D 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. D FDA C54451 Medical Device Problem Codes FDA CDRH C48655 3192 Missing Value Reason A specific reason explaining why a meaningful value is not available. A meaningful value answers the question posed by a Data Element Concept. In contrast, a Missing Value Reason answers the implicit question "Why is there no 'meaningful' value?", when there is none. D FDA C62596 FDA Center For Devices and Radiological Health Terminology C99179 3273 Noise, Audible Acoustic Noise|Audible Noise|Noise, Acoustic Issue associated with any unintended sound which emanates from a device (for example, squeaking from two parts rubbing together or buzzing sounds from electrical components). An unintended or unpleasant sound that emanates from a device. D 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. D FDA C54451 Medical Device Problem Codes FDA CDRH C50557 2934 Extrusion Issue associated with the unintended of projection of device component materials. D FDA C54451 Medical Device Problem Codes FDA CDRH C62804 2614 Wrinkled Wrinkled Material|Wrinkling D FDA C54451 Medical Device Problem Codes FDA CDRH C62808 2935 Facilities Issue User Facility Issue Issue associated with the physical establishment and environment in which medical devices are transported, stored, processed, serviced or used within the user facility. D FDA C54451 Medical Device Problem Codes FDA CDRH C62815 1377 Unintended Magnet Quench Magnet Quench, Unintended D FDA C54451 Medical Device Problem Codes FDA CDRH C62816 1284 Unintended Head Motion Head Motion, Unintended D FDA C54451 Medical Device Problem Codes FDA CDRH C62820 1033 Unintended Arm Motion Arm Motion, Unintended D FDA C54451 Medical Device Problem Codes FDA CDRH C62825 1659 Uncoiled D FDA C54451 Medical Device Problem Codes FDA CDRH C62829 2456 Incorrect Or Inadequate Test Results Test Results, Inaccurate D FDA C54451 Medical Device Problem Codes FDA CDRH C62832 3024 Torn Material Issue associated with comprising material(s) being pulled apart or into pieces by force, wrenching, or laceration. D FDA C54451 Medical Device Problem Codes FDA CDRH C62834 2538 Strikethrough D FDA C54451 Medical Device Problem Codes FDA CDRH C62836 1597 Sticking D FDA C54451 Medical Device Problem Codes FDA CDRH C62839 3014 Programming Issue Issue associated with the written program code or application software used to satisfy a stated need or objective for functioning of the device. These do not include issues associated with the operating system. D FDA C54451 Medical Device Problem Codes FDA CDRH C62845 3021 Sediment, Precipitate Or Deposit In Device Or Device Ingredient D FDA C54451 Medical Device Problem Codes FDA CDRH C62856 1511 Radio Signal Problem Radio Signal Problems Issue associated with the wireless transmission signal in the lowest range of the electromagnetic spectrum. D FDA C54451 Medical Device Problem Codes FDA CDRH C62867 1477 Pre Or Post-Pumping Problem Pre/Post-Pumping Problems D FDA C54451 Medical Device Problem Codes FDA CDRH C62870 2957 Inadequate Lighting Issue associated with an inappropriate level of light or illumination in the immediate environment in which the device is being used or stored. D FDA C54451 Medical Device Problem Codes FDA CDRH C62871 1306 Image Resolution Poor D FDA C54451 Medical Device Problem Codes FDA CDRH C62873 1462 Plunge D FDA C54451 Medical Device Problem Codes FDA CDRH C62875 2578 Physical Resistance Resistance, Physical D FDA C54451 Medical Device Problem Codes FDA CDRH C62896 1423 Occlusion Within Device Occlusion|Plugged Issue associated with an obstruction or blockage within any of the device components (e.g. tube, opening, pipe) that results in a restriction of flow. D FDA C54451 Medical Device Problem Codes FDA CDRH C62907 2987 Mushroomed D FDA C54451 Medical Device Problem Codes FDA CDRH C62918 1804 Metal Shedding Debris Debris, Metal Shedding D FDA C54451 Medical Device Problem Codes FDA CDRH C62924 1599 Device Stops Intermittently Issue associated with any deviation from device document specification relating to the irregular rate at which the device stops. D FDA C54451 Medical Device Problem Codes FDA CDRH C62926 1567 Shelf Life Exceeded Issue associated with the using a device after the marked or known shelf life. D FDA C54451 Medical Device Problem Codes FDA CDRH C62928 1563 Failure To Service Service, Failure To Issue associated with the lack of periodic preventive maintenance or performance assurance checks. D FDA C54451 Medical Device Problem Codes FDA CDRH C62937 3008 Physical Property Issue Device Physical Property Issue Issue associated with any deviations from specifications relating to device physical properties in terms of material integrity, mechanical, manufacturing/shipping, communication/transmission, optical, temperature, chemical, and electronic issues. D FDA C54451 Medical Device Problem Codes FDA CDRH C62944 2311 Out-Of-Box Failure D FDA C54451 Medical Device Problem Codes FDA CDRH C62954 2914 Device Operational Issue Issue associated with any deviations from specifications relating to device operations (e.g. deployment, connection, electrical, computer software, infusion/flow, output, protective-measure, and incompatibility issues). D FDA C54451 Medical Device Problem Codes FDA CDRH C62955 2913 Device Operates Differently Than Expected Issue associated with any deviations from expected performance while operating and using the device. D FDA C54451 Medical Device Problem Codes FDA CDRH C62963 2537 Split Material Split|Splitting Issue associated with a partial or full-thickness crack in the device materials. D FDA C54451 Medical Device Problem Codes FDA CDRH C62977 1379 Device Maintenance Issue Maintain, Failure To Issue associated with the servicing of a device. D FDA C54451 Medical Device Problem Codes FDA CDRH C62978 2974 Maintenance Does Not Comply To Manufacturers Recommendations Maintenance Not To Manufacturers Recommendations Issue associated with the non-compliance or non-performance to manufacturer specifications relating to device routine maintenance, i.e., periodic inspection, failure detection, repair, and care of the device to sustain or restore acceptable operating conditions. D FDA C54451 Medical Device Problem Codes FDA CDRH C62979 1663 Device Inoperable Device, Inoperable Issue associated with the device being in a nonfunctional or inoperable state and cannot be used unless the causes of the inoperability are located and fixed. D FDA C54451 Medical Device Problem Codes FDA CDRH C62996 2379 Device Issue Device Failure|Malfunction An adverse event and reportable event where a medical device may have caused or contributed to a death or serious injury. D FDA C54451 Medical Device Problem Codes FDA CDRH C62998 1216 Device Expiration Issue Expiration Date Exceeded Issue associated with the expiration date or shelf life of a product. D FDA C54451 Medical Device Problem Codes FDA CDRH C63001 1209 Energy Output To Patient Tissue Incorrect D FDA C54451 Medical Device Problem Codes FDA CDRH C63005 2928 Electronic Property Issue Issue associated with any deviations from device documented performance specifications relating to devices, circuits, or systems utilizing electrons and in association with components to convert, control and condition of electric power (alternating or direct current), and of voltage and current. D FDA C54451 Medical Device Problem Codes FDA CDRH C63008 2909 Device Disinfection Or Sterilization Issue D FDA C54451 Medical Device Problem Codes FDA CDRH C63017 2908 Device Contamination With Biological Material D FDA C54451 Medical Device Problem Codes FDA CDRH C63032 1031 Failure To Adhere Or Bond Issue associated with difficulties in attaching a device to another object including another device or device component or to a patient body part. D FDA C54451 Medical Device Problem Codes FDA CDRH C63037 1387 Device Abrasion From Instrument Or Another Object Abrasion From Instrument/Object D FDA C54451 Medical Device Problem Codes FDA CDRH C63038 2590 Device Or Device Fragments Location Unknown Device/Device Fragments, Unknown Location Of D FDA C54451 Medical Device Problem Codes FDA CDRH C63048 2584 Low Battery Battery, Low D FDA C54451 Medical Device Problem Codes FDA CDRH C63056 1370 Looping D FDA C54451 Medical Device Problem Codes FDA CDRH C63057 2972 Light Interference D FDA C54451 Medical Device Problem Codes FDA CDRH C63059 1340 Knotted Knot|Knotted Material D FDA C54451 Medical Device Problem Codes FDA CDRH C63060 1339 Kinked Kink|Kinked Material D 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. D FDA C54451 Medical Device Problem Codes FDA CDRH C63081 1495 Incorrect Software Programming Calculations Programming Calculations, Incorrect D FDA C54451 Medical Device Problem Codes FDA CDRH C63084 2962 Incorrect Device Or Component Shipped Issue associated with the delivery of an inappropriate device or device component to a user facility. D FDA C54451 Medical Device Problem Codes FDA CDRH C63095 1600 Inadequate Storage Storage Inadequate|Storage, Inadequate Issue associated with inadequate or inappropriate storage of the device, not otherwise described. D FDA C54451 Medical Device Problem Codes FDA CDRH C63098 1564 Inadequate Service Service, Inadequate Issue associated with inadequate periodic preventive maintenance or performance assurance checks. D FDA C54451 Medical Device Problem Codes FDA CDRH C63103 2955 Inaccurate Dispensing D FDA C54451 Medical Device Problem Codes FDA CDRH C63107 2309 Device Rinsing Issue Rinsing, Improper D FDA C54451 Medical Device Problem Codes FDA CDRH C63108 2953 Improper Device Output Issue associated with the inaccurate outcome of a measurement/values/data obtained from the device being different from displayed, printed, stored, or exported measurements/values/data. D FDA C54451 Medical Device Problem Codes FDA CDRH C63112 2951 Improper Alarm D FDA C54451 Medical Device Problem Codes FDA CDRH C63115 1358 Image Reversal D FDA C54451 Medical Device Problem Codes FDA CDRH C63118 2948 Human Factors Issue Issue associated with the interaction and interfacing between devices and users in terms of users' abilities, expectations, and limitations with work environments and system design. D FDA C54451 Medical Device Problem Codes FDA CDRH C63119 1298 Hot Oil Leak D FDA C54451 Medical Device Problem Codes FDA CDRH C63120 1293 Hole In Material Hole(s)|Hole Issue associated with an opening not characteristic of the normal material. D FDA C54451 Medical Device Problem Codes FDA CDRH C63134 2630 Folded Fold D FDA C54451 Medical Device Problem Codes FDA CDRH C63139 2943 Flashpoint Threshold Met Issue associated with approaching certain temperatures at which a combustible liquid ignites. D FDA C54451 Medical Device Problem Codes FDA CDRH C63145 1228 False Reading From Device Non-Compliance False Readings Issue associated with the non-compliance of the device to meet its specific performance characteristics thereby causing a false reading. D FDA C54451 Medical Device Problem Codes FDA CDRH C63150 1226 False Device Output False Output D FDA C54451 Medical Device Problem Codes FDA CDRH C63153 1105 Component Falling Component(s) Falling Issue associated with an undesirable descent of a device component due to the force of gravity, usually from a higher to a lower level, usually the ground or floor. D FDA C54451 Medical Device Problem Codes FDA CDRH C63154 2940 Failure To Unwrap Unwrap, Failure To Issue associated with problems removing the materials used to construct the cover or outer wrapping of the device. D FDA C54451 Medical Device Problem Codes FDA CDRH C63162 1001 Failure To Run On AC/DC AC/DC, Failure To Run On D FDA C54451 Medical Device Problem Codes FDA CDRH C63199 1222 Fail-Safe Design Failure Issue associated with safety features malfunctioning in such a way that results in harm to the patient or device operator. D FDA C54451 Medical Device Problem Codes FDA CDRH C63204 2931 Escape D FDA C54451 Medical Device Problem Codes FDA CDRH C63206 2963 Incorrect Error Code D FDA C54451 Medical Device Problem Codes FDA CDRH C63225 1168 Disassembly D FDA C54451 Medical Device Problem Codes FDA CDRH C63230 1467 Difficult To Position Positioning Difficulties Issue associated with the use of the device in terms of user experiencing difficulty to put device and/or device components in place, even if the operation is being performed according to labeled instructions for use. D FDA C54451 Medical Device Problem Codes FDA CDRH C63240 2916 Device Packaging Compromised Issue associated with the non-conformance to device specifications and minimum packaging requirements as the device may not be operating and functioning as intended. D FDA C54451 Medical Device Problem Codes FDA CDRH C63243 1104 Detachment Of Device Component Component(s), Detachment Of|Device Component Detached Issue associated with the unintentional separation of the device and/or its components from something to which it is connected or attached. D FDA C54451 Medical Device Problem Codes FDA CDRH C63246 2905 Delivery System Failure D FDA C54451 Medical Device Problem Codes FDA CDRH C63260 2454 Cut In Material Cut(s)|Cut D FDA C54451 Medical Device Problem Codes FDA CDRH C63273 1098 Coiled D FDA C54451 Medical Device Problem Codes FDA CDRH C63278 2894 Chemical Spillage Issue associated with unintentional pouring out or releasing of chemical substances. D FDA C54451 Medical Device Problem Codes FDA CDRH C63279 1086 Charred D FDA C54451 Medical Device Problem Codes FDA CDRH C63282 1027 Changes In Ambient Temperature In Device Environment Ambient Temperature, Changes In D FDA C54451 Medical Device Problem Codes FDA CDRH C63284 1078 Calibration Error Miscalibration D FDA C54451 Medical Device Problem Codes FDA CDRH C63292 2887 Biological Environmental Factor D FDA C54451 Medical Device Problem Codes FDA CDRH C63296 1059 Bent Bend Material|Bent Material D FDA C54451 Medical Device Problem Codes FDA CDRH C63299 2883 Aspiration Issue D FDA C54451 Medical Device Problem Codes FDA CDRH C63306 1138 Application Interface Becomes Non-Functional Or Program Exits Abnormally Crash Or Lock-Up D FDA C54451 Medical Device Problem Codes FDA CDRH C63311 1008 Air Leak Air Leak(s) D FDA C54451 Medical Device Problem Codes FDA CDRH C64334 2884 Battery Impedance Issue D FDA C54451 Medical Device Problem Codes FDA CDRH C64340 2980 Material Torqued Torqued Issue associated with a movement of forces that produces or tends to produce rotation or torsion of a material D FDA C54451 Medical Device Problem Codes FDA CDRH C72894 2977 Material Distortion Issue associated with undesired physical appearance of device material resulting from excessive stress or impact. D FDA C54451 Medical Device Problem Codes FDA CDRH C76129 2967 Issue With Displayed Error Message Issue associated with error messages that are undecipherable or which fail to prompt the user toward appropriate corrective action. A FDA C54451 Medical Device Problem Codes FDA CDRH C133645 4053 Missing Information Absence of information e.g. labeling, instruction for use. Absence of information e.g. labeling, instruction for use with medical device. A FDA C54451 Medical Device Problem Codes FDA CDRH C133644 4052 Unclear Information Problem associated with ambiguous, confused information. Medical device problem associated with ambiguous, confusing information. A FDA C54451 Medical Device Problem Codes FDA CDRH C133636 4047 Unintended compatibility Problem associated with the ability of two or more devices which are intended to be incompatible but are able to work or fit together. Problem associated with the ability of two or more medical devices which are intended to be incompatible but