPY Testing the device using a spectrometer or spectrograph for the dispersion of visible light (includes electromagnetic, electron, and acoustic spectroscopy). C92023 38 VISUAL INSPECTION N FDA C91800 Medical Device Evaluation Methods Terminology FDA CDRH C92000 3350 STATIC ANALYSIS The process of analyzing the software code without running it. For example, formal verification, which is proving or disproving the correctness of intended algorithms underlying a system with respect to a certain formal specification or property using formal methods of mathematics e.g. model checking, theorem proving, symbolic verification). C91996 3348 SOFTWARE VERIFICATION N FDA C91800 Medical Device Evaluation Methods Terminology FDA CDRH C92001 3351 STERILITY METHOD VERIFICATION Verifying that the methods used to free a medical device from viable microorganisms such as fungi, bacteria, and viruses were followed. C92002 3352 STERILIZATION PROCESS REVIEW N FDA C91800 Medical Device Evaluation Methods Terminology FDA CDRH C92002 3352 STERILIZATION PROCESS REVIEW Performing a review of the records and processes used to render a product free from viable microorganisms. C91978 3331 PROCESS EVALUATION N FDA C91800 Medical Device Evaluation Methods Terminology FDA CDRH C92003 3353 STORAGE AND SHIPMENT REVIEW Performing a review of the storage and shipping processes and requirements. C91978 3331 PROCESS EVALUATION N FDA C91800 Medical Device Evaluation Methods Terminology FDA CDRH C92004 3354 STRENGTH TESTING Testing the device's ability to resist forces that attempt to break or deform the device. This evaluation includes testing tension such as pull testing. C92005 3355 STRESS TESTING N FDA C91800 Medical Device Evaluation Methods Terminology FDA CDRH C92005 3355 STRESS TESTING Testing the device for failures caused by applying force per unit area. This test includes durability testing. C91963 26 MECHANICAL EVALUATION N FDA C91800 Medical Device Evaluation Methods Terminology FDA CDRH C92006 39 DEVICE STRUCTURE TESTING Testing devices for 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). C91961 3318 MATERIALS AND CHEMISTRY EVALUATION N FDA C91800 Medical Device Evaluation Methods Terminology FDA CDRH C92007 3356 SURGE PROTECTION TESTING Testing the device's ability to protect itself of other devices against sudden bursts of current or voltage. C91942 3301 IMMUNITY TESTING N FDA C91800 Medical Device Evaluation Methods Terminology FDA CDRH C92008 3357 SURGE RESPONSE TESTING Testing for a response to a transient electrical current or voltage. C91919 23 ELECTRICAL EVALUATION N FDA C91800 Medical Device Evaluation Methods Terminology FDA CDRH C92009 3358 SYSTEM TESTING Tests conducted on a complete, integrated system to evaluate the system's compliance with its specified requirements. C91996 3348 SOFTWARE VERIFICATION N FDA C91800 Medical Device Evaluation Methods Terminology FDA CDRH C92010 3359 TEMPERATURE TESTING Testing the device's characteristics when subjected to temperature change (cycling), and high or low temperatures. C91926 3290 ENVIRONMENT EVALUATION N FDA C91800 Medical Device Evaluation Methods Terminology FDA CDRH C92011 3360 TEST FOR HIGH TEMPERATURE CONDITIONS C92013 3362 THERMAL ENERGY EVALUATION N FDA C91800 Medical Device Evaluation Methods Terminology FDA CDRH C92012 3361 TEST FOR LOW TEMPERATURE CONDITIONS C92013 3362 THERMAL ENERGY EVALUATION N FDA C91800 Medical Device Evaluation Methods Terminology FDA CDRH C92013 3362 THERMAL ENERGY EVALUATION Testing the device for conditions related to extremes of temperature. C54028 3291 EVALUATION METHOD N FDA C91800 Medical Device Evaluation Methods Terminology FDA CDRH C92014 3363 THROMBOTIC TESTING Testing the device for characteristics related to forming blood clots along the walls of blood vessels which can cause blockages and affect blood flow through vessels. C91938 3298 HEMATOLOGIC TESTING N FDA C91800 Medical Device Evaluation Methods Terminology FDA CDRH C92015 3364 TISSUE ENGINEERING EVALUATION Evaluating a device's characteristics that may affect tissues (e.g. bone, cartilage, blood vessels, bladder). C91905 3269 BIOLOGIC EVALUATION N FDA C91800 Medical Device Evaluation Methods Terminology FDA CDRH C92016 34 DEVICE-TO-DEVICE INTERACTION TESTING Tests conducted to assess the mechanical, electrical, or electronic compatibility of two or more devices. C91951 20 INTEROPERABILITY EVALUATION N FDA C91800 Medical Device Evaluation Methods Terminology FDA CDRH C92017 35 DEVICE-TO-HUMAN INTERACTION TESTING Tests conducted to assess the interaction between a device and the user C91951 20 INTEROPERABILITY EVALUATION N FDA C91800 Medical Device Evaluation Methods Terminology FDA CDRH C92018 3365 ULTRASONIC SOUND TESTING Testing the devices response to variations in air pressure for detecting sound with frequencies greater than upper limit of human hearing (> 20 kHz). C91898 3261 ACOUSTIC ENERGY TESTING N FDA C91800 Medical Device Evaluation Methods Terminology FDA CDRH C92019 3366 UNIT TESTING Testing of individual hardware or software components or groups of related units. C91996 3348 SOFTWARE VERIFICATION N FDA C91800 Medical Device Evaluation Methods Terminology FDA CDRH C92020 3367 USE TESTING Any testing performed that simulates real use situations experienced by users. C91951 20 INTEROPERABILITY EVALUATION N FDA C91800 Medical Device Evaluation Methods