C FDA C54450 Patient Problem Codes FDA CDRH C48660 3189 NOT APPLICABLE If a value for test has to be provided, but has no given criteria (e.g., the result is for "report only" or "monitoring"). Determination of a value is not relevant in the current context. C48655 3192 MISSING VALUE REASON D FDA C54450 Patient Problem Codes FDA CDRH C50477 1760 CANCER, OTHER C9305 3262 CANCER C FDA C54451 Medical Device Problem Codes FDA CDRH C48660 3189 NOT APPLICABLE If a value for test has to be provided, but has no given criteria (e.g., the result is for "report only" or "monitoring"). Determination of a value is not relevant in the current context. C48655 3192 MISSING VALUE REASON C FDA C54451 Medical Device Problem Codes FDA CDRH C50433 2904 DELAMINATION Issue associated with peeling of composite materials. Occurs when layers are separated as a result of continuous stress or impact. Results in loss of mechanical toughness. C62878 1454 PEELED C FDA C54451 Medical Device Problem Codes FDA CDRH C62858 1508 THERAPY DELIVERED TO INCORRECT BODY AREA Issue associated with the device causing unintended therapeutic action to an area of the body other than the intended area. C62955 2913 DEVICE OPERATES DIFFERENTLY THAN EXPECTED C FDA C54451 Medical Device Problem Codes FDA CDRH C62931 1525 DEVICE REMAINS ACTIVATED Issue associated with the device continuing to be in an active state after deactivation was requested. C62988 2939 FAILURE TO SHUT OFF C FDA C54451 Medical Device Problem Codes FDA CDRH C62976 2911 DEVICE MARKINGS ISSUE Issue associated with the written, printed or graphic material that is affixed to a medical device or any of its containers or wrappers or accompanying the device including verbal instructions, relating to identification, technical description, and usage which are provided by the device manufacturers. Issue can include but is not limited to this material being unclear, missing worn out, incorrect or inaccurate. C63041 2975 MANUFACTURING OR SHIPPING ISSUE ASSOCIATED WITH DEVICE C FDA C54451 Medical Device Problem Codes FDA CDRH C62988 2939 FAILURE TO SHUT OFF Issue associated with the device not powering off when a shut down was requested. C63005 2928 ELECTRONIC PROPERTY ISSUE C FDA C54451 Medical Device Problem Codes FDA CDRH C63031 2959 INAPPROPRIATE OR UNEXPECTED RESET Issue associated with the inability to appropriately perform or generate any automated setting if no specific selection has made by the users. C62852 3019 RESET ISSUE C FDA C54451 Medical Device Problem Codes FDA CDRH C63044 2575 LOW SENSING THRESHOLD SENSING THRESHOLD, LOW Issue associated with the amount of an input required by the device to detect a signal being lower than expected/desired. C63061 2293 INVALID SENSING C FDA C54451 Medical Device Problem Codes FDA CDRH C63061 2293 INVALID SENSING SENSING, INVALID Issue associated with the inaccuracy of a device designed to respond to an input (such as temperature, illumination, motion) to transmit a resulting signal that can not be used for interpretation or measurement. C63238 2917 DEVICE SENSING ISSUE C FDA C54451 Medical Device Problem Codes FDA CDRH C63078 2535 INCREASED SENSITIVITY OVERSENSING|SENSITIVITY, INCREASED Issue with the device being more sensitive to an input than intended or expected. C63061 2293 INVALID SENSING C FDA C54451 Medical Device Problem Codes FDA CDRH C63097 1442 PACING INADEQUATELY Pacing voltage or pulse width is less than desired. C63169 1439 FAILURE TO PACE OR PROPERLY PACE C FDA C54451 Medical Device Problem Codes FDA CDRH C63121 2574 HIGH SENSING THRESHOLD SENSING THRESHOLD, HIGH Issue associated with the amount of input required by the device to detect a signal being higher than expected/desired. C63061 2293 INVALID SENSING C FDA C54451 Medical Device Problem Codes FDA CDRH C63157 2536 FAILURE TO SPIKE SPIKE, FAILURE TO Failure of device to generate a correctly-shaped pacing output, for example, a waveform that is too wide. C63169 1439 FAILURE TO PACE OR PROPERLY PACE D FDA C54451 Medical Device Problem Codes FDA CDRH C63170 1542 FAILURE TO OVERRIDE RHYTHM RHYTHM, FAILURE TO OVERRIDE C63169 1439 FAILURE TO PACE OR PROPERLY PACE C FDA C54451 Medical Device Problem Codes FDA CDRH C63177 2610 FAILURE TO FIRE FIRE, FAILURE TO Issue associated with a therapy or algorithm not being delivered or executed at the expected time. C62955 2913 DEVICE OPERATES DIFFERENTLY THAN EXPECTED C FDA C54451 Medical Device Problem Codes FDA CDRH