are able to work or fit together. A FDA C54451 Medical Device Problem Codes FDA CDRH C133635 4046 Fail-Safe Did Not Operate Problem associated with the device fail-safe mechanism, which did not function or function in a non effective way, compromising safe use of the device. Problem associated with a medical device fail-safe mechanism, which did not function or function in a non effective way, compromising safe use of the device. A FDA C54451 Medical Device Problem Codes FDA CDRH C133646 4054 Misassembly during Maintenance / Repair Problem associated with incorrect assembly of the device or constituents during maintenance or repair. Medical device problem associated with incorrect assembly of a medical device or constituents during maintenance or repair. A FDA C54451 Medical Device Problem Codes FDA CDRH C133633 4044 Difficult or Delayed Separation Problem associated with users experiencing difficulty or delay with detachment or separation of the device. Problem associated with users experiencing difficulty or delay with detachment or separation of the device. A FDA C54451 Medical Device Problem Codes FDA CDRH C133632 4043 Separation Problem Problem associated with the detachment or separation of the device. Problem associated with the detachment or separation of a medical device. A FDA C54451 Medical Device Problem Codes FDA CDRH C133603 4035 Intermittent Program or Algorithm Execution Problem associated with intermittent execution relating to program or algorithm. Problem associated with intermittent execution relating to program or algorithm of a medical device. A FDA C54451 Medical Device Problem Codes FDA CDRH C133643 4051 Inaccurate Information Problem associated with imprecise, inexact information. Medical device problem associated with imprecise, inexact information. A FDA C54451 Medical Device Problem Codes FDA CDRH C133630 4041 Incomplete or Inadequate Priming Problem associated with not adequately preparing the device. Problem associated with not adequately preparing a medical device. A FDA C54451 Medical Device Problem Codes FDA CDRH C133637 4048 Failure to Clean Adequately Problem associated with the failure of the device or operator to remove any visible soil, foreign material or organism deposits on the external surfaces, crevices, and joints of the device. Problem associated with the failure of a medical device or operator to remove any visible soil, foreign material or organism deposits on the external surfaces, crevices, and joints of the device. A FDA C54451 Medical Device Problem Codes FDA CDRH C133642 4050 Illegible Information Problem associated with information unable to be read or deciphered. Medical device problem associated with information unable to be read or deciphered. A FDA C54451 Medical Device Problem Codes FDA CDRH C133634 4045 Premature Separation Problem associated with an early and unexpected detachment or separation of the device from the system. Problem associated with an early and unexpected detachment or separation of a medical device from the system. A FDA C54451 Medical Device Problem Codes FDA CDRH C133631 4042 Activation Problem Problem associated with the activation of the device. Problem associated with the activation of a medical device. A FDA C54451 Medical Device Problem Codes FDA CDRH C133507 4007 Material Too Soft / Flexible Problem associated with any device material that results in the material's inability to maintain the desired shape or support function. Problem associated with a medical device material that results in the material's inability to maintain the desired shape or support function. A FDA C54451 Medical Device Problem Codes FDA CDRH C133559 4024 No Tactile Prompts / Feedback Problem associated with the device ceasing to provide tactile feedback. Problem associated with a medical device ceasing to provide tactile feedback. A FDA C54451 Medical Device Problem Codes FDA CDRH C133520 4016 Intermittent loss of power Problem associated with an intermittent disruption to the power to run the device. Problem associated with an intermittent disruption to the power to run a medical device. A FDA C54451 Medical Device Problem Codes FDA CDRH C133497 4002 Loosening of Implant Not Related to Bone-Ingrowth Problem associated with the loss of direct anchorage of an implanted device over time or due to an injury. Problem associated with the loss of direct anchorage of an implanted medical device over time or due to an injury. A FDA C54451 Medical Device Problem Codes FDA CDRH C133551 4023 Inappropriate Tactile Prompt / Feedback Problem with tactile feedback which does not guide a device user to the correct action. Problem with tactile feedback which does not guide a medical device user to the correct action. A FDA C54451 Medical Device Problem Codes FDA CDRH C133545 4020 Audible Prompt / Feedback Problem with any deviation from the documented specifications of the device that relate to audible feedback. e.g. voice prompts or beeps, but not safety related alarms which are covered under "Protective Measures Problem". Problem with any deviation from the documented specifications of a medical device that relates to audible feedback. A FDA C54451 Medical Device Problem Codes FDA CDRH C133513 4012 Physical Resistance / Sticking Problem associated with the lack of movement in the device due parts sticking or seizing. Problem associated with the lack of movement in a medical device due parts sticking or seizing. A FDA C54451 Medical Device Problem Codes FDA CDRH C133512 4011 Firing Problem Problem associated with the device not discharging as intended. Problem associated with a medical device not discharging as intended. A FDA C54451 Medical Device Problem Codes FDA CDRH C133527 4018 Unintended Electrical Shock The device delivers unintended electrical shock. Unintended defibrillation shock should be coded as "Inappropriate Shock" code number A071302. A medical device delivers unintended electrical shock. A FDA C54451 Medical Device Problem Codes FDA CDRH C133546 4021 No Visual Prompts / Feedback Problem associated with the device ceasing to provide visual feedback. Problem associated with a medical device ceasing to provide visual feedback. A FDA C54451 Medical Device Problem Codes FDA CDRH C133574 4029 Non Reproducible Results Device results cannot be reliably reproduced. Medical device results that cannot be reliably reproduced. A FDA C54451 Medical Device Problem Codes FDA CDRH C133505 4006 Explosion Problem associated with the violent bursting due to the sudden expansion of air, gas or fluid. Problem with a medical device associated with the violent bursting due to the sudden expansion of air, gas or fluid. A FDA C54451 Medical Device Problem Codes FDA CDRH C133571 4028 Unexpected/Unintended Radiation Output Device-emitted radiation when it was not supposed to. This applies to devices which are intended to emit radiation, and the radiation being emitted from the correct part of the device, but at an incorrect time. Use "radiation leak" if the device emits radiation which should never have been emitted, or from a location from which it should never be emitted Unintended device-emitted radiation. A FDA C54451 Medical Device Problem Codes FDA CDRH C133498 4004 Component Misassembled A device found to have one or more components incorrectly assembled when delivered to the user facility. A medical device is found to have one or more components incorrectly assembled when delivered to the user facility. A FDA C54451 Medical Device Problem Codes FDA CDRH C133509 4008 Material Split, Cut or Torn Problem associated with materials consisting the device are split, cut or torn due to external forces (e.g. wrenching or laceration) or internal forces (e.g. exceeding the tensile stress limits belonging to the materials used in the device construction). Problem associated with materials comprising a medical device are split, cut or torn due to external forces (e.g. wrenching or laceration) or internal forces (e.g. exceeding the tensile stress limits belonging to the materials used in the device construction). A FDA C54451 Medical Device Problem Codes FDA CDRH C133500 4005 Low pH pH lower than expected and / or anticipated. Medical device ingredient with pH lower than expected and / or anticipated. A FDA C54451 Medical Device Problem Codes FDA CDRH C133576 4030 Excessive Heating Inconsistent or lack of intended communication of data among internal components or with other external devices. Problem associated with a medical device which have a warming or heating function, and is producing excessive heat. A FDA C54451 Medical Device Problem Codes FDA CDRH C133496 4001 Patient Device Interaction Problem Problem related to the interaction between the patient and the device. Problem related to the interaction between the patient and a medical device. A FDA C54451 Medical Device Problem Codes FDA CDRH C133547 4022 Tactile Prompts / Feedback Problem with any deviation from the documented specifications of the device that relate to tactile feedback. e.g. device vibrational prompt. Problem with any deviation from the documented specifications of a medical device that relates to tactile feedback. e.g device vibrational prompt. A FDA C54451 Medical Device Problem Codes FDA CDRH C133516 4014 Device Fell Problem associated with the device or a component unexpectedly being dropped or moving down from an intended place. Problem associated with the device or a component unexpectedly being dropped or moving down from an intended place. A FDA C54451 Medical Device Problem Codes FDA CDRH C133517 4015 Complete Loss of power Problem associated with the lack of power to run the device. Problem associated with the lack of power to run a medical device. A FDA C54451 Medical Device Problem Codes FDA CDRH C133544 4019 Unexpected Shutdown Problem associated with the device unexpectedly powering down. Problem associated with a medical device unexpectedly powering down. A FDA C54451 Medical Device Problem Codes FDA CDRH C133514 4013 Sharp Edges The device has undesirable sharp edges which can cause harm or damage. The medical device has undesirable sharp edges which can cause harm or damage. A FDA C54451 Medical Device Problem Codes FDA CDRH C133510 4009 Ejection Problem Problems associated with the inability of or unexpected removal or separation of the device from its physical location. Problems associated with the inability of or unexpected removal or separation of a medical device from its physical location. A FDA C54451 Medical Device Problem Codes FDA CDRH C133511 4010 Failure to Eject Problem associated with the inability to remove or discharge the device from the location of use. Problem associated with the inability to remove or discharge a medical device from the location of use. A FDA C54451 Medical Device Problem Codes FDA CDRH C133523 4017 Interrogation Problem Problems associated with the device's ability to respond to signals from a system designed to interrogate its status. Problems associated with a medical device's ability to respond to signals from a system designed to interrogate its status. A FDA C54451 Medical Device Problem Codes FDA CDRH C133625 4036 Program or Algorithm Execution Failure Problem associated with the failure of a program or algorithm to execute. Sudden/unexpected interruption to a program's execution. Problem associated with the failure of a program or algorithm to execute in a medical device. A FDA C54451 Medical Device Problem Codes FDA CDRH C133722 4003 Migration Problem with all or part of an implanted or invasive device moving from its intended location within the body. Problem with all or part of an implanted or invasive medical device moving from its intended location within the body. A FDA C54451 Medical Device Problem Codes FDA CDRH C133721 4049 Misassembled During Installation Problem associated with the use of the device characterized by incorrect assembly of device components, parts or constituents. Problem associated with the use of the device characterized by incorrect assembly of device components, parts or constituents. A FDA C54451 Medical Device Problem Codes FDA CDRH C133627 4038 Intermittent Communication Failure Inconsistent or lack of intended communication of data among internal components or with other external devices. Inconsistent or lack of intended communication of data among internal components or with other external medical devices. A FDA C54451 Medical Device Problem Codes FDA CDRH C133626 4037 Incomplete or Inadequate Connection Problem associated with a partial linking of the device whereby device may appear to be connected however only a partial, intermittent or no transfer of liquid, gas, electricity, or information can be accomplished. Medical device problem associated with a partial linking of the device whereby the device may appear to be connected however only a partial, intermittent or no transfer of liquid, gas, electricity, or information can be accomplished. A FDA C54451 Medical Device Problem Codes FDA CDRH C133628 4039 Suction Failure Problem associated with the complete inability to provide suction. Problem associated with the complete inability to provide suction in a medical device. A FDA C54451 Medical Device Problem Codes FDA CDRH C133629 4040 Priming Problem Problem associated with the preparation of the device to begin pumping. Problem associated with the preparation of a medical device to begin pumping. A FDA C54451 Medical Device Problem Codes FDA CDRH C133569 4027 Radiation Output Failure Problem associated with the absence of radiation output from radiological or diagnostic devices. Problem associated with the absence of radiation output from radiological or diagnostic medical devices. A FDA C54451 Medical Device Problem Codes FDA CDRH C133561 4025 Intermittent Energy Output Problem associated with the energy output from the device being inconsistent over time. Problem associated with the energy output from a medical device being inconsistent over time. A FDA C54451 Medical Device Problem Codes FDA CDRH C133599 4034 Delayed Program or Algorithm Execution Problem associated with delayed execution relating to program or algorithm. Problem associated with a delayed execution relating to program or algorithm of a medical device. A FDA C54451 Medical Device Problem Codes FDA CDRH C133593 4033 Program or Algorithm Execution Problem Problem associated with execution problems relating to program or algorithm. Problem associated with execution problems relating to a medical device program or algorithm. A FDA C54451 Medical Device Problem Codes FDA CDRH C133562 4026 Radiation Output Problem Problem with the device's intended output of radiation. Problem with a medical device's intended output of radiation. A FDA C54451 Medical Device Problem Codes FDA CDRH C133578 4031 Application Program Freezes, Becomes Nonfunctional Problem associated with freezing and becoming nonfunctional of an application program. Problem associated with freezing and becoming nonfunctional of an application program associated with a medical device. A FDA C54451 Medical Device Problem Codes FDA CDRH C133594 4032 Unintended Application Program Shut Down Problem associated with an unintended shut down by malfunction of the application program. Problem associated with an unintended shut down by malfunction of a medical device application program. C FDA C54451 Medical Device Problem Codes FDA CDRH C62973 1069 Break Material Break|Device Breakage Problem associated with undesired damage or breakage of those materials used in the device construction. A fracture of a medical device or one of its components. C FDA C54451 Medical Device Problem Codes FDA CDRH C48660 3189 No Apparent Adverse Event If a value for test has to be provided, but has no given criteria (e.g., the result is for "report only" or "monitoring").