Terminology FDA CDRH C92021 3368 USER SURVEY Questioning a pre-defined group of users about their practices. C92020 3367 USE TESTING N FDA C91800 Medical Device Evaluation Methods Terminology FDA CDRH C92022 3369 VIBRATION TESTING Evaluating a device for problems resulting from periodic or random mechanical oscillations which could induce damage. C92005 3355 STRESS TESTING N FDA C91800 Medical Device Evaluation Methods Terminology FDA CDRH C92023 38 VISUAL INSPECTION C54028 3291 EVALUATION METHOD N FDA C91800 Medical Device Evaluation Methods Terminology FDA CDRH C92024 3370 VOLTAGE FLUCTUATION TESTING Testing the device for its immunity when subjected to positive and negative low amplitude voltage fluctuations. C91919 23 ELECTRICAL EVALUATION N FDA C91800 Medical Device Evaluation Methods Terminology FDA CDRH C92025 3371 WEAR TESTING Examining a device for signs of unexpected erosion on its surface or other components or parts. C92005 3355 STRESS TESTING N FDA C91801 Medical Device Evaluation Results Terminology FDA CDRH C54029 3249 EVALUATION RESULT C62596 N FDA C91801 Medical Device Evaluation Results Terminology FDA CDRH C92026 3202 AGGLUTINATION The device affects the ability of the blood to clot which may be induced by chemical, mechanical, or thermal properties of the device. C92060 3255 HEMATOLOGIC PROBLEM N FDA C91801 Medical Device Evaluation Results Terminology FDA CDRH C92027 635 ARITHMETIC ERROR The device software performed an incorrect arithmetic operation. C92115 3240 SOFTWARE RUNTIME ERROR N FDA C91801 Medical Device Evaluation Results Terminology FDA CDRH C92028 706 ASSEMBLY PROBLEM A device problem that occurred because the device was assembled or put together incorrectly. C92076 170 MANUFACTURING PROCESS PROBLEM N FDA C91801 Medical Device Evaluation Results Terminology FDA CDRH C92029 3203 BIOCOMPATIBILITY PROBLEM 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 3204 BIOLOGICAL PROBLEM N FDA C91801 Medical Device Evaluation Results Terminology FDA CDRH C92030 3204 BIOLOGICAL PROBLEM C54029 3249 EVALUATION RESULT N FDA C91801 Medical Device Evaluation Results Terminology FDA CDRH C92031 3205 CARCINOGENIC PROBLEM The device's ability to promote cancer or facilitate its propagation. C92057 3254 GENOTOXIC PROBLEM N FDA C91801 Medical Device Evaluation Results Terminology FDA CDRH C92032 3209 DAMAGE DUE TO CHEMICAL AGENT A device that experienced damage as the result of a chemical agent used during the sterilization process e.g. excessive residual chemical or an incompatible sterilant. C92033 201 CLEANING, DISINFECTING AND STERILIZATION PROBLEM N FDA C91801 Medical Device Evaluation Results Terminology FDA CDRH C92033 201 CLEANING, DISINFECTING AND STERILIZATION PROBLEM A device problem that occurred during or as the result of the cleaning, disinfecting, or sterilizing process. C92076 170 MANUFACTURING PROCESS PROBLEM N FDA C91801 Medical Device Evaluation Results Terminology FDA CDRH C92034 628 COMMUNICATIONS PROBLEM Devices that do not send or receive adequate signals (this speaks to the interoperability between devices). C92070 3213 INTEROPERABILITY PROBLEM N FDA C91801 Medical Device Evaluation Results Terminology FDA CDRH C92035 3206 COMPLEMENT ACTIVATION The device interferes with an organism's ability to clear pathogens which may be caused by an interaction with chemicals or materials. C92060 3255 HEMATOLOGIC PROBLEM N FDA C91801 Medical Device Evaluation Results Terminology FDA CDRH C92036 3207 COMPONENT MIGRATION A device or a component of a device that has moved from its original location due to external forces (e.g. stent or lead movement). C92079 180 MECHANICAL PROBLEM N FDA C91801 Medical Device Evaluation Results Terminology FDA CDRH C92037 658 CONDUCTED INTERFERENCE A device that experienced 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 197 ELECTROMAGNETIC COMPATIBILITY PROBLEM N FDA C91801 Medical Device Evaluation Results Terminology FDA CDRH C92038 3208 CONFIGURATION ISSUE Device problems due to incorrect version or change control. C92113 104 SOFTWARE PROBLEM N FDA C91801 Medical Device Evaluation Results Terminology FDA CDRH C92039 663 DATA COMPRESSION ERROR Data was lost or corrupted during the operation of reducing storage space or communication bandwidth. C92042 110 DESIGN ERROR N FDA C91801 Medical Device Evaluation Results Terminology FDA CDRH C92040 3211 DEFORMATION PROBLEM Device problems caused by changes in the shape or size of the device or device component due to an applied force. This can be a result of tensile forces, compressive forces, shear, bending, tensile (pulling), or torsion. C92120 3243 STRESS PROBLEM N FDA C91801 Medical Device Evaluation Results Terminology FDA CDRH C92041 135 DEGRADATION PROBLEM Device problems that occur when the device becomes worn, weakened, corroded, or broken down due to processes such as aging, permeation, and corrosion. C92078 174 MATERIALS AND CHEMISTRY PROBLEM N FDA C91801 Medical Device Evaluation Results Terminology FDA CDRH C92042 110 DESIGN ERROR The device or component had faulty (incomplete or incorrect) software design. C92113 104 SOFTWARE PROBLEM N FDA C91801 Medical Device Evaluation Results Terminology FDA CDRH C92043 646 DUST OR DIRT PROBLEM A device that experienced problems due to dust or dirt that has adhered to its surfaces. C92051 331 ENVIRONMENT PROBLEM N FDA C91801 Medical Device