C63190 1540 FAILURE TO CONVERT RHYTHM RHYTHM, FAILURE TO CONVERT Failure of a device therapy or set of therapies to terminate the arrhythmia that the therapy is meant to terminate. C63007 1198 ELECTRICAL ISSUE C FDA C54451 Medical Device Problem Codes FDA CDRH C63253 2534 DECREASED SENSITIVITY SENSITIVITY, DECREASED|UNDERSENSING Issue with the device being less sensitive to an input than intended or expected. C63061 2293 INVALID SENSING C FDA C54451 Medical Device Problem Codes FDA CDRH C63259 3025 UNAUTHORIZED ACCESS TO COMPUTER SYSTEM Issue associated with an access that was not permitted to the computer system that may lead to modification of program, corruption of data, or and break in network security. This concept is closely associated with computer integrity which is the degree to which a system or component prevents unauthorized access to, or modification of, computer programs or data. C64348 2899 COMPUTER SYSTEM SECURITY ISSUE C FDA C54451 Medical Device Problem Codes FDA CDRH C63271 2896 COMMUNICATION OR TRANSMISSION ISSUE Issue associated with the device sending or receiving signals or data. This includes transmission among internal components of the device and other external devices to which the device is intended to communicate. C62937 3008 PHYSICAL PROPERTY ISSUE C FDA C54451 Medical Device Problem Codes FDA CDRH C63276 2895 DISINFECTION OR STERILIZATION ISSUE AT USER LOCATION Issue associated with the undesired introduction of impurities to a device, or the insufficient removal of any visible soil, foreign material or organism deposits on the external surfaces, crevices, and joints of a device by a mechanical and/or manual process intended to render the device sterile, safe for handling, and/or for further processes to decontaminate. This issue is restricted to happening at the location where the device is used as opposed to during manufacturer or shipping. C62808 2935 FACILITIES ISSUE C FDA C54451 Medical Device Problem Codes FDA CDRH C63280 2586 DELAYED CHARGE TIME CHARGE TIMES, DELAYED Issue associated with an unexpected amount of time required to charge the device as required (for example, a delay in starting charging or a longer than expected charge time). C63026 2892 CHARGING ISSUE C FDA C54451 Medical Device Problem Codes FDA CDRH C63298 1441 PACING ASYNCHRONOUSLY Issue associated with a pacing transmission process such that between any two significant instants in the same group, there is always an integral number of unit intervals. Between two significant instants located in different groups, there are not always an integral number of unit intervals. C63169 1439 FAILURE TO PACE OR PROPERLY PACE C FDA C54451 Medical Device Problem Codes FDA CDRH C64339 1496 DIFFICULT TO PROGRAM OR CALIBRATE PROGRAM, DIFFICULT TO Issue associated with the user's ability to cause device settings or actions to change to the state desired by the user. C76121 2949 HUMAN-DEVICE INTERFACE ISSUE C FDA C54451 Medical Device Problem Codes FDA CDRH C72892 3017 RADIATION OVEREXPOSURE Issue associated with excessive radiation emitted from radiological or diagnostic device. C62942 3004 OUTPUT BELOW SPECIFICATIONS A FDA C54451 Medical Device Problem Codes FDA CDRH C95875 3266 HIGH CAPTURE THRESHOLD CAPTURE THRESHOLD, HIGH Issue associated with the amount of output energy needed to cause cardiac depolarization being higher than expected/desired. C63027 2891 CAPTURING ISSUE A FDA C54451 Medical Device Problem Codes FDA CDRH C95876 3269 UNSTABLE CAPTURE THRESHOLD CAPTURE THRESHOLD, UNSTABLE Issue with the amount of output energy needed to cause cardiac depolarization being unstable. C63027 2891 CAPTURING ISSUE A FDA C54451 Medical Device Problem Codes FDA CDRH C95877 3268 NO PACING Issue associated with the device ceasing to deliver paces. C63169 1439 FAILURE TO PACE OR PROPERLY PACE A FDA C54451 Medical Device Problem Codes FDA CDRH C95878 3267 MISSING TEST RESULTS TEST RESULTS, MISSING Issue associated with the results of a test or measurement not appearing. C62829 2456 INCORRECT OR INADEQUATE TEST RESULTS A FDA C54451 Medical Device Problem Codes FDA CDRH C95879 3265 DEVICE HANDLING ISSUE User handling not in accordance with specification. C63318 1670 USE OF DEVICE ISSUE C FDA C62596 FDA Center For Devices and Radiological Health Terminology C19238 DIAGNOSTIC, THERAPEUTIC, OR RESEARCH EQUIPMENT A manufactured object that is used to perform diagnostic, therapeutic or research activities. C62596