|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. C FDA C54451 Medical Device Problem Codes FDA CDRH C63033 1012 Device Alarm System Alarm Failure|Alarm, Failure To Problem associated with the alarm system of the device. Problem associated with the alarm system of a medical device. C FDA C54451 Medical Device Problem Codes FDA CDRH C63250 2588 Defective Device Device, Defective Problem associated with having flaws or dimensional deviations greater than acceptable for the intended use of the device. A medical device that has a defect in structure or function. C FDA C54451 Medical Device Problem Codes FDA CDRH C53269 3190 Insufficient Information No Answer Provided An adverse event appears to have occurred but there is not yet enough information available to classify the device problem. Information regarding the subject is unknown or inaccessible at this time. C FDA C54451 Medical Device Problem Codes FDA CDRH C62965 1546 Material Rupture Rupture Problem associated with perforations that lead to bursting of the device. Problem associated with perforations that lead to bursting of a medical device. C FDA C54451 Medical Device Problem Codes FDA CDRH C63058 1354 Leak / Splash Leak(s) Problem associated with the escape of a liquid or gas from the vessel or container in which it is housed. The unintended escape of a substance contained within a medical device. C FDA C54451 Medical Device Problem Codes FDA CDRH C62814 3026 Unintended Movement Problem associated with an undesired movement of the device, which may be related to the device- malfunction, misdiagnosis, or mistreatment. Movement of a medical device to an unintended location within the body. C FDA C54451 Medical Device Problem Codes FDA CDRH C62994 2440 Failure to Calibrate Calibrate, Failure To Problem associated with the failure of the device to perform a self-calibration procedure or process designed to assure the accuracy and proper performance of the device. Problem associated with the failure of a medical device to perform a self-calibration procedure or process designed to assure the accuracy and proper performance of the device. C FDA C54451 Medical Device Problem Codes FDA CDRH C62970 1153 Degraded Material Degradation Problem associated with a undesired change in the chemical structure, physical properties, or appearance in the materials that are used in the device construction. Problem associated with a undesired change in the chemical structure, physical properties, or appearance in the materials that are used in a medical device construction. C FDA C54451 Medical Device Problem Codes FDA CDRH C63249 1149 Deflation Problem Deflation Difficulties Problem associated with the inability of the device to release its contents. Problem associated with the inability of a medical device to release its contents. C FDA C54451 Medical Device Problem Codes FDA CDRH C63269 1112 Computer Software Problem Computer Software Error Problem associated with written programs, codes, and/or software system that affects device performance or communication with another device. Issue associated with written programs, codes, and/or software system that affects device performance or communication with another device. C FDA C54451 Medical Device Problem Codes FDA CDRH C63036 1004 Accessory Incompatible Accessories, Incompatible An accessory required for the intended purpose of the device appears incompatible with device, thus compromising the intended function of the device. An accessory required for the intended purpose of a medical device appears incompatible with device, thus compromising the intended function of a medical device. C FDA C54451 Medical Device Problem Codes FDA CDRH C62950 2923 Device Dislodged or Dislocated Problems associated with the device not remaining in an expected location. An issue associated with a medical device or a piece of the medical device that has moved from the intended location. C FDA C54451 Medical Device Problem Codes FDA CDRH C62932 3015 Protective Measures Problem Problem associated with any deviations from the documented specifications of the device that relate to the implemented and inherited design features specific to devices used for reducing risks to patient or caregiver or maintaining risks within specified levels. Problem associated with any deviations from the documented specifications of a medical device that relate to the implemented and inherited design features specific to devices used for reducing risks to patient or caregiver or maintaining risks within specified levels. C FDA C54451 Medical Device Problem Codes FDA CDRH C62972 1074 Burst Container or Vessel Material Burst Problem associated with the pressure inside a vessel or container rising to such a degree that the container ruptures. Problem associated with the pressure inside a vessel or container rising to such a degree that the container ruptures. C FDA C54451 Medical Device Problem Codes FDA CDRH C63223 1171 Disconnection Broken Connection|Disconnect Problem associated with the linking of the device having a sufficient open space to prevent gas, liquid or electrical current flow between connectors. Problem associated with the linking of a medical device having a sufficient open space to prevent gas, liquid or electrical current flow between connectors. C FDA C54451 Medical Device Problem Codes FDA CDRH C63132 1260 Fracture Fracture(s) Of Device/Material Problem associated with a partial or full-thickness crack in the device materials. Problem associated with a partial or full-thickness crack in a medical device materials. C FDA C54451 Medical Device Problem Codes FDA CDRH C63015 2284 Device Damaged Prior to Use Damaged Item|Damage, Internal/External|Item Damaged Prior To Use Problem associated with packaging or shipping damage prior to the use of the device. Problem associated with packaging or shipping damage prior to the use of a medical device. C FDA C54451 Medical Device Problem Codes FDA CDRH C62883 1437 Overheating of Device Overheat Problem associated with the device producing high temperatures, such that its operation is compromised or harm is caused (e.g. overheating that produces melting of components or automatic shutdown). Problem associated with a medical device producing high temperatures, such that its operation is compromised or harm is caused (e.g. overheating that produces melting of components or automatic shutdown). C FDA C54451 Medical Device Problem Codes FDA CDRH C62823 2182 Insufficient Flow or Under Infusion Underinfusion|Underdelivery Problem associated with an insufficient dose of therapeutic agents, e.g., drugs or fluids being delivered into a patient under positive pressure. Problem associated with an insufficient dose of therapeutic agents, e.g., drugs or fluids being delivered into a patient under positive pressure. C FDA C54451 Medical Device Problem Codes FDA CDRH C62862 2017 Improper or Incorrect Procedure or Method Improper Or Incorrect Method|Method Improper/Incorrect|Procedure, Improper/Incorrect Problem associated with the use of the device in terms of nonconforming to that device's intended use, specifications, procedure and process or service instructions and information provided by the device manufacturers. Problem associated with the use of a medical device in terms of nonconforming to that device's intended use, specifications, procedure and process or service instructions and information provided by a medical device manufacturers. C FDA C54451 Medical Device Problem Codes FDA CDRH C62964 1562 Material Separation Separates|Separation Problem associated with an undesired disassociation or breaking apart of the device. Problem associated with an undesired disassociation or breaking apart of a medical device. C FDA C54451 Medical Device Problem Codes FDA CDRH C62971 1135 Crack Material Crack|Crack(s) Problem associated with an undesired partial separation and/or a visible opening along the length or width in the materials that are used in the device construction. Problem associated with an undesired partial separation and/or a visible opening along the length or width in the materials that are used in a medical device construction. C FDA C54451 Medical Device Problem Codes FDA CDRH C63214 1194 Electromagnetic Interference Problem associated with a measure of electromagnetic radiation from equipment. Problem associated with a measure of electromagnetic radiation from equipment. C FDA C54451 Medical Device Problem Codes FDA CDRH C63110 2954 Improper Flow or Infusion Problem associated with the regulation and delivery of therapeutic agents (e.g. air, gas, drugs or fluids into a device or a patient under positive pressure). Problem associated with the regulation and delivery of therapeutic agents (e.g. air, gas, drugs or fluids into a device or a patient under positive pressure). C FDA C54451 Medical Device Problem Codes FDA CDRH C63156 1596 Problem with Sterilization Sterilization Failure|Sterilization, Inadequate Device was not sterilized properly during reprocessing. The medical device was not sterilized properly during reprocessing. C FDA C54451 Medical Device Problem Codes FDA CDRH C62895 1426 Material Opacification Opaque|Opacification Problem associated with an undesirable opaqueness or cloudiness. Problem associated with an undesirable opaqueness or cloudiness. C FDA C54451 Medical Device Problem Codes FDA CDRH C62882 1311 Excess Flow or Over-Infusion Overinfusion|Overdelivery Problem associated with a delivery overdose of therapeutic agents, such as drugs or fluids being delivered into a device or a patient. Problem associated with a delivery overdose of therapeutic agents, such as drugs or fluids being delivered into a medical device or a patient. C FDA C54451 Medical Device Problem Codes FDA CDRH C62966 1504 Material Puncture / Hole Puncture Device material(s) punctured leading to undesired holes/openings. Medical device material(s) punctured leading to undesired holes/openings. C FDA C54451 Medical Device Problem Codes FDA CDRH C62949 1669 Failure to Unfold or Unwrap Difficult To Unfold Or Unwrap Problem associated with the comprising materials' deformation in that device fails to open its wrapping or open/extend in a certain manner i.e. balloon or lens. Problem associated with the comprising materials' deformation in that device fails to open its wrapping or open/extend in a certain manner i.e. balloon or lens. C FDA C54451 Medical Device Problem Codes FDA CDRH C62923 2506 Structural Problem Structural Failure Problem associated with the basic physical construction or physical make up of the device. Problem associated with the basic physical construction or physical make up of a medical device. C FDA C54451 Medical Device Problem Codes FDA CDRH C62908 1385 Melted Material Molten|Melts Problem associated with a solid device being transformed into a molten or liquid state. Problem associated with a solid device being transformed into a molten or liquid state. C FDA C54451 Medical Device Problem Codes FDA CDRH C62904 1183 No Display / Image Display, Failure To Problem associated with the absence of display or image. Problem associated with the absence of display or image on a medical device. C FDA C54451 Medical Device Problem Codes FDA CDRH C63143 1245 Fire Problem associated with the combustion of the device with a steady flame. Problem associated with the combustion of a medical device with a steady flame. C FDA C54451 Medical Device Problem Codes FDA CDRH C63254 1146 Decrease in Suction Suction, Decrease In|Incomplete Aspiration|Aspiration, Incomplete Problem associated with the removal of fluid or gas from a body cavity due to decreased suction. Problem associated with the removal of fluid or gas from a body cavity due to decreased suction. C FDA C54451 Medical Device Problem Codes FDA CDRH C63286 1071 Thermal Decomposition of Device Burned|Burnt|Burn Problems associated with a discoloration or destruction as a result of thermal decomposition of the device. Problems associated with a discoloration or destruction as a result of thermal decomposition of a medical device. C FDA C54451 Medical Device Problem Codes FDA CDRH C63196 1539 Failure to Analyze Signal Rhythm, Failure To Diagnose|Failure To Diagnose Rhythm|Rhythm, Failure To Analyze Problem with the device not analyzing a signal. Problem with a medical device not analyzing a signal. C FDA C54451 Medical Device Problem Codes FDA CDRH C63174 2340 Failure to Infuse Infuse, Failure To Failure (=complete nonperformance) with regard to the intended function of infusion. Failure (=complete nonperformance) with regard to the intended function of infusion. C FDA C54451 Medical Device Problem Codes FDA CDRH C63043 2616 Malposition of device Malposition Problem associated with the device being positioned in a location other than intended or specified. Problem associated with a medical device being positioned in a location other than intended or specified. C FDA C54451 Medical Device Problem Codes FDA CDRH C63079 1604 Increase in Suction Excessive Aspiration|Aspiration, Excessive|Suction, Increase In Problem associated with the removal of excess fluid or gas from a body cavity due to increased suction. Problem associated with the removal of excess fluid or gas from a body cavity due to increased suction. C FDA C54451 Medical Device Problem Codes FDA CDRH C63016 2317 Device Contamination with Body Fluid Blood Contaminated Device Problem associated with the undesired presence of body fluid in/on the device, which are not part of the documented device specifications and requirements. Problem associated with the undesired presence of body fluid in/on a medical device, which are not part of the documented device specifications and requirements. C FDA C54451 Medical Device Problem Codes FDA CDRH C63021 2306 Component Missing Components, Missing A device component(s) found to be missing when delivered to the user facility. A device component(s) found to be missing when delivered to the user facility. C FDA C54451 Medical Device Problem Codes FDA CDRH C62948 1506 Product Quality Problem Quality, Unsatisfactory Or Poor|Device Or Device Component Quality Issue Problem associated with an inherent device characteristic that is not satisfactory as specified or delivered. A difficulty with the quality of part of the device or the device itself. C FDA C54451 Medical Device Problem Codes FDA CDRH C62943 1432 Output above Specifications Device output is exceeding the documented specifications of the device. Device output is exceeding the documented specifications of a medical device. C FDA C54451 Medical Device Problem Codes FDA CDRH C62976 2911 Device Markings / Labelling Problem Problem associated with the written, printed or graphic material accompanying or affixed to the device or any of its packaging. This includes verbal instructions relating to identification, technical description, and usage provided by the device manufacturers. Problems can include but are not limited to this material being unclear, missing, worn out, incorrect or inaccurate. Problem associated with the written, printed or graphic material accompanying or affixed to a medical device or any of its packaging. This includes verbal instructions relating to identification, technical description, and usage provided by a medical device manufacturers. Problems can include but are not limited to this material being unclear, missing, worn out, incorrect or inaccurate. C FDA C54451 Medical Device Problem Codes FDA CDRH C62921 2589 Device Tipped Over Device Tipover Problem associated with the inability of the device to