Evaluation Results Terminology FDA CDRH C92044 650 CURRENT LEAKAGE PROBLEM A device that experiences problems related to small currents which may cause electric shock. Leakage current is the current that flows through the protective ground conductor to ground. In the absence of a grounding connection, it is the current that could flow from any conductive part or the surface of non-conductive parts to ground if a conductive path was available (such as a human body). There are always extraneous currents flowing in the safety ground conductor. C92097 3227 POWER SOURCE PROBLEM N FDA C91801 Medical Device Evaluation Results Terminology FDA CDRH C92045 120 ELECTRICAL PROBLEM C54029 3249 EVALUATION RESULT N FDA C91801 Medical Device Evaluation Results Terminology FDA CDRH C92046 197 ELECTROMAGNETIC COMPATIBILITY PROBLEM A device-to-device or device-environment problem resulting from electromagnetic disturbances C54029 3249 EVALUATION RESULT N FDA C91801 Medical Device Evaluation Results Terminology FDA CDRH C92047 648 ELECTROSTATIC DISCHARGE A device that experienced problems due to sudden and momentary bursts of electrical current flowing between 2 objects at different electrical potentials. C92046 197 ELECTROMAGNETIC COMPATIBILITY PROBLEM N FDA C91801 Medical Device Evaluation Results Terminology FDA CDRH C92048 133 END OF LIFE PROBLEM Device problems that occur from its reaching the end of its useful life. C92088 114 OPERATIONAL PROBLEM N FDA C91801 Medical Device Evaluation Results Terminology FDA CDRH C92049 3212 ENDOTOXIN CONTAMINATION The undesirable presence of toxins associated with certain bacteria (e.g. gram negative bacteria). C92054 142 CONTAMINATION BY FOREIGN MATERIAL N FDA C91801 Medical Device Evaluation Results Terminology FDA CDRH C92050 131 ENERGY STORAGE SYSTEM PROBLEM Device 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. An accumulator is an apparatus by means of which energy can be stored, such as a rechargeable battery or a hydraulic accumulator. Such devices may be electrical, fluidic or mechanical and are sometimes used to convert a small continuous power source into a short surge of energy or vice versa. Other examples of accumulators include capacitors, compulsators, steam accumulator, wave energy machines, pumped-storage hydroelectric plants. C92097 3227 POWER SOURCE PROBLEM N FDA C91801 Medical Device Evaluation Results Terminology FDA CDRH C92051 331 ENVIRONMENT PROBLEM A device problem that occurred due to factors within the environment e.g. dust, dirt, humidity, temperature. C54029 3249 EVALUATION RESULT N FDA C91801 Medical Device Evaluation Results Terminology FDA CDRH C92052 3250 FAILURE TO CALIBRATE A device that cannot calibrate (establish the relationship between a measuring device and the units of measure) to ensure accurate readings. C92088 114 OPERATIONAL PROBLEM N FDA C91801 Medical Device Evaluation Results Terminology FDA CDRH C92053 3251 FATIGUE PROBLEM Device problems due to the weakening or breakdown of its material when subjected to stress or a series of repeated stresses. C92120 3243 STRESS PROBLEM N FDA C91801 Medical Device Evaluation Results Terminology FDA CDRH C92054 142 CONTAMINATION BY FOREIGN MATERIAL The undesirable presence of any substance that does not belong either on the device or in an organism and may lead to infection or fever. C92030 3204 BIOLOGICAL PROBLEM N FDA C91801 Medical Device Evaluation Results Terminology FDA CDRH C92055 3252 FRACTURE PROBLEM Device problems caused by the separation of a component, object, or material into two or more pieces including shear. C92120 3243 STRESS PROBLEM N FDA C91801 Medical Device Evaluation Results Terminology FDA CDRH C92056 3253 FRICTION PROBLEM A device problem caused by its surface coming in contact with another surface or fluid. C92079 180 MECHANICAL PROBLEM N FDA C91801 Medical Device Evaluation Results Terminology FDA CDRH C92057 3254 GENOTOXIC PROBLEM The device's ability to cause damage to genetic material (e.g., leading malignant tumors). (See ISO 10993) C92030 3204 BIOLOGICAL PROBLEM N FDA C91801 Medical Device Evaluation Results Terminology FDA CDRH C92058 323 GRADIENT INDUCED FIELD PROBLEM Device problems that result from the gradient induced fields generated during radiologic procedures e.g. magnetic resonance imaging. C92102 3230 RADIOGRAPHIC PROBLEM N FDA C91801 Medical Device Evaluation Results Terminology FDA CDRH C92059 211 HARDWARE TIMING PROBLEM A problem that results from improper sequencing or activation of electronic components. C92045 120 ELECTRICAL PROBLEM N FDA C91801 Medical Device Evaluation Results Terminology FDA CDRH C92060 3255 HEMATOLOGIC PROBLEM The device affects or impacts the blood or its components. (See ISO 10993) C92030 3204 BIOLOGICAL PROBLEM N FDA C91801 Medical Device Evaluation Results Terminology FDA CDRH C92061 332 IMPROPER HUMIDITY A device that malfunctions as the result of exposure to undesirable levels of humidity C92051 331 ENVIRONMENT PROBLEM N FDA C91801 Medical Device Evaluation Results Terminology FDA CDRH C92062 3256 IMAGE ARTIFACT The unacceptable distortion of an image due to signal loss that may occur during a radiologic procedure such as magnetic resonance imaging. C92102 3230 RADIOGRAPHIC PROBLEM N FDA C91801 Medical Device Evaluation Results Terminology FDA CDRH C92063 3257 IMPEDANCE PROBLEM A device that experienced problems due to insufficient or excessive resistance to AC current flow either by the device or circuit. C92045 120 ELECTRICAL PROBLEM N FDA C91801 Medical Device Evaluation Results Terminology FDA CDRH C92064 3258 IMPROPER COMPOSITION/CONCENTRATION Device 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 202 IMPROPER MATERIAL N FDA C91801 Medical Device Evaluation Results Terminology FDA CDRH C92065 202 IMPROPER MATERIAL Device problems that occur due to the presence of a material that should not be present or part of the device. C92078 174 MATERIALS AND CHEMISTRY PROBLEM N FDA C91801 Medical Device Evaluation Results Terminology FDA CDRH C92066 102 INCOMPATIBLE COMPONENT A device that malfunctions due to a component(s) that does not operate correctly and according to the device's specifications. C92070 3213 INTEROPERABILITY PROBLEM N FDA C91801 Medical Device Evaluation Results Terminology FDA CDRH C92067 3201 INSTALLATION PROBLEM A device that malfunctions because it was incorrectly installed, set-up, or configured (e.g., misconfiguration of an automatic defibrillator to semi-automatic leading to failure) C92076 170 MANUFACTURING PROCESS PROBLEM N FDA C91801 Medical Device Evaluation Results Terminology FDA CDRH C92068 144 INSULATION PROBLEM A device that has inadequate or incorrect insulation material. C92045 120 ELECTRICAL PROBLEM N FDA C91801 Medical Device Evaluation Results Terminology FDA CDRH C92069 113 INTERFACE DESIGN ERROR The device software was found to contain errors in the user interface (including usability problems) or the interfaces with other systems. C92042 110 DESIGN ERROR N FDA C91801 Medical Device Evaluation Results Terminology FDA CDRH C92070 3213 INTEROPERABILITY PROBLEM A problem with the mechanical, electrical, or communication interface between two or more separate devices or components. C54029 3249 EVALUATION RESULT N FDA C91801 Medical Device Evaluation Results Terminology FDA CDRH C92071 150 LABELING PROBLEM Insufficient, inadequate, or incorrect information provided on a device's label or documentation regarding e.g. as the intended use, directions for use, and characteristics of the device. C54029 3249 EVALUATION RESULT N FDA C91801 Medical Device Evaluation Results Terminology FDA CDRH C92072 610 LOSS OF POWER A device that experienced problems due to a loss in the power supply. C92097 3227 POWER SOURCE PROBLEM N FDA C91801 Medical Device Evaluation Results Terminology FDA CDRH C92073 145 LUBRICATION PROBLEM A device problem 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 180 MECHANICAL PROBLEM N FDA C91801 Medical Device Evaluation Results Terminology FDA CDRH C92074 3215 MAGNETICALLY-INDUCED TORQUE Problems due to excessive torque created by the application of magnetic fields. C92102 3230 RADIOGRAPHIC PROBLEM N FDA C91801 Medical Device Evaluation Results Terminology FDA CDRH C92075 115 MAINTENANCE PROBLEM A device malfunction or problem that occurs because the device was not properly maintained according to the instructions (e.g., maintenance may be performed by user facility, distributor, or service provider). C92076 170 MANUFACTURING PROCESS PROBLEM N FDA C91801 Medical Device Evaluation Results Terminology FDA CDRH C92076 170 MANUFACTURING PROCESS PROBLEM Problems with a device that can be traced back to a problem in the manufacturing and/or production process. C54029 3249 EVALUATION RESULT N FDA C91801 Medical Device Evaluation Results Terminology FDA CDRH C92077 3216 MATERIAL OR MATERIAL LEACHATE PYROGENIC PROBLEM The undesirable presence of pyrogens or fever-producing organisms caused by materials that permeate through the device. C92054 142 CONTAMINATION BY FOREIGN MATERIAL N FDA C91801 Medical Device Evaluation Results Terminology FDA CDRH C92078 174 MATERIALS AND CHEMISTRY PROBLEM Device malfunctions that arise from problems with its components or materials or how its materials or components react to other elements either within the device or within the environment. C54029 3249 EVALUATION RESULT N FDA C91801 Medical Device Evaluation Results Terminology FDA CDRH C92079 180 MECHANICAL PROBLEM Device problems that result from internal or external forces including fluids, other objects, or environmental or physiologic influences. C54029 3249 EVALUATION RESULT N FDA C91801 Medical Device Evaluation Results Terminology FDA CDRH C92080 3217 MECHANICAL SHOCK PROBLEM Device problems caused by the sudden violent blow or collision to the whole device (e.g. by dropping). C92120 3243 STRESS PROBLEM N FDA C91801 Medical Device Evaluation Results Terminology FDA CDRH C92081 3218 MICROBIAL CONTAMINATION The undesirable presence of microorganisms or microbes such as bacteria and fungi (yeasts and molds). C92054 142 CONTAMINATION BY FOREIGN MATERIAL N FDA C91801 Medical Device Evaluation Results Terminology FDA CDRH C92082 3220 MUTAGENIC PROBLEM The device's ability to change genetic information (usually DNA) of an organism and thus increasing the frequency of mutations. C92057 3254 GENOTOXIC PROBLEM N FDA C91801 Medical Device Evaluation Results Terminology FDA CDRH C92083 213 NO FAILURE DETECTED The device either functioned as designed or a failure was not found. C54029 3249 EVALUATION RESULT N FDA C91801 Medical Device Evaluation Results Terminology FDA CDRH C92084 3221 NO RESULTS AVAILABLE SINCE NO EVALUATION PERFORMED For use when no methods were performed and