stay in an upright position. Problem associated with the inability of a medical device to stay in an upright position. C FDA C54451 Medical Device Problem Codes FDA CDRH C62960 2984 Mechanics Altered Problem associated with a device mechanical functioning of machinery, moving parts or tools of device being changed or modified. Problem associated with a device mechanical functioning of machinery, moving parts or tools of device being changed or modified. C FDA C54451 Medical Device Problem Codes FDA CDRH C62917 1395 Migration or Expulsion of Device Problem with an implanted or invasive device moving within the body, or being completely expelled from the body. Problem with an implanted or invasive medical device moving within the body, or being completely expelled from the body. C FDA C54451 Medical Device Problem Codes FDA CDRH C62915 1399 Misconnection Improper Connection Problem associated with the connection of the device being improper or not in accordance with device specification, requirements or intended uses. Problem associated with the connection of a medical device being improper or not in accordance with device specification, requirements or intended uses. C FDA C54451 Medical Device Problem Codes FDA CDRH C62952 2900 Connection Problem Problem associated with linking of the device and/or the functional units set up to provide means for a transfer of liquid, gas, electricity or data. Problem associated with linking of a medical device and/or the functional units set up to provide means for a transfer of liquid, gas, electricity or data. C FDA C54451 Medical Device Problem Codes FDA CDRH C63263 1131 Corroded Corrode|Corroded Problem associated with the chemical or electrochemical reaction between materials, usually a metal and its environment that produces a deterioration of the metal and its properties. Problem associated with the chemical or electrochemical reaction between materials, usually a metal and its environment that produces a deterioration of the metal and its properties. C FDA C54451 Medical Device Problem Codes FDA CDRH C63297 2303 Microbial Contamination of Device Contamination, Bacterial|Bacterial Contamination Problem associated with undesired microbial contamination of the device. Problem associated with undesired microbial contamination of a medical device. C FDA C54451 Medical Device Problem Codes FDA CDRH C63255 1490 Decrease in Pressure Pressure, Decrease In Unintended decrease in pressure, compromising the device's intended function. Unintended decrease in pressure, compromising a medical device's intended function. C FDA C54451 Medical Device Problem Codes FDA CDRH C63289 1065 Partial Blockage Blockage Problem related to an obstruction or blockage within the device component (e.g. tube, opening, pipe) that results in a reduction of the flow rate. Problem related to an obstruction or blockage within a medical device component (e.g. tube, opening, pipe) that results in a reduction of the flow rate. C FDA C54451 Medical Device Problem Codes FDA CDRH C63244 1157 Difficult or Delayed Positioning Deploy, Difficult To Problem associated with users experiencing difficulty or delay to position the device to a specified location. Problem associated with users experiencing difficulty or delay to position a medical device to a specified location. C FDA C54451 Medical Device Problem Codes FDA CDRH C63285 1077 Calcified Calcified Material|Calcification Problem associated with buildup of calcium salts on the device. Problem associated with buildup of calcium salts on a medical device. C FDA C54451 Medical Device Problem Codes FDA CDRH C63257 2903 Loss of Data Data Corruption|Data Loss Event in which data is unintentionally permanently or temporarily lost, deleted, corrupted, or overwritten. Event in which data is unintentionally permanently or temporarily lost, deleted, corrupted, or overwritten. C FDA C54451 Medical Device Problem Codes FDA CDRH C63224 1170 Material Discolored Discolored Problem associated with an undesired streak, pattern and/or a noticeable change in color from the rest of the materials used in the device construction. Problem associated with an undesired streak, pattern and/or a noticeable change in color from the rest of the materials used in a medical device construction. C FDA C54451 Medical Device Problem Codes FDA CDRH C63253 2534 Decreased Sensitivity Sensitivity, Decreased|Undersensing Problem with the device being less sensitive to an input than intended or expected. Problem with a medical device being less sensitive to an input than intended or expected. C FDA C54451 Medical Device Problem Codes FDA CDRH C63099 1091 Device Reprocessing Problem Cleaning, Inadequate|Clean, Failure To Problem associated with a failure during any step of reprocessing process (cleaning, disinfection, packaging, labeling, sterilization) of a used or opened from its original packaging, but unused, device. Problem associated with a failure during any step of reprocessing process (cleaning, disinfection, packaging, labeling, sterilization) of a used or opened from its original packaging, but unused, device. C FDA C54451 Medical Device Problem Codes FDA CDRH C63003 1585 Smoking Smoke Problem associated with a cloud of vapor or gas generated from the device, generally associated after a fire or a burn. Problem associated with a cloud of vapor or gas generated from a medical device, generally associated after a fire or a burn. C FDA C54451 Medical Device Problem Codes FDA CDRH C63183 1158 Positioning Failure Deploy, Failure To Problem associated with the inability of the device to be positioned in a specified location. Problem associated with the inability of a medical device to be positioned in a specified location. C FDA C54451 Medical Device Problem Codes FDA CDRH C63123 2459 High Readings Readings, High Reading provided by the device is too high or higher than expected. Reading provided by a medical device is too high or higher than expected. C FDA C54451 Medical Device Problem Codes FDA CDRH C63160 1559 Failure to Sense Sensing, None Problem associated with the failure of the device designed to respond to a physical stimulus (as temperature, illumination, motion) to transmit a resulting signal for interpretation or measurement. Problem associated with the failure of a medical device designed to respond to a physical stimulus (as temperature, illumination, motion) to transmit a resulting signal for interpretation or measurement. C FDA C54451 Medical Device Problem Codes FDA CDRH C63022 1108 Component Incompatible Component(s), Incompatible A component required for the proper functioning of the device is not compatible with other components or subassemblies of the device, thus compromising the intended function of the device. A component required for the proper functioning of a medical device is not compatible with other components or subassemblies of a medical device, thus compromising the intended function of a medical device. C FDA C54451 Medical Device Problem Codes FDA CDRH C63023 2292 Defective Component Components, Defective Problem associated with a device component having flaws of dimensional deviations greater than acceptable for the intended use. Problem associated with a device component having flaws of dimensional deviations greater than acceptable for the intended use. C FDA C54451 Medical Device Problem Codes FDA CDRH C63014 1421 Delivered as Unsterile Product Nonsterility Problem associated with a device being received in such a manner to indicate that its sterility has been compromised (e.g. sterile packaging breached, visible contaminate present). Problem associated with a device being received in such a manner to indicate that its sterility has been compromised (e.g. sterile packaging breached, visible contaminate present). C FDA C54451 Medical Device Problem Codes FDA CDRH C63012 2921 Difficult to Open or Close Problem associated with the use of the device in terms of user experiencing difficulty opening and closing the device, even if the operation is being performed according to labeled instructions for use. Problem associated with the use of a medical device in terms of user experiencing difficulty opening and closing a medical device, even if the operation is being performed according to labeled instructions for use. C FDA C54451 Medical Device Problem Codes FDA CDRH C63179 1175 Failure to Disinfect Disinfection, Inadequate/Improper|Disinfect, Failure To Failure to properly disinfect the device when reprocessing it. Failure to properly disinfect a medical device during reprocessing. C FDA C54451 Medical Device Problem Codes FDA CDRH C63070 1287 Insufficient Heating Heating, Inadequate Problem associated with the device or its components producing temperatures that are not as high as what is specified. Problem associated with a medical device or its components producing temperatures that are not as high as what is specified. C FDA C54451 Medical Device Problem Codes FDA CDRH C63035 2577 Difficult or Delayed Activation Activation, Difficult Or Delayed|Activation, Difficult /Delayed Problem associated with delayed or difficult activation of the device. Problem associated with delayed or difficult activation of a medical device. C FDA C54451 Medical Device Problem Codes FDA CDRH C63046 2460 Low Readings Readings, Low Reading provided by the device is too low or lower than expected. Reading provided by a medical device is too low or lower than expected. C FDA C54451 Medical Device Problem Codes FDA CDRH C63158 1573 Defibrillation Problem Shock, Failure To Deliver Problem associated with the inability of the device to provide an appropriate or successful electrical shock. Problem associated with the inability of a medical device to provide an appropriate or successful electrical shock. C FDA C54451 Medical Device Problem Codes FDA CDRH C63042 2882 Application Security Problem Computer Virus Infection Problem associated with the acquisition of computer programming codes that can replicate and spread from one computer system to another thereby leading to damaged software, hardware and data. Problem associated with the acquisition of computer programming codes that can replicate and spread from one computer system to another thereby leading to damaged software, hardware and data. C FDA C54451 Medical Device Problem Codes FDA CDRH C63055 1371 Loose or Intermittent Connection Connection(s), Loose Problem associated with the connection of the device being loose or intermittent. Problem associated with the connection of a medical device being loose or intermittent. C FDA C54451 Medical Device Problem Codes FDA CDRH C63034 3009 Positioning Problem Problem associated with the movement of the device to an intended location. Problem associated with the movement of a medical device to an intended location. C FDA C54451 Medical Device Problem Codes FDA CDRH C63007 1198 Electrical /Electronic Property Problem Device Electrical Issue|Electrical Failure Problem associated with a failure of the electrical circuitry of the device. Problem associated with a failure of the electrical circuitry of a medical device. C FDA C54451 Medical Device Problem Codes FDA CDRH C63078 2535 Increased Sensitivity Oversensing|Sensitivity, Increased Problem with the device being more sensitive to an input than intended or expected. Problem with a medical device being more sensitive to an input than intended or expected. C FDA C54451 Medical Device Problem Codes FDA CDRH C63185 1133 Failure to Deliver Shock Countershock, Failure To Deliver|Failure To Countershock Problem associated with the failure of the device to deliver electrical energy intended to change an electrical rhythm. Problem associated with the failure of a medical device to deliver electrical energy intended to change an electrical rhythm. C FDA C54451 Medical Device Problem Codes FDA CDRH C63071 1130 Insufficient Cooling Cooling, Inadequate Problem associated with the device insufficiently cooled in device active (working) or/and non-active (nonworking) state. Problem associated with a medical device insufficiently cooled in device active (working) or/and non-active (nonworking) state. C FDA C54451 Medical Device Problem Codes FDA CDRH C63141 1246 Flaked Flaked Material|Flaking Problem associated with the detachment of small pieces of the coating film of a material. Problem associated with the detachment of small pieces of the coating film of a material. C FDA C54451 Medical Device Problem Codes FDA CDRH C62876 1457 Perivalvular Leak Paravalvular Leak(s)|Leak(s), Perivalvular Problem associated with the escape of blood around a heart valve, particularly around its leaflets. Problem associated with the escape of blood around a heart valve, particularly around its leaflets. C FDA C54451 Medical Device Problem Codes FDA CDRH C62818 1162 Unintended power up Device Energization, Unintended|Unintended Device Energization Problem associated with the device turning on when not intended. Problem associated with a medical device turning on when not intended. C FDA C54451 Medical Device Problem Codes FDA CDRH C62846 3020 Scratched Material Scratched Problem associated with an undesirable shallow cut or narrow groove in the surface of the device materials. Problem associated with an undesirable shallow cut or narrow groove in the surface of a medical device materials. C FDA C54451 Medical Device Problem Codes FDA CDRH C62847 1544 Material Too Rigid or Stiff Rigid|Rigid Or Stiff Problem associated with an undesired material change in physical property, characterized by rigidity (it resists deformation in response to an applied force). Problem associated with an undesired material change in physical property, characterized by rigidity (it resists deformation in response to an applied force). C FDA C54451 Medical Device Problem Codes FDA CDRH C67508 2582 Date/Time-Related Software Problem Problem associated with programming of calendar dates and/or time as a factor in the operation of the device. Problem associated with programming of calendar dates and/or time as a factor in the operation of a medical device. C FDA C54451 Medical Device Problem Codes FDA CDRH C64335 2973 Battery Problem: Low Impedance Problem related to decreased battery internal impedance. Problem related to decreased battery internal impedance. C FDA C54451 Medical Device Problem Codes FDA CDRH C64336 2947 Battery Problem: High Impedance Problem related to increased battery internal impedance. Problem related to increased battery internal impedance. C FDA C54451 Medical Device Problem Codes FDA CDRH C64343 3191 Appropriate Term/Code Not Available The device problem is not adequately described by any other term. Note: this code must not be used unless there is no other feasible code. The preferred term should be documented when submitting an adverse event report. This information will be used to determine if a new term should be added to the code table. A medical device problem is not adequately described by any other term. Note: this code must not be used unless there is no other feasible code. C FDA C54451 Medical Device Problem Codes FDA CDRH C64348 2899 Computer System Security Problem Problem associated with unauthorized access to or modification of a software system resulting in a loss of confidentiality, integrity, or availability of written program code, application software, or data or entire device. Problem associated with unauthorized access to or modification of a software system resulting in a loss of confidentiality, integrity, or availability of written program code, application software, or data or entire medical device. C FDA C54451 Medical Device Problem Codes FDA CDRH C64339 1496 Device Difficult to