therefore no results will be obtained. C54029 3249 EVALUATION RESULT N FDA C91801 Medical Device Evaluation Results Terminology FDA CDRH C92085 3222 NON-FUNCTIONAL DEFECT The device software contained software errors that did not impact its operation. C92042 110 DESIGN ERROR N FDA C91801 Medical Device Evaluation Results Terminology FDA CDRH C92086 3223 NON-TERMINATING CODE The device software failed to provide a safe exit from a repeating code segment. C92115 3240 SOFTWARE RUNTIME ERROR N FDA C91801 Medical Device Evaluation Results Terminology FDA CDRH C92087 122 OPEN CIRCUIT A device with an electrical circuit that does not conduct current because a switch is open, a wire is broken, etc. C92045 120 ELECTRICAL PROBLEM N FDA C91801 Medical Device Evaluation Results Terminology FDA CDRH C92088 114 OPERATIONAL PROBLEM Device problems that occur during the performance, use, or functioning of the device. C54029 3249 EVALUATION RESULT N FDA C91801 Medical Device Evaluation Results Terminology FDA CDRH C92089 3224 OPTICAL PROBLEM C54029 3249 EVALUATION RESULT N FDA C91801 Medical Device Evaluation Results Terminology FDA CDRH C92090 196 OPTICAL TRANSMISSION PROBLEM A problem with the device's ability to pass light energy. C92089 3224 OPTICAL PROBLEM N FDA C91801 Medical Device Evaluation Results Terminology FDA CDRH C92091 3225 OUT-OF-BOUNDS ERROR The device software attempted to write data outside the allowed memory location. C92115 3240 SOFTWARE RUNTIME ERROR N FDA C91801 Medical Device Evaluation Results Terminology FDA CDRH C92092 160 PACKAGE INSERT PROBLEM Device packaging that is missing the insert or that contains an incorrect or inadequate insert (e.g. an insert with either the incorrect information or insufficient information). C92094 111 PACKAGING PROBLEM N FDA C91801 Medical Device Evaluation Results Terminology FDA CDRH C92093 171 PACKAGING COMPROMISED Device packaging that has been opened purposefully or inadvertently thus exposing the device to the outside environment and rendering it unsterile or unclean (e.g. a broken seal or ripped or torn packaging). C92094 111 PACKAGING PROBLEM N FDA C91801 Medical Device Evaluation Results Terminology FDA CDRH C92094 111 PACKAGING PROBLEM Reports related to the outer, protective wrapping of a device (e.g. a broken seal or ripping (compromised), lack of correct contents). C92076 170 MANUFACTURING PROCESS PROBLEM N FDA C91801 Medical Device Evaluation Results Terminology FDA CDRH C92095 3226 PLATELET ACTIVATION PROBLEM A device that affects the body's ability to activate platelets which are essential to stop bleeding and repair the tissue. Platelets also play a key role in the development of acute coronary syndromes and contribute to cerebrovascular events. C92060 3255 HEMATOLOGIC PROBLEM N FDA C91801 Medical Device Evaluation Results Terminology FDA CDRH C92096 659 POWER FLUCTUATION The device or component failed due to fluctuations within the power supply (e.g. transient power, power spike, power dip, or power sequencing). C92097 3227 POWER SOURCE PROBLEM N FDA C91801 Medical Device Evaluation Results Terminology FDA CDRH C92097 3227 POWER SOURCE PROBLEM Problems that are related to the device that provides power. C92045 120 ELECTRICAL PROBLEM N FDA C91801 Medical Device Evaluation Results Terminology FDA CDRH C92098 3228 PROTECTIVE SYSTEM FAILURE A device that fails when the system designed to ensure its safe operation fails. C92045 120 ELECTRICAL PROBLEM N FDA C91801 Medical Device Evaluation Results Terminology FDA CDRH C92099 143 QUALITY CONTROL PROBLEM Device problems that result from the failure to maintain or establish techniques for controlling and verifying the product specifications identified by the manufacturer. C92076 170 MANUFACTURING PROCESS PROBLEM N FDA C91801 Medical Device Evaluation Results Terminology FDA CDRH C92100 3229 RADIOFREQUENCY INDUCED OVERHEATING An unacceptable or unexpected RF-induced temperature rise in the vicinity of a medical device or body part (usually caused by a closed current loop). C92102 3230 RADIOGRAPHIC PROBLEM N FDA C91801 Medical Device Evaluation Results Terminology FDA CDRH C92101 611 RADIOFREQUENCY INTERFERENCE (RFI) A device that experienced 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 197 ELECTROMAGNETIC COMPATIBILITY PROBLEM N FDA C91801 Medical Device Evaluation Results Terminology FDA CDRH C92102 3230 RADIOGRAPHIC PROBLEM Problems that occur with devices used for radiographic or imaging procedures e.g. CT scanners, magnetic resonance imaging, etc. C92045 120 ELECTRICAL PROBLEM N FDA C91801 Medical Device Evaluation Results Terminology FDA CDRH C92103 3231 REACTIVITY PROBLEM A device problem related to how the materials react inappropriately (e.g. over-react or under-react). C92078 174 MATERIALS AND CHEMISTRY PROBLEM N FDA C91801 Medical Device Evaluation Results Terminology FDA CDRH C92104 3232 REPRODUCTIVE TOXICITY PROBLEM The device or component affects reproductive function, embryo development (teratogenicity), and prenatal and early postnatal development. (ISO 10993 part 3) C92030 3204 BIOLOGICAL PROBLEM N FDA C91801 Medical Device Evaluation Results Terminology FDA CDRH C92105 3235 RUNTIME MEMORY ACCESS ERROR The device software attempted to access an illegal or corrupted memory location. C92115 3240 SOFTWARE RUNTIME ERROR N FDA C91801 Medical Device Evaluation Results Terminology