Program or Calibrate Program, Difficult To The device is difficult to program, calibrate or set to desired state, even by appropriately trained user/operator. A medical device that is difficult to program, calibrate or set to desired state, even by appropriately trained user/operator. C FDA C54451 Medical Device Problem Codes FDA CDRH C62981 2426 High pH pH, High pH higher than expected and / or anticipated. pH higher than expected and/or anticipated. C FDA C54451 Medical Device Problem Codes FDA CDRH C62940 2312 Incomplete or Missing Packaging Packaging, Incomplete/Missing Problem associated with the nonconformance to the device specifications due to incomplete or missing packaging that may compromise the device operation as intended. Problem associated with the nonconformance to a medical device specifications due to incomplete or missing packaging that may compromise a medical device operation as intended. C FDA C54451 Medical Device Problem Codes FDA CDRH C62962 2981 Material Twisted / Bent Problem associated with deformations that lead to twisting or bending of the device. Medical device problem associated with deformations that lead to twisting or bending of the device. C FDA C54451 Medical Device Problem Codes FDA CDRH C62990 1466 Failure to Run on Battery Portable Mode, Failure To Run On Problem associated with the device failing to operate when not connected to a fixed power source. Problem associated with a medical device failing to operate when not connected to a fixed power source. C FDA C54451 Medical Device Problem Codes FDA CDRH C62958 1398 Misassembled Misassembly Problem associated with incorrect assembly of the device or constituents after being put into use. Problem associated with incorrect assembly of the device or constituents after being put into use. C FDA C54451 Medical Device Problem Codes FDA CDRH C62993 1081 Failure to Capture Capture, Failure To Problem associated with the failure to achieve effective and consistent depolarization of the heart resulting from the electrical stimulus of the pacemaker. Failure of a medical device to cause myocardial depolarization. C FDA C54451 Medical Device Problem Codes FDA CDRH C62906 2988 Naturally Worn Problem associated with material damage to a surface, usually involving progressive loss or displacement of material, due to relative motion between that surface and a contacting substance or substances. Problem associated with material damage to a surface, usually involving progressive loss or displacement of material, due to relative motion between that surface and a contacting substance or substances. C FDA C54451 Medical Device Problem Codes FDA CDRH C62983 2960 Compatibility Problem Compatibility Problem associated with compatibility between device, patients or substances (medication, body fluid, etc.) Problem associated with compatibility between device, patients or substances (medication, body fluid, etc.). C FDA C54451 Medical Device Problem Codes FDA CDRH C62929 1536 Retraction Problem Retract, Failure To Problem associated with drawing back the device to an intended location. Problem associated with drawing back a medical device to an intended location. C FDA C54451 Medical Device Problem Codes FDA CDRH C62916 1473 Application Program Problem: Power Calculation Error Power, Miscalculation Of Problem associated with the written program code or application software used by the device for calculations related to device power. Problem associated with the written program code or application software used by a medical device for calculations related to device power. C FDA C54451 Medical Device Problem Codes FDA CDRH C62961 1384 Mechanical Problem Mechanical Failure Problems associated with mechanical actions or defects, including moving parts or subassemblies, etc. Problems associated with mechanical actions or defects of a medical device, which includes any moving parts or subassemblies, etc. C FDA C54451 Medical Device Problem Codes FDA CDRH C62900 1435 No Device Output Output, None Problem associated with no measurement outcome, value or data obtained from the device. Problem associated with no measurement outcome, value or data obtained from a medical device. C FDA C54451 Medical Device Problem Codes FDA CDRH C62947 1583 Inadequacy of Device Shape and/or Size Size, Incorrect The physical size and/or shape of the device was inadequate with regard to the patient's anatomy. The physical size and/or shape of a medical device was inadequate with regard to the patient's anatomy. C FDA C54451 Medical Device Problem Codes FDA CDRH C62985 2308 Inadequate Filtration Process Filtration Process, Inadequate Problem associated with the filter failing to remove items or substances which should have been removed. Problem associated with the filter failing to remove items or substances which should have been removed. C FDA C54451 Medical Device Problem Codes FDA CDRH C62967 2205 Material Perforation Perforation Material constituting device is perforated possibly compromising the device's intended purpose. Material constituting medical device is perforated possibly compromising the device's intended purpose. C FDA C54451 Medical Device Problem Codes FDA CDRH C62951 2915 Device Damaged by Another Device Problem associated with one device causing harm to another device. Problem associated with one device causing harm to another device. C FDA C54451 Medical Device Problem Codes FDA CDRH C62987 1683 Failure to Zero Zero, Failure To Problem associated with the device failing to set a variable, register, or other storage location back to zero. Problem associated with a medical device failing to set a variable, register, or other storage location back to zero. C FDA C54451 Medical Device Problem Codes FDA CDRH C62992 1476 Failure to Power Up Power-Up, Failure To Problem associated with the inability of the device to turn on related to energy delivered to the device. Problem associated with the inability of a medical device to turn on related to energy delivered to a medical device. C FDA C54451 Medical Device Problem Codes FDA CDRH C62982 2910 Device Ingredient or Reagent Problem Problem associated with any deviations from the documented specifications of the device that relate to any ingredient or reagent characterization. Problem associated with any deviations from the documented specifications of a medical device that relate to any ingredient or reagent characterization. C FDA C54451 Medical Device Problem Codes FDA CDRH C62919 2682 Patient-Device Incompatibility Problem associated with the interaction between the patient's physiology or anatomy and the device that affects the patient and/or the device. Problem associated with the interaction between the patient's physiology or anatomy and a medical device that affects the patient and/or the device. C FDA C54451 Medical Device Problem Codes FDA CDRH C62942 3004 Output below Specifications Device output is below the documented specifications of the device. Device output is below the documented specifications of a medical device. C FDA C54451 Medical Device Problem Codes FDA CDRH C62969 1261 Material Fragmentation Fragmentation Problem associated with small pieces of the device breaking off unexpectedly. Problem associated with small pieces of a medical device breaking off unexpectedly. C FDA C54451 Medical Device Problem Codes FDA CDRH C62991 1532 Failure to Reset Reset, Failure To Problem associated with the device failing to set a variable, register, or other storage location back to a prescribed state. Problem associated with a medical device failing to set a variable, register, or other storage location back to a prescribed state. C FDA C54451 Medical Device Problem Codes FDA CDRH C63233 1316 Difficult to Insert Insertion Difficulties Problem associated with problems introducing or inserting the device, even if the user is operating the device in accordance with the instructions for use or labeling. Problem associated with problems introducing or inserting a medical device, even if the user is operating the device in accordance with the instructions for use or labeling. C FDA C54451 Medical Device Problem Codes FDA CDRH C63275 1095 Clumping in Device or Device Ingredient Clumping Problem associated with the aggregation of particles into irregular masses. Problem associated with the aggregation of particles into irregular masses. C FDA C54451 Medical Device Problem Codes FDA CDRH C63281 2288 Aborted Charge Charge, Aborted Problem associated with the premature ending of the charging process (e.g. of a battery or other charge storage device). Problem associated with the premature ending of the charging process (e.g. of a battery or other charge storage device). C FDA C54451 Medical Device Problem Codes FDA CDRH C63232 1331 Difficult to Interrogate Interrogate, Difficult To Problem associated with difficulty of a transponder system to trigger a response. Problem associated with difficulty of a transponder system to trigger a response. C FDA C54451 Medical Device Problem Codes FDA CDRH C63280 2586 Delayed Charge Time Charge Times, Delayed Problem associated with an unexpected amount of time required to charge the device (e.g. a delay in starting charging or a longer than expected charge time). Problem associated with an unexpected amount of time required to charge a medical device (e.g. a delay in starting charging or a longer than expected charge time). C FDA C54451 Medical Device Problem Codes FDA CDRH C63195 1047 Failure to Back-Up Back-Up, Failure To Problem associated with the inability to backup or to retrieve a backed up version (corrupted file) of device data or system files. Problem associated with the inability to backup or to retrieve a backed up version (corrupted file) of medical device data or system files. C FDA C54451 Medical Device Problem Codes FDA CDRH C63242 2907 Detachment of Device or device Component Device Or Device Component Detached Problem associated with the separation of the device from its physical construct, integrity, or chassis. Problem associated with the separation of a medical device from its physical construct, integrity, or chassis. C FDA C54451 Medical Device Problem Codes FDA CDRH C63264 1126 Use of Incorrect Control Settings Control Settings Incorrect Problem associated with the use of the device in terms of inappropriate and false control setting for the device's specified operation and/or intended use. Problem associated with the use of a medical device in terms of inappropriate and false control setting for a medical device's specified operation and/or intended use. C FDA C54451 Medical Device Problem Codes FDA CDRH C63266 2901 Contamination of Device Ingredient or Reagent Problem associated with the undesired introduction of impurities either chemical or microbiological in nature, or of foreign matter into or onto the device ingredient or reagent. Problem associated with the undesired introduction of impurities either chemical or microbiological in nature, or of foreign matter into or onto a medical device ingredient or reagent. C FDA C54451 Medical Device Problem Codes FDA CDRH C63251 1014 Defective Alarm Alarm, Defective The device alarm does not operate as expected and/or in agreement with device's specifications. A medical device alarm does not operate as expected and/or in agreement with device's specifications. C FDA C54451 Medical Device Problem Codes FDA CDRH C63210 1212 Entrapment of Device Entrapment Problem associated with the device caught within patient vasculature, tissue, or other device. Issue associated with a medical device and/or device accessories caught within patient vasculature, tissue, or other devices or device components. C FDA C54451 Medical Device Problem Codes FDA CDRH C63310 1019 No Audible Alarm Alarm, Not Audible The device fails to emit an audible alarm. A medical device fails to emit an audible alarm. C FDA C54451 Medical Device Problem Codes FDA CDRH C63318 1670 Use of Device Problem Device, Incorrect Care/Use Of Problem associated with failure to process, service, or operate the device according to the manufacturer's recommendations or recognized best practices. Problem associated with failure to process, service, or operate a medical device according to the manufacturer's recommendations or recognized best practices. C FDA C54451 Medical Device Problem Codes FDA CDRH C63272 1099 Collapse Problem associated with the buckling or crushing of material from external forces. Problem associated with the buckling or crushing of material from external forces. C FDA C54451 Medical Device Problem Codes FDA CDRH C63190 1540 Failure to Convert Rhythm Rhythm, Failure To Convert Failure of the device therapy or set of therapies to terminate the harmful cardiac rhythm that the therapy is meant to terminate. Failure of a medical device therapy or set of therapies to terminate the harmful cardiac rhythm that the therapy is meant to terminate. C FDA C54451 Medical Device Problem Codes FDA CDRH C63131 1262 Material Frayed Frayed Problem associated with the comprising materials having damaged edges. Problem associated with the comprising materials having damaged edges. C FDA C54451 Medical Device Problem Codes FDA CDRH C63191 1114 Failure to Conduct Conduct, Failure To Problem associated with the inability of the device to allow a current of electricity to pass or to conduct electricity continuously along an electrical path. Problem associated with the inability of a medical device to allow a current of electricity to pass or to conduct electricity continuously along an electrical path. C FDA C54451 Medical Device Problem Codes FDA CDRH C63133 2944 Device Contamination with Chemical or Other Material Foreign Material Problem associated with contamination of the device with chemical substance or other non biologic material. Problem associated with contamination of a medical device with a chemical substance or other non biologic material. C FDA C54451 Medical Device Problem Codes FDA CDRH C63222 1177 Material Disintegration Disintegrate Problem associated with material breaking into small particles. Problem associated with material of a medical device breaking into small pieces. C FDA C54451 Medical Device Problem Codes FDA CDRH C63320 1480 Premature End-of-Life Indicator Premature EOL Problem with the early or unexpected activation of the end-of-life indicator. Problem with the early or unexpected activation of the end-of-life indicator. C FDA C54451 Medical Device Problem Codes FDA CDRH C63220 1189 Application Program Problem: Dose Calculation Error Dose Calculation Error Problem associated with the written program code or application software used by the device to calculate specific measurements or quantities managed by the device. Problem associated with the written program code or application software used by a medical device to calculate specific measurements or quantities managed by the device. C FDA C54451 Medical Device Problem Codes FDA CDRH C63207 1182 Erratic or Intermittent Display Display, Erratic A device does not consistently display the same message, result, reading, or image. e.g. the display might flicker, switch between readings or messages, or go completely blank for brief periods of time. A medical device that does not consistently display the same message, result, reading, or image. e.g. the display might flicker, switch between readings or messages, or go completely blank for brief periods of time. C FDA C54451 Medical Device Problem Codes FDA CDRH C63315 1483 Premature Elective Replacement Indicator Premature ERI Problems with the early or unexpected activation of the elective replacement indicator. Problems with the early or unexpected activation of the elective replacement indicator. C FDA C54451 Medical Device Problem Codes FDA CDRH C63129 2529 Fumes or Vapors Fumes/Vapors Problem associated with the visibility, odor, or toxicity of an ambient vapor or gas. Problem associated with the visibility, odor, or toxicity of an ambient vapor or gas. C FDA C54451 Medical Device Problem Codes FDA CDRH C63293 1062 Biofilm coating in Device Biofilm Coating Problem associated with the undesired introduction of a biofilm coating into or onto the device. Problem associated with the undesired introduction of a biofilm coating into or onto a medical device. C FDA C54451 Medical Device Problem Codes FDA CDRH C63245 2526 Dent in Material Dent Problem associated with a undesired change in shape, characterized by the presence of a slight hollow (dent) in the device surface. Problem associated with a undesired change in shape, characterized by the presence of a slight hollow (dent) in a medical device surface. C FDA C54451 Medical Device Problem Codes FDA CDRH C63228 1528 Difficult to Remove Removal Difficulties Problem associated with the use of the device in terms of user experiencing difficulty to take out or get rid of the device, even if the user is operating device in accordance with the instructions for use or labeling. Problem associated with the use of a medical device in terms of user experiencing difficulty to take out or get rid of the device, even if the user is operating device in accordance with the instructions for use or labeling. C FDA C54451 Medical Device Problem Codes FDA CDRH C63248 2976 Material Deformation Problem associated with an undesired material change in shape or property caused by external forces. Problem associated with an undesired material change in shape or property caused by external forces. C FDA C54451 Medical Device Problem Codes FDA CDRH C63234 1254 Difficult to Fold or Unfold Fold, Difficult To Problem associated with the use of the device in terms of user experiencing difficulty to close or to spread out/extend length of the device, even if the operation is being performed according to labeled instructions for use. Problem associated with the use of a medical device in terms of the user experiencing difficulty to close or to spread out/extend length of the device, even if the operation is being performed according to labeled instructions for use. C FDA C54451 Medical Device Problem Codes FDA CDRH C63247 1011 Delayed Alarm Alarm, Delayed The device alarm system operates with delay. A medical device alarm system operates with delay. C FDA C54451 Medical Device Problem Codes FDA CDRH C63274 1096 Coagulation in Device or device Ingredient Coagulation Problem associated with the undesired characterization of congealing, solidifying, thickening, curdling. Problem associated with the undesired characterization of congealing, solidifying, thickening, curdling. C FDA C54451 Medical Device Problem Codes FDA CDRH C63236 2919 Device-Device Incompatibility Problem associated with the incompatibility of two or more devices while being operated in the same use environment thereby leading to a dysfunction of more than one device. The inability of two or more devices to work together. C FDA C54451 Medical Device Problem Codes FDA CDRH C63288 2888 Blocked Connection Problem associated with linking of the device whereby their functional units set up to provide means for a transfer of fluid, gas, or data is prevented or impeded. Problem associated with linking of a medical device whereby their functional units set up to provide means for a transfer of fluid, gas, or data is prevented or impeded. C FDA C54451 Medical Device Problem Codes FDA CDRH C63219 2407 Dull, Blunt Problem associated with a device not being as sharp as intended or expected. Problem associated with a medical device not being as sharp as intended or expected. C FDA C54451 Medical Device Problem Codes FDA CDRH C63241 1517 Failure to Recalibrate Recalibrate, Failure To Problem associated with the failure of the device which is unable to regain a standard level of accuracy when performing a calibration procedure or process designed to assure the accuracy and proper performance of the device. Problem associated with the failure of a medical device which is unable to regain a standard level of accuracy when performing a calibration procedure or process designed to assure the accuracy and proper performance of the device. C FDA C54451 Medical Device Problem Codes FDA CDRH C63259 3025 Unauthorized Access to Computer System Problem associated with an access that was not permitted to the computer system that may lead to modification of program, corruption of data, or and break in network security. This concept is closely associated with computer integrity which is the degree to which a system or component prevents unauthorized access to, or modification of, computer programs or data. Problem associated with an access that was not permitted to the computer system that may lead to modification of program, corruption of data, or and break in network security. This concept is closely associated with computer integrity which is the degree to which a system or component prevents unauthorized access to, or modification of, computer programs or data. C FDA C54451 Medical Device Problem Codes FDA CDRH C63252 1500 Decreased Pump Speed Pump Speed, Decreased Unintended decrease in pump speed and hence, probably, flow rate, compromising the intended function of the device. Unintended decrease in pump speed and subsequent flow rate, compromising the intended function of a medical device. C FDA C54451 Medical Device Problem Codes FDA CDRH C63197 2522 Failure to Align Align, Failure To Problem associated with a circuit, equipment, or system whereby its functions fail to be properly synchronized or its relative positions properly oriented. Problem associated with a circuit, equipment, or system whereby its functions fail to be properly synchronized or its relative positions properly oriented. C FDA C54451 Medical Device Problem Codes FDA CDRH C63198 2524 Failure to Advance Advance, Failure To Problem associated with failure to move the device to an intended location. Problem associated with failure to move a medical device to an intended location. C FDA C54451 Medical Device Problem Codes FDA CDRH C63261 1137 Cross Reactivity Problem associated with the degree to which an antibody or antigen participates in cross reactions. Problem associated with the degree to which an antibody or antigen participates in cross reactions. C FDA C54451 Medical Device Problem Codes FDA CDRH C63317 1251 Difficult to Flush Flush, Difficult To The device is difficult to flush, possibly indicating an obstruction within device. A medical device that is difficult to flush, possibly indicating an obstruction within device. C FDA C54451 Medical Device Problem Codes FDA CDRH C63194 1068 Loss of or Failure to Bond Bond, Failure To Problem associated with lack or loss of adherence between materials intended to be joined together by an adhesive. Problem associated with lack or loss of adherence between materials intended to be joined together by an adhesive. C FDA C54451 Medical Device Problem Codes FDA CDRH C63137 1250 Fluid Leak Fluid Leak(s) Escape (Release, Discharge) of fluid through an unintended location - often accompanied by a loss of pressure and/or output. Escape (release, discharge) of fluid through an unintended location in a medical device that is often accompanied by a loss of pressure and/or output. C FDA C54451 Medical Device Problem Codes FDA CDRH C63208 1214 Material Erosion Erosion Problem associated with a progressive loss of a material from a solid surface. Problem associated with a progressive loss of a material from a solid surface. C FDA C54451 Medical Device Problem Codes FDA CDRH C63287 2889 Deformation Due to Compressive Stress Problem associated with an undesired bulge, bend, bow, kink, or wavy condition observed in the device material resulting from compressive stresses. Problem associated with an undesired bulge, bend, bow, kink, or wavy condition observed in a medical device material resulting from compressive stresses. C FDA C54451 Medical Device Problem Codes FDA CDRH C63316 1267 Gel Leak Gel Leakage Escape (Release, Discharge) of gel through an unintended location - as in leakage of ultrasound gel. Escape or release of gel from containment structures - as in gel filled implant leak. Escape (release, discharge) of gel through an unintended location - as in leakage of ultrasound gel. Escape or release of gel from containment structures - as in gel filled implant leak. C FDA C54451 Medical Device Problem Codes FDA CDRH C63193 1085 Failure to Charge Charge, Failure To Problem associated with inability to initiate the appropriate charging process (e.g. of a battery or other charge storage device). Problem associated with inability to initiate the appropriate charging process (e.g. of a battery or other charge storage device). C FDA C54451 Medical Device Problem Codes FDA CDRH C63212 1205 Emergency Power Failure Problem associated with the failure of the facility's emergency power backup system(s) including generators and/or interruptible power systems (UPS). Problem associated with the failure of the facility's emergency power backup system(s) including generators and/or interruptible power systems (UPS). C FDA C54451 Medical Device Problem Codes FDA CDRH C63105 1337 Inability to Irrigate Irrigate, Inability To Failure (=complete nonperformance) with regard to the intended function of irrigation. Failure (=complete nonperformance) with regard to the intended function of irrigation. C FDA C54451 Medical Device Problem Codes FDA CDRH C63044 2575 Low Sensing Threshold Sensing Threshold, Low Problem associated with the amount of an input required by the device to detect a signal being lower than expected/desired. Problem associated with the amount of an input required by a medical device to detect a signal being lower than expected/desired. C FDA C54451 Medical Device Problem Codes FDA CDRH C63171 1863 Failure to Osseointegrate Osseointegrate, Failure To Problem associated with the failure to see direct anchorage of an implant by the formation of bony tissue around the implant without the growth of fibrous tissue at the bone-implant interface. Problem associated with the failure to see direct anchorage of an implant by the formation of bony tissue around the implant without the growth of fibrous tissue at the bone-implant interface. C FDA C54451 Medical Device Problem Codes FDA CDRH C63104 2339 Inaccurate Delivery Delivery, Inaccurate Delivery at endpoint not as intended; either too low or too high. Delivery at endpoint not as intended; either too low or too high. C FDA C54451 Medical Device Problem Codes FDA CDRH C63142 2183 Fitting Problem Fitting Problems Problem associated with the connection of the device whereby channels, switching systems, and other functional units set up to provide means for a transfer of liquid, gas, electricity, or information do not match or fit. Problem associated with the connection of a medical device whereby channels, switching systems, and other functional units set up to provide means for a transfer of liquid, gas, electricity, or information do not match or fit. C FDA C54451 Medical Device Problem Codes FDA CDRH C63093 1574 Inappropriate Shock Shock, Inappropriate Problem associated with the inappropriate delivery of an electrical energy. Problem associated with the inappropriate delivery of an electrical energy. C FDA C54451 Medical Device Problem Codes FDA CDRH C63045 2458 Low Test Results Test Results, Low Test results provided by the device are too low or lower than expected. Test results provided by a medical device are too low or lower than expected. C FDA C54451 Medical Device Problem Codes FDA CDRH C63063 1336 Material Invagination Invagination Problem associated with an undesired material change in shape, characterized by the infolding of one part within another part of a structure. Problem associated with an undesired material change in shape, characterized by the infolding of one part within another part of a structure. C FDA C54451 Medical Device Problem Codes FDA CDRH C63102 1249 Inaccurate Flow rate Flowrate, Inaccurate Problem associated with fluctuations in the flow volume delivered per time, even if end volume is correct, and delivered in the correct total time. Problem associated with fluctuations in the flow volume delivered per time, even if end volume is correct, and delivered in the correct total time. C FDA C54451 Medical Device Problem Codes FDA CDRH C63087 1319 Inadequate Instructions for Healthcare Professional Instructions, Incorrect Problem associated with inaccuracies in any written, printed, or graphic matter that is affixed to the device or its packaging with any matter that accompanies the device including verbal instructions related to identification, technical description and use of device provided by the device manufacturers that is intended for healthcare professionals. Problem associated with inaccuracies in any written, printed, or graphic matter that is affixed to a medical device or its packaging with any matter that accompanies the device including verbal instructions related to identification, technical description and use of the device provided by the device manufacturers that is intended for healthcare professionals. C FDA C54451 Medical Device Problem Codes FDA CDRH C63157 2536 Inappropriate waveform Spike, Failure To Failure of the device to generate a correctly-shaped pacing output, e.g., a waveform that is too wide. Failure of a medical device to generate a correctly-shaped pacing output, e.g., a waveform that is too wide. C FDA C54451 Medical Device Problem Codes FDA CDRH C63053 2408 Loss of Osseointegration Osseointegration, Loss Of Problem associated with weakened integration of the device at the bone-implant interface due to loss of fibrous and/or bony tissue and leading to compromised anchorage of the device. i.e. 'Loosening/Lysis.' " Problem associated with weakened integration of a medical device at the bone-implant interface due to loss of fibrous and/or bony tissue and leading to compromised anchorage of a medical device. i.e. 