FDA CDRH C92106 192 SHELF LIFE EXCEEDED A device that has exceeded the period of time recommended by the manufacturer for storing the device without a degradation in quality. C92088 114 OPERATIONAL PROBLEM N FDA C91801 Medical Device Evaluation Results Terminology FDA CDRH C92107 3236 SHIPPING PROBLEM Device problems traced back to how the device was shipped (some examples may include the temperature of the shipping compartment or the method of transportation). C92076 170 MANUFACTURING PROCESS PROBLEM N FDA C91801 Medical Device Evaluation Results Terminology FDA CDRH C92108 121 SHORT CIRCUIT A device experiencing 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 120 ELECTRICAL PROBLEM N FDA C91801 Medical Device Evaluation Results Terminology FDA CDRH C92109 3237 SIGNAL LOSS Problems with a device due the loss or weakening of a signal or signals. C92045 120 ELECTRICAL PROBLEM N FDA C91801 Medical Device Evaluation Results Terminology FDA CDRH C92110 3210 DEADLOCK The device software locked up because two or more processes were waiting for each other to finish. C92115 3240 SOFTWARE RUNTIME ERROR N FDA C91801 Medical Device Evaluation Results Terminology FDA CDRH C92111 3238 SOFTWARE INSTALLATION PROBLEM The device software was not installed as per the specifications or failed to properly install. C92113 104 SOFTWARE PROBLEM N FDA C91801 Medical Device Evaluation Results Terminology FDA CDRH C92112 3214 LIVELOCK The device software failed because two or more processes compete with each other such that the program does not perform as intended. C92115 3240 SOFTWARE RUNTIME ERROR N FDA C91801 Medical Device Evaluation Results Terminology FDA CDRH C92113 104 SOFTWARE PROBLEM C54029 3249 EVALUATION RESULT N FDA C91801 Medical Device Evaluation Results Terminology FDA CDRH C92114 3239 SOFTWARE REQUIREMENT ERROR The software requirements for the device are either incomplete, inadequate, or in conflict. C92113 104 SOFTWARE PROBLEM N FDA C91801 Medical Device Evaluation Results Terminology FDA CDRH C92115 3240 SOFTWARE RUNTIME ERROR The device software failed during operation as a result of a coding error. C92113 104 SOFTWARE PROBLEM N FDA C91801 Medical Device Evaluation Results Terminology FDA CDRH C92116 3241 SOFTWARE SECURITY VULNERABILITY The device software failed to provide adequate authorization, access control, and accountability features. C92113 104 SOFTWARE PROBLEM N FDA C91801 Medical Device Evaluation Results Terminology FDA CDRH C92117 634 SOFTWARE TIMING PROBLEM A device problem that results from the incorrect sequencing or activation of software modules. C92042 110 DESIGN ERROR N FDA C91801 Medical Device Evaluation Results Terminology FDA CDRH C92118 3242 STIFFNESS PROBLEM A device problem that occurred when its material is either too flexible/pliable or inflexible/rigid when in contact by an applied force. C92079 180 MECHANICAL PROBLEM N FDA C91801 Medical Device Evaluation Results Terminology FDA CDRH C92119 193 STORAGE PROBLEM Device problems that result from storing the device in an uncontrolled or improper environment (e.g., moisture sensitive devices stored in a humid environment). C92076 170 MANUFACTURING PROCESS PROBLEM N FDA C91801 Medical Device Evaluation Results Terminology FDA CDRH C92120 3243 STRESS PROBLEM Device 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 180 MECHANICAL PROBLEM N FDA C91801 Medical Device Evaluation Results Terminology FDA CDRH C92121 3219 MOLECULAR STRUCTURE PROBLEM Device 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 202 IMPROPER MATERIAL N FDA C91801 Medical Device Evaluation Results Terminology FDA CDRH C92122 642 THERMAL PROBLEM Device problems related to the temperature of the component, device or use environment. C54029 3249 EVALUATION RESULT N FDA C91801 Medical Device Evaluation Results Terminology FDA CDRH C92123 3244 THROMBOSIS ACTIVATION PROBLEM The device or component caused the formation of a stationary blood clot along the walls of a blood vessel resulting in an obstruction. The obstruction can occur by several means e.g. blood clotting problems (coagulation), clots from other areas of the body (emboli), or caused by device materials or reactions to drugs or the removal of drugs. C92060 3255 HEMATOLOGIC PROBLEM N FDA C91801 Medical Device Evaluation Results Terminology FDA CDRH C92124 176 TOLERANCE STACK-UP Device problems that result from a combination of specification variances of the components. C92088 114 OPERATIONAL PROBLEM N FDA C91801 Medical Device Evaluation Results Terminology FDA CDRH C92125 3245 TYPE MISMATCH The device software assigned one type of value into a variable of another type. C92115 3240 SOFTWARE RUNTIME ERROR N FDA C91801 Medical Device Evaluation Results Terminology FDA CDRH C92126 637 UNHANDLED INTERRUPT OR EXCEPTION The device software did not correctly address abnormal execution of the code. C92115 3240 SOFTWARE RUNTIME ERROR N FDA C91801 Medical Device Evaluation Results Terminology FDA CDRH C92127 3246 UNREACHABLE CODE The device software contained code that could never be executed under any circumstance. C92115 3240 SOFTWARE RUNTIME ERROR N FDA C91801 Medical Device Evaluation Results Terminology FDA CDRH C92128 3247 UNUSED DEVICE RETURNED IN STERILE PACKAGING An unused device that has been returned in packaging that remains intact. C92094 111 PACKAGING PROBLEM N FDA C91801 Medical Device Evaluation Results Terminology FDA CDRH C92129 649 VIBRATION PROBLEM Device problems caused by the constant rhythmic motion of the device, a device's component, or something in the environment to which the device is exposed. C92120 3243 STRESS PROBLEM N FDA C91801 Medical Device Evaluation Results Terminology FDA CDRH C92130 140 WEAR PROBLEM Device problems due to the premature or expected erosion of its material by use, deterioration, or change. C92120 3243 STRESS PROBLEM N FDA C91801 Medical Device Evaluation Results Terminology FDA CDRH C92131 608 WIRED COMMUNICATION PROBLEM Communications problems between devices within a wired system. C92034 628 COMMUNICATIONS PROBLEM N FDA C91801 Medical Device Evaluation Results Terminology FDA CDRH C92132 3248 WIRELESS COMMUNICATION PROBLEM Communications problems between devices within a wireless system. C92034 628 COMMUNICATIONS PROBLEM N FDA C91801 Medical Device Evaluation Results Terminology FDA CDRH C92133 3259 IMPROPER PHYSICAL STRUCTURE A device problem related to the incorrect or inadequate arrangement of the parts, components, elements, or materials. C92065 202 IMPROPER MATERIAL N FDA C91801 Medical Device Evaluation Results Terminology FDA CDRH C92134 651 IMPROPER TEMPERATURE A device that malfunctions as the result of exposure to the temperatures that are outside of those in the device's specifications. C92051 331 ENVIRONMENT PROBLEM N FDA C91801 Medical Device Evaluation Results Terminology FDA CDRH C92135 3260 INADEQUATE IMMUNITY A device that lacks adequate immunity or capabilities to resist electromagnetic interference (EMI). C92046 197 ELECTROMAGNETIC COMPATIBILITY PROBLEM N FDA C91801 Medical Device Evaluation Results Terminology FDA CDRH C92136 156 INADEQUATE LABELING CONTENT Invalid, incorrect, or inappropriate information on the labels (not including instructions for use) e.g. mislabeled contents or device labeling characteristics or package contents. C92071 150 LABELING PROBLEM N FDA C91801 Medical Device Evaluation Results Terminology FDA CDRH C92137 154 INADEQUATE INSTRUCTIONS FOR USE Insufficient information on the labels or in the manuals related to a device's instructions for use e.g. steps that are difficult to follow or that are missing. C92071 150 LABELING PROBLEM N FDA C91801 Medical Device Evaluation Results Terminology FDA CDRH C92138 195 INAPPROPRIATE OR INSUFFICIENT STERILIZATION Inadequate sterilization of a device possibly resulting in the presence of microorganisms or other contaminants on the device. C92033 201 CLEANING, DISINFECTING AND STERILIZATION PROBLEM N FDA C91801 Medical Device Evaluation Results Terminology FDA CDRH C92139 203 INCOMPATIBLE MATERIAL Device problems related to materials that can co-exist simultaneously as part of the device. C92078 174 MATERIALS AND CHEMISTRY PROBLEM N FDA C91801 Medical Device Evaluation Results Terminology FDA CDRH C92140 3199 INCOMPLETE DEVICE RETURNED The device that was returned was not complete and/or is missing parts or components. C54029 3249 EVALUATION RESULT N FDA C91801 Medical Device Evaluation Results Terminology FDA CDRH C92141 3200 INCORRECT DATA DEFINITION The device software was found to contain errors in specifying or manipulating data items. C92042 110 DESIGN ERROR N FDA C91801 Medical Device Evaluation Results Terminology FDA CDRH C92142 618 INCORRECT ALGORITHM The device software was found to implement an incorrect sequence of steps for a specific computation. C92042 110 DESIGN ERROR N FDA C91801 Medical Device Evaluation Results Terminology FDA CDRH C92143 3233 RESULTS PENDING COMPLETION OF EVALUATION For use when the evaluation is still in progress. C54029 3249 EVALUATION RESULT N FDA C91801 Medical Device Evaluation Results Terminology FDA CDRH C92144 3234 REUSED DEVICE NOT CLEANED A device that has been used more than once without being cleaned according to the device's cleaning instructions. C92033 201 CLEANING, DISINFECTING AND STERILIZATION PROBLEM N FDA C91802 Medical Device Evaluation Conclusions Terminology FDA CDRH C54030 17 EVALUATION CONCLUSION C62596 N FDA C91802 Medical Device Evaluation Conclusions Terminology FDA CDRH C91867 10 CANNOT COMPLETE INVESTIGATION, INCOMPLETE DEVICE RETURNED C91894 67 UNABLE TO CONFIRM COMPLAINT N FDA C91802 Medical Device Evaluation Conclusions Terminology FDA CDRH C91868 11 CONCLUSION NOT YET AVAILABLE-EVALUATION IN PROGRESS The device is undergoing an evaluation but has not yet been completed. C54030 17 EVALUATION CONCLUSION N FDA C91802 Medical Device Evaluation Conclusions Terminology FDA CDRH C91869 12 DESIGN DEFICIENCY The device problem was traced back to the design specifications (e.g. in the requirements, testing processes, hazard analysis, implementation strategy). C91885 25 QUALITY SYSTEM DEFICIENCY N FDA C91802 Medical Device Evaluation Conclusions Terminology FDA CDRH C91870 13 DEVICE DIFFICULT TO OPERATE Device problems including set-up, operation, and disassembly of equipment. C91874 19 HUMAN FACTORS ISSUE N FDA C91802 Medical Device Evaluation Conclusions Terminology FDA CDRH C91871 70 DEVICE DISCARDED BY USER, UNABLE TO FOLLOW-UP C91894 67 UNABLE TO CONFIRM COMPLAINT N FDA C91802 Medical Device Evaluation Conclusions Terminology FDA CDRH C91872 50 DEVICE FAILURE RELATED TO PATIENT CONDITION A device problem that occurred in part or in total related to the patient's physiology. C91874 19 HUMAN