'Loosening/Lysis.' C FDA C54451 Medical Device Problem Codes FDA CDRH C63169 1439 Pacing Problem Pace, Failure To Problem associated with the inability of the device to generate a therapeutic simulated heart beat via electrical impulses. Problem associated with the inability of a medical device to generate a therapeutic simulated heart beat via electrical impulses. C FDA C54451 Medical Device Problem Codes FDA CDRH C63122 2457 High Test Results Test Results, High Test results provided by the device are too high or higher than expected. Test results provided by a medical device are too high or higher than expected. C FDA C54451 Medical Device Problem Codes FDA CDRH C63031 2959 Inappropriate or Unexpected Reset Problem associated with the device setting a variable, register, or other storage location to an inappropriate or unexpected state. Problem associated with a medical device setting a variable, register, or other storage location to an inappropriate or unexpected state. C FDA C54451 Medical Device Problem Codes FDA CDRH C63159 2547 Separation Failure Separate, Failure To Problem associated with the device or one of its components failing to detach or separate as intended. Problem associated with a medical device or one of its components failing to detach or separate as intended. C FDA C54451 Medical Device Problem Codes FDA CDRH C63186 2338 Failure to Deliver Deliver, Failure To Failure (=complete nonperformance) with regard to the intended function of delivery. Failure (=complete nonperformance) with regard to the intended function of delivery. C FDA C54451 Medical Device Problem Codes FDA CDRH C63152 1013 False Alarm Alarm, False Problem associated with the device providing incorrect alarm warning or alert to user. Problem associated with a medical device providing incorrect alarm warning or alert to user. C FDA C54451 Medical Device Problem Codes FDA CDRH C63188 2587 Failure to Cut Cut, Failure To Inability of the device to make an incision, pierce or open as intended. Inability of a medical device to make an incision, pierce or open as intended. C FDA C54451 Medical Device Problem Codes FDA CDRH C63184 1211 Failure to Deliver Energy Energy, Failure To Deliver Problem associated with the failure of the device to deliver any energy. Problem associated with the failure of a medical device to deliver any energy. C FDA C54451 Medical Device Problem Codes FDA CDRH C63181 1169 Failure to Discharge Discharge, Failure To Problem associated with the failure of a battery or other charge storage device to appropriately discharge as intended. Does not apply to defibrillation. Problem associated with the failure of a battery or other charge storage device to appropriately discharge as intended. Does not apply to defibrillation. C FDA C54451 Medical Device Problem Codes FDA CDRH C63175 1255 Failure to Fold Fold, Failure To Problem associated with an undesired material change in physical property, characterized by failure to fold. Problem associated with an undesired material change in the physical property of a medical device which is characterized by failure to fold. C FDA C54451 Medical Device Problem Codes FDA CDRH C63067 2341 Intermittent Infusion Infusion, Intermittent Problem associated with the infusion not being steady, characterized by intermittent stoppages to the flow. Problem associated with the infusion not being steady, characterized by intermittent stoppages to the flow. C FDA C54451 Medical Device Problem Codes FDA CDRH C63163 1213 Problem with Removal of Enzymatic Cleaner Enzymatic Cleaner, Failure To Remove Enzymatic cleaner was not removed properly. Enzymatic cleaner was not removed properly from medical device. C FDA C54451 Medical Device Problem Codes FDA CDRH C63076 1310 Inflation Problem Inflation Difficulties Problem associated with the inability of the device to expand or enlarge with the intended inflation agent (e.g. saline or air). Problem associated with the inability of a medical device to expand or enlarge with the intended inflation agent (e.g. saline or air). C FDA C54451 Medical Device Problem Codes FDA CDRH C63077 1501 Increased Pump Speed Pump Speed, Increased Unintended increase in pump speed and hence, probably, flow rate, compromising the intended function of the device. Unintended increase in pump speed and hence, probably, flow rate, compromising the intended function of a medical device. C FDA C54451 Medical Device Problem Codes FDA CDRH C63052 1475 Loss of Power Power, Loss Of Problem associated with the failure of primary power supplied by the facility. Problem associated with the failure of primary power supplied by the facility. C FDA C54451 Medical Device Problem Codes FDA CDRH C63172 2533 Failure to Obtain Sample Samples, Failure To Obtain The device does not collect or transfer the sample. A medical device that does not collect or transfer the sample as intended. C FDA C54451 Medical Device Problem Codes FDA CDRH C63085 1383 Incorrect Measurement Measurements, Inaccurate Measurement obtained from or provided by the device is obviously incorrect. Measurement obtained from or provided by a medical device is obviously incorrect. C FDA C54451 Medical Device Problem Codes FDA CDRH C63082 1494 Off-Label Use Product, Incorrect Problem associated with the device which has been used for an unapproved indication or for an unapproved intended use. Problem associated with a medical device which has been used for an unapproved indication or for an unapproved intended use. C FDA C54451 Medical Device Problem Codes FDA CDRH C63083 1449 Application Program Problem: Parameter Calculation Error Parameter Calculations, Incorrect Problem associated with the written program code or application software used by the device to calculate parameters other than those related to dose or power. Problem associated with the written program code or application software used by a medical device to calculate parameters other than those related to dose or power. C FDA C54451 Medical Device Problem Codes FDA CDRH C63018 1120 Contamination During Use Contamination Problem associated with the undesired introduction of impurities either chemical or microbiological in nature, or of foreign matter into or onto the device at the user facility. Problem associated with the undesired introduction of impurities either chemical or microbiological in nature, or of foreign matter into or onto a medical device at the user facility. C FDA C54451 Medical Device Problem Codes FDA CDRH C63010 1487 Device Difficult to Setup or Prepare Prep, Difficult To Problem associated with the use of the device in terms of user experiencing difficulty in preparing device for use, even if the operation is being performed according to labeled instructions for use. Problem associated with the use of a medical device in terms of user experiencing difficulty in preparing device for use, even if the operation is being performed according to labeled instructions for use. C FDA C54451 Medical Device Problem Codes FDA CDRH C63149 1225 False Negative Result False-Negative Test Result Problem associated with the device incorrectly reporting that something has not been detected and may mislead the operator into not taking certain actions when action should be taken. Problem associated with a medical device incorrectly reporting that something has not been detected and may mislead the operator into not taking certain actions when action should be taken. C FDA C54451 Medical Device Problem Codes FDA CDRH C63050 1633 Loss of Threshold Threshold, Loss Of Problem associated with the loss of the minimum amount of energy, voltage, or current needed to consistently stimulate the heart muscle. Problem associated with the loss of the minimum amount of energy, voltage, or current needed to consistently stimulate the heart muscle. C FDA C54451 Medical Device Problem Codes FDA CDRH C63155 1521 Failure to Transmit Record Record, Failure To Transmit Problem associated with a failure of the device to transmit a record for interpretation or measurement. Problem associated with a failure of a medical device to transmit a record for interpretation or measurement. C FDA C54451 Medical Device Problem Codes FDA CDRH C63176 1252 Flushing problem Flush, Failure To Flushing process was not executed properly. Medical device flushing process was not executed properly. C FDA C54451 Medical Device Problem Codes FDA CDRH C63049 1016 Low Audible Alarm Alarm, Low Audible The audible device alarm cannot be heard clearly. The audible device alarm cannot be heard clearly. C FDA C54451 Medical Device Problem Codes FDA CDRH C63080 1491 Increase in Pressure Pressure, Increase In Unintended increase in pressure, compromising the device's intended function. Unintended increase in pressure, compromising a medical device's intended function. C FDA C54451 Medical Device Problem Codes FDA CDRH C63128 2316 Fungus in Device Environment Fungus Problem associated with the visibility of molds, mildews, yeasts, and/or mushrooms in the immediate environment in which the device is being used. Problem associated with the visibility of molds, mildews, yeasts, and/or mushrooms in the immediate environment in which a medical device is being used. C FDA C54451 Medical Device Problem Codes FDA CDRH C63147 1227 False Positive Result False-Positive Test Result Problem associated with the device incorrectly reporting that something has been detected and may mislead the operator to take certain actions. Problem associated with a medical device incorrectly reporting that something has been detected and may mislead the operator to take certain actions. C FDA C54451 Medical Device Problem Codes FDA CDRH C63092 2283 Inaudible or Unclear Audible Prompt  / Feedback Prompts, Inaudible Voice Problem associated with audible prompts which cannot be heard clearly. Problem associated with audible prompts which cannot be heard clearly. C FDA C54451 Medical Device Problem Codes FDA CDRH C63177 2610 Failure to Fire Fire, Failure To Problem associated with failure of the device to discharge its load (e.g. surgical stapler failed to partially or completely deploy its staples). Problem associated with failure of a medical device to discharge its load (e.g. surgical stapler failed to partially or completely deploy its staples). C FDA C54451 Medical Device Problem Codes FDA CDRH C63124 1291 High impedance Impedance, High Problem associated with higher than intended electrical impedance levels between device and patient connections. Problem associated with higher than intended electrical impedance levels between device and patient connections. C FDA C54451 Medical Device Problem Codes FDA CDRH C63164 1581 Failure to Read Input Signal Input Signal, Failure To Read Problem associated with a failure of the device to read a signal for interpretation or measurement. Problem associated with a failure of a medical device to read a signal for interpretation or measurement. C FDA C54451 Medical Device Problem Codes FDA CDRH C63019 2969 Device Contaminated during manufacture 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. 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. C FDA C54451 Medical Device Problem Codes FDA CDRH C63109 1266 Gas output problem Gas Output, Improper Problem associated with gas output. Problem associated with gas output. C FDA C54451 Medical Device Problem Codes FDA CDRH C63167 1492 Failure to Prime Prime, Failure To Problem associated with the device failing to begin the priming process (i.e. the process of preparation of device for the delivery of fluids). Problem associated with a medical device failing to begin the priming process (i.e. the process of preparation of device for the delivery of fluids). C FDA C54451 Medical Device Problem Codes FDA CDRH C63094 2280 Inappropriate Audible Prompt / Feedback Prompts, Inappropriate Problem with audible messages which do not guide a device user to the correct action. Problem with audible messages which do not guide a device user to the correct action. C FDA C54451 Medical Device Problem Codes FDA CDRH C63039 2983 Mechanical Jam The motion of the device is prevented or restricted. The motion of a medical device is prevented or restricted. C FDA C54451 Medical Device Problem Codes FDA CDRH C63180 2541 Failure to Disconnect Disconnect, Failure To Problem associated with the linking of the device whereby termination of the transfer of liquid, gas, electricity, or information cannot be accomplished, or linking components do not come apart, or disconnect, when expected. Problem associated with the linking of a medical device whereby termination of the transfer of liquid, gas, electricity, or information cannot be accomplished, or linking components do not come apart, or disconnect, when expected. C FDA C54451 Medical Device Problem Codes FDA CDRH C63121 2574 High Sensing Threshold Sensing Threshold, High Problem associated with the amount of input required by the device to detect a signal being higher than expected/desired. Problem associated with the amount of input required by a medical device to detect a signal being higher than expected/desired. C FDA C54451 Medical Device Problem Codes FDA CDRH C63106 1044 Inability to Auto-Fill Autofill, Unable To Complete failure to fill as part of an automated process. For insufficient filling use "Short Fill". For excessive filling use "Overfill". For inconsistent filling use "Volume Accuracy Problem". Complete failure to fill as part of an automated process. For insufficient filling use Short Fill. For excessive filling use Overfill. For inconsistent filling use Volume Accuracy Problem. C FDA C54451 Medical Device Problem Codes FDA CDRH C63173 1332 Failure to Interrogate Interrogate, Failure To Problem associated with the device failure to appropriately respond to signals from a system designed to interrogate its status. Problem associated with a medical device failure to appropriately respond to signals from a system designed to interrogate its status. C FDA C54451 Medical Device Problem Codes FDA CDRH C63068 1121 Intermittent Continuity Continuity, Intermittent Problem associated with intermittent faults in electrical/electronic interconnections. Problem associated with intermittent faults in electrical/electronic interconnections. C FDA C54451 Medical Device Problem Codes FDA CDRH C63161 1582 Failure to Select Signal Signal, Failure To Select Problem associated with the failure of the device to select the appropriate input signal. Problem associated with the failure of a medical device to select the appropriate input signal. C FDA C54451 Medical Device Problem Codes FDA CDRH C63101 1609 Inaccurate Synchronization Synchronization, Inaccurate Problem associated with an error due to imperfect timing of two operations, e.g. signal transmission time. Problem associated with an error due to imperfect timing of two operations, e.g. signal transmission time. C FDA C54451 Medical Device Problem Codes FDA CDRH C63024 1094 Complete Blockage Clogged Problem related to an obstruction or blockage within the device component (e.g. tube, opening, pipe) that results in no flow. An issue in which a medical device has an obstructed lumen. C FDA C54451 Medical Device Problem Codes FDA CDRH C63088 1184 Display or Visual Feedback Problem Display, Incorrect Problem with any deviation from the documented specifications of the device that relate to visual feedback. e.g. the display of information, images on a screen, or output from the device. Problem with any deviation from the documented specifications of a medical device that relate to visual feedback. e.g. the display of information, images on a screen, or output from a medical device. C FDA C54451 Medical Device Problem Codes FDA CDRH C63189 1048 Failure to Convert to Back-Up Back-Up, Failure To Convert To Problem associated with a failure to transition from a primary system, component, file, procedure to a backup in response to a failure in the primary item. Problem associated with a failure to transition from a primary system, component, file, procedure to a backup in response to a failure in the primary item. C FDA C54451 Medical Device Problem Codes FDA CDRH C63165 1502 Failure to Pump Pump, Failure To Problem associated with the device which fails to start pumping. Problem associated with a medical device which fails to start pumping. C FDA C54451 Medical Device Problem Codes FDA CDRH C63072 1318 Labelling, Instructions for Use or Training Problem Instructions, Inadequate Problem associated with device markings / labelling, instructions for use, training and maintenance documentation or guidelines. Problem associated with device markings/labeling, instructions for use, training and maintenance documentation or guidelines. C FDA C54451 Medical Device Problem Codes FDA CDRH C63069 1080 Intermittent Capture Capture, Intermittent Problem associated with the ineffective and inconsistent depolarization of the heart. Problem associated with the ineffective and inconsistent depolarization of the heart. C FDA C54451 Medical Device Problem Codes FDA CDRH C63187 1142 Failure to Cycle Cycle, Failure To Problem associated with the device failing to complete a series of processes or events. Problem associated with a medical device failing to complete a series of processes or events. C FDA C54451 Medical Device Problem Codes FDA CDRH C63047 2285 Low impedance Impedance, Low Problem associated with lower than intended electrical impedance levels between device and patient connections. Problem associated with lower than intended electrical impedance levels between device and patient connections. C FDA C54451 Medical Device Problem Codes FDA CDRH C63064 2287 Intermittent Shock Shock, Intermittent 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. 