FACTORS ISSUE N FDA C91802 Medical Device Evaluation Conclusions Terminology FDA CDRH C91873 18 FAILURE TO FOLLOW INSTRUCTIONS A device problem related to the user not following the manufacturer's instructions. C91874 19 HUMAN FACTORS ISSUE N FDA C91802 Medical Device Evaluation Conclusions Terminology FDA CDRH C91874 19 HUMAN FACTORS ISSUE C54030 17 EVALUATION CONCLUSION N FDA C91802 Medical Device Evaluation Conclusions Terminology FDA CDRH C91875 20 INCONCLUSIVE-INVESTIGATION IN PROGRESS C91894 67 UNABLE TO CONFIRM COMPLAINT N FDA C91802 Medical Device Evaluation Conclusions Terminology FDA CDRH C91876 14 DEVICE INCORRECTLY PREPARED FOR USE OR MODIFIED A device that is incorrectly modified or prepared for use by distributor, service provider, or user facility. C91874 19 HUMAN FACTORS ISSUE N FDA C91802 Medical Device Evaluation Conclusions Terminology FDA CDRH C91877 21 INFRASTRUCTURE FAILURE Device problems related to problems with the underlying framework, systems, and processes of an organization (e.g. as building power supply, network, oxygen systems). C54030 17 EVALUATION CONCLUSION N FDA C91802 Medical Device Evaluation Conclusions Terminology FDA CDRH C91878 22 KNOWN INHERENT RISK OF PROCEDURE Device problems known and documented in the labeling (including both short or long term known complications or adverse reactions). C54030 17 EVALUATION CONCLUSION N FDA C91802 Medical Device Evaluation Conclusions Terminology FDA CDRH C91879 57 LABELING DEFICIENCY Device problems that occur as the result of problems with the labeling (including package inserts, instruction manuals, instructions for use). C54030 17 EVALUATION CONCLUSION N FDA C91802 Medical Device Evaluation Conclusions Terminology FDA CDRH C91880 51 MAINTENANCE DEFICIENCY Device problems that result from improper routine or preventative maintenance. C91885 25 QUALITY SYSTEM DEFICIENCY N FDA C91802 Medical Device Evaluation Conclusions Terminology FDA CDRH C91881 23 MANUFACTURING DEFICIENCY The device problem was traced back to the manufacture of the device as opposed to systems used to control the manufacture of the device (quality system). Examples include problems with construction or assembly. C91885 25 QUALITY SYSTEM DEFICIENCY N FDA C91802 Medical Device Evaluation Conclusions Terminology FDA CDRH C91882 15 DEVICE NOT MANUFACTURED BY REPORTING FIRM C91894 67 UNABLE TO CONFIRM COMPLAINT N FDA C91802 Medical Device Evaluation Conclusions Terminology FDA CDRH C91883 92 DEVICE NOT RETURNED C91894 67 UNABLE TO CONFIRM COMPLAINT N FDA C91802 Medical Device Evaluation Conclusions Terminology FDA CDRH C91884 77 OPERATIONAL CONTEXT CAUSED OR CONTRIBUTED TO EVENT A device problem related to the operator's technique or use environment. C91874 19 HUMAN FACTORS ISSUE N FDA C91802 Medical Device Evaluation Conclusions Terminology FDA CDRH C91885 25 QUALITY SYSTEM DEFICIENCY A defect in the processes or systems used in the design and manufacture of the device. Examples include problems within the change control, production, or quality control processes. C54030 17 EVALUATION CONCLUSION N FDA C91802 Medical Device Evaluation Conclusions Terminology FDA CDRH C91886 94 DEVICE RECEIVED IN CONDITION MAKING EVALUATION IMPOSSIBLE C91894 67 UNABLE TO CONFIRM COMPLAINT N FDA C91802 Medical Device Evaluation Conclusions Terminology FDA CDRH C91887 16 DEVICE RECEIVED UNUSED IN ORIGINAL PACKAGE C91894 67 UNABLE TO CONFIRM COMPLAINT N FDA C91802 Medical Device Evaluation Conclusions Terminology FDA CDRH C91888 63 DEVICE REPAIRED AND RETURNED The device was repaired and returned to the user (reporter) following a reported device problem. C91885 25 QUALITY SYSTEM DEFICIENCY N FDA C91802 Medical Device Evaluation Conclusions Terminology FDA CDRH C91889 27 TRAINING DEFICIENCY A device problem related to inadequate training. C54030 17 EVALUATION CONCLUSION N FDA C91802 Medical Device Evaluation Conclusions Terminology FDA CDRH C91890 71 NO FAILURE DETECTED, DEVICE OPERATED WITHIN SPECIFICATION C91894 67 UNABLE TO CONFIRM COMPLAINT N FDA C91802 Medical Device Evaluation Conclusions Terminology FDA CDRH C91891 75 NO FAILURE DETECTED, DEVICE OUT OF SPECIFICATION C91894 67 UNABLE TO CONFIRM COMPLAINT N FDA C91802 Medical Device Evaluation Conclusions Terminology FDA CDRH C91892 24 OFF-LABEL, UNAPPROVED, OR CONTRAINDICATED USE Device problems related to its use during an unapproved procedure, in an unapproved patient, or for which it is contraindicated, or not listed on the label. C54030 17 EVALUATION CONCLUSION N FDA C91802 Medical Device Evaluation Conclusions Terminology FDA CDRH C91893 26 REUSE OF SINGLE USE DEVICE Device problems related to the use of a device more than once when it is designed for only one use. C54030 17 EVALUATION CONCLUSION N FDA C91802 Medical Device Evaluation Conclusions Terminology FDA CDRH C91894 67 UNABLE TO CONFIRM COMPLAINT The device complaint or problem cannot be confirmed. If possible, choose a more specific reason from among the terms listed in this branch of the hierarchy. C54030 17 EVALUATION CONCLUSION N FDA C91802 Medical Device Evaluation Conclusions Terminology FDA CDRH C91895 61 USE ERROR CAUSED OR CONTRIBUTED TO EVENT The interaction between the device and the user caused or contributed to the error. This includes inappropriate use of the device or failure to appropriately maintain the device. C91874 19 HUMAN FACTORS ISSUE