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. C FDA C54451 Medical Device Problem Codes FDA CDRH C63086 1543 Incorrect Interpretation of signal Rhythm, Incorrect Interpretation Of Problem with the device inappropriately analyzing a signal. Problem with a medical device inappropriately analyzing a signal. C FDA C54451 Medical Device Problem Codes FDA CDRH C63074 2965 Installation-Related Problem Installation Error Problem associated with unsatisfactory installation, configuration, and/or setup of a specific device. Problem associated with unsatisfactory installation, configuration, and/or setup of a specific medical device. C FDA C54451 Medical Device Problem Codes FDA CDRH C62850 2325 Residue After Decontamination Residue Problem associated with the decontamination process not adequately removing unwanted visible soil, foreign material, or organism deposits. Problem associated with the decontamination process not adequately removing unwanted visible soil, foreign material, or organism deposits. C FDA C54451 Medical Device Problem Codes FDA CDRH C62805 1675 Volume Accuracy Problem Volume Accuracy Inconsistent filling of a device. This describes a problem which is observed to vary between overfilling and under filling, and may be intermittent. Use "Overfill" or "Short Fill" if problem is consistent. Inconsistent filling of a medical device. This describes a problem which is observed to vary between overfilling and under filling, and may be intermittent. Use Overfill or Short Fill if problem is consistent. C FDA C54451 Medical Device Problem Codes FDA CDRH C62864 1057 Premature Discharge of Battery Battery, Premature Discharge Of Battery discharging earlier than expected. Battery discharging earlier than expected. C FDA C54451 Medical Device Problem Codes FDA CDRH C62844 1557 Self-Activation or Keying Self-Activation/Keying Problem associated with the unintended activation of the device, or the device having been unexpectedly turned on during use. Problem associated with the unintended activation of a medical device, or a medical device having been unexpectedly turned on during use. C FDA C54451 Medical Device Problem Codes FDA CDRH C62817 1234 Unintended Ejection Film Cartridge Ejection, Unintended Problem associated with unexpected discharge of the device from expected location includes but not limited to the device such as clip appliers, film cartridge, staples. Problem associated with unexpected discharge of a medical device from expected location includes but not limited to a medical device such as clip appliers, film cartridge, staples. C FDA C54451 Medical Device Problem Codes FDA CDRH C62854 1522 Reflux within Device Reflux Problem associated with partial backflow, compromising the device's flow output. Problem associated with partial backflow, compromising a medical device's flow output. C FDA C54451 Medical Device Problem Codes FDA CDRH C62833 2170 Suction Problem Suction Failure Problem associated with suction equipment, which may be a manual, electrical, vacuum or pressure source operated to evacuate and remove undesired substances (air, gas, fluid, or particulates) via tubing and collection bag. Problem associated with suction equipment, which may be a manual, electrical, vacuum or pressure source operated to evacuate and remove undesired substances (air, gas, fluid, or particulates) via tubing and collection bag. C FDA C54451 Medical Device Problem Codes FDA CDRH C62837 2595 Sparking Problem associated with a flash of light related to an electrical discharge into a normally non conductive medium, such as air. Not associated with a discharge between two conductive surfaces. Problem associated with a flash of light related to an electrical discharge into a normally non conductive medium, such as air. Not associated with a discharge between two conductive surfaces. C FDA C54451 Medical Device Problem Codes FDA CDRH C62891 1360 Optical Decentration Lens, Decentration Of Problem associated with being off-center of optical lenses. Problem associated with being off-center of optical lenses. C FDA C54451 Medical Device Problem Codes FDA CDRH C62857 1357 Radiation Leak Leak, Radiation Escape of radiation (energy in the form of waves or subatomic particles, especially those that cause ionization) through containment structures, leading to unintended exposure. Escape of radiation (energy in the form of waves or subatomic particles, especially those that cause ionization) through containment structures, leading to unintended exposure. C FDA C54451 Medical Device Problem Codes FDA CDRH C62821 1631 Unexpected Therapeutic Results Therapeutic Results, Unexpected Problem associated with the use of the device for therapeutic purposes. Problem associated with the use of a medical device for therapeutic purposes. C FDA C54451 Medical Device Problem Codes FDA CDRH C62835 1601 Stretched Material Stretched Problem associated with an increase or elongation in a materials' dimension. Problem associated with an increase or elongation in a materials' dimension. C FDA C54451 Medical Device Problem Codes FDA CDRH C62899 2282 No Audible Prompt / Feedback Prompts, No Voice Problem associated with the device ceasing to provide audible prompts. Problem associated with a medical device ceasing to provide audible prompts. C FDA C54451 Medical Device Problem Codes FDA CDRH C62863 1484 Premature Activation Premature System Activation Problem associated with early and unexpected activation of the device. Problem associated with early and unexpected activation of a medical device. C FDA C54451 Medical Device Problem Codes FDA CDRH C62869 1408 Poor Quality Image Monitor, Image Quality Poor Inadequate quality of an image or any visual representation displayed by the device, or output from the device. Inadequate quality of an image or any visual representation displayed by a medical device, or output from the device. C FDA C54451 Medical Device Problem Codes FDA CDRH C62897 2423 Obstruction of Flow Obstruction Problem related to an obstruction or blockage within the device component (e.g. tube, opening, pipe) that results in restriction of flow. Thee circumstance in which a device used for medical purposes fails to perform as intended due to a blocked passage within the device. C FDA C54451 Medical Device Problem Codes FDA CDRH C62849 1248 Restricted Flow rate Flowrate, Restricted Problem associated with flow rate. Flow volume delivered over time is not reaching intended flow rate. Problem associated with flow rate. Flow volume delivered over time is not reaching intended flow rate. C FDA C54451 Medical Device Problem Codes FDA CDRH C62840 1584 Device Slipped Slippage Problem associated with the device moving or sliding from the intended position. Problem associated with a medical device moving or sliding from the intended position. C FDA C54451 Medical Device Problem Codes FDA CDRH C62866 1478 Precipitate in Device or device Ingredient Precipitate Problem associated with the separation of solid particles from a liquid as the result of a chemical or physical change. Problem associated with the separation of solid particles from a liquid as the result of a chemical or physical change. C FDA C54451 Medical Device Problem Codes FDA CDRH C62826 1516 Unable to Obtain Readings Readings, Unable To Obtain The device does not provide or display a valid reading. a medical device does not provide or display a valid reading. C FDA C54451 Medical Device Problem Codes FDA CDRH C62859 1503 Pumping Stopped Pumping, Stopped Unexpected /unintended cessation of pump. Unexpected /unintended cessation of pump. C FDA C54451 Medical Device Problem Codes FDA CDRH C62848 1535 Incorrect, Inadequate or Imprecise Result or Readings Results Incorrect Problem associated with a nonconforming end result, data, or test results provided by the device to its performance specifications. Problem associated with a nonconforming end result, data, or test results provided by a medical device to its performance specifications. C FDA C54451 Medical Device Problem Codes FDA CDRH C62810 1444 Unsealed Device Packaging Packaging, Unsealed Problem associated with the loss of packaging seal. Problem associated with the medical device's loss of packaging seal. C FDA C54451 Medical Device Problem Codes FDA CDRH C62874 1460 Pitted Pitting Problem associated with the corrosion of a material's surface, confined to a point or small area that takes the form of cavities. Problem associated with the corrosion of a material's surface, confined to a point or small area that takes the form of cavities. C FDA C54451 Medical Device Problem Codes FDA CDRH C62831 2385 Tear, Rip or Hole in Device Packaging Packaging, Tears, Rips, Holes In Problem associated with packaging damage (tear, rip or hole) prior to the use of the device. Problem associated with packaging damage (tear, rip or hole) prior to the use of a medical device. C FDA C54451 Medical Device Problem Codes FDA CDRH C62813 1430 Unintended System Motion System Motion, Unintended Problem associated with any motion of the system or components that was not initiated by the user. Problem associated with any motion of the medical device system or components that was not initiated by the user. C FDA C54451 Medical Device Problem Codes FDA CDRH C62819 1429 Unintended Collision Collision, Unintended Problem associated with the device impacting with another object. Problem associated with a medical device impacting with another object. C FDA C54451 Medical Device Problem Codes FDA CDRH C72671 2971 Lack of Maintenance Documentation or Guidelines Problem associated with user facility not receiving adequate service documentation, guidelines, or recommendations to perform preventative and corrective maintenance and performance assurance checks. Problem associated with user facility not receiving adequate service documentation, guidelines, or recommendations to perform preventative and corrective maintenance and performance assurance checks. C FDA C54451 Medical Device Problem Codes FDA CDRH C72674 2930 Environmental Particulates Problem associated with fine solids or liquid particles such as dust, smoke, fume, and/or mist suspended in the immediate atmosphere in which the device is being used. Problem associated with fine solids or liquid particles such as dust, smoke, fume, and/or mist suspended in the immediate atmosphere in which a medical device is being used. C FDA C54451 Medical Device Problem Codes FDA CDRH C67507 3013 Problem with Software Installation Problem associated with installing the device software in a manner that allows full functioning of the device. Source of installation could be manufacturer or user. Problem associated with installing a medical device software in a manner that allows full functioning of a medical device. Source of installation could be manufacturer or user. C FDA C54451 Medical Device Problem Codes FDA CDRH C73117 1643 Inadequate or Insufficient Training Problem associated with facility not providing satisfactory initial and/or periodic user training covering operation of the device. Problem associated with facility not providing satisfactory initial and/or periodic user training covering operation of a medical device. C FDA C54451 Medical Device Problem Codes FDA CDRH C73118 2918 Device Unsafe to Use in Environment Problem associated with environmental condition that results in the unsafe use of the device. (e.g. electromagnetic fields, noise, vibration, microbiological contamination etc.) Problem associated with environmental condition that results in the unsafe use of a medical device. (e.g. electromagnetic fields, noise, vibration, microbiological contamination etc.). C FDA C54451 Medical Device Problem Codes FDA CDRH C76126 2993 Adverse Event Without Identified Device or Use Problem An adverse event (e.g. patient harm) appears to have occurred, but there does not appear to have been a problem with the device or the way it was used. An adverse event appears to have occurred, but there does not appear to have been a problem with a medical device or the way it was used. C FDA C54451 Medical Device Problem Codes FDA CDRH C64243 2994 No Pressure Unintended complete loss of pressure, compromising the device's intended function. Unintended complete loss of pressure, compromising a medical device's intended function. C FDA C54451 Medical Device Problem Codes FDA CDRH C64349 2879 Application Network Problem Problem associated with the deviations from documented system specifications that affects overall system performance and/or the performance of an individual device connected to that system. Problem associated with the deviations from documented system specifications that affects overall system performance and/or the performance of an individual medical device connected to that system. C FDA C54451 Medical Device Problem Codes FDA CDRH C64328 2579 Failure to Form Staple Problem associated with the device failing to connect tissue with a stapling device due to the staples not forming correctly. Problem associated with a medical device failing to connect tissue with a stapling device due to the staples not forming correctly. C FDA C54451 Medical Device Problem Codes FDA CDRH C50554 2933 Expulsion Problem with all or part of an implanted or invasive device being completely expelled from its intended location within the body. Problem with all or part of an implanted or invasive medical device being completely expelled from its intended location within the body. C FDA C54451 Medical Device Problem Codes FDA CDRH C62986 2941 Filtration Problem Problem associated with the process of passing a substance through a porous medium, e.g., a blood clot filter for the removal of suspended matter. Problem associated with the process of passing a substance through a porous medium, e.g., a blood clot filter for the removal of suspended matter. C FDA C54451 Medical Device Problem Codes FDA CDRH C62945 2893 Chemical Problem Problem associated with any from the documented specifications of the device that relate to any chemical characterization, i.e., element, compound, or mixture. Problem associated with any from the documented specifications of a medical device that relate to any chemical characterization, i.e., element, compound, or mixture. C FDA C54451 Medical Device Problem Codes FDA CDRH C62913 1401 Misfocusing The problem relates to the poor focusing of the object or the focus is on the wrong object or in the wrong area. The problem relates to the poor focusing of the object or the focus is on the wrong object or in the wrong area. C FDA C54451 Medical Device Problem Codes FDA CDRH C62903 2990 No Fail-Safe Mechanism The device does not have a fail-safe mechanism, although such mechanism would be required for its appropriate and/or safe functioning. A medical device that does not have a fail-safe mechanism, although such mechanism would be required for its appropriate and/or safe functioning. C FDA C54451 Medical Device Problem Codes FDA CDRH C62910 1405 Moisture Damage Problem associated with damage inflicted upon the device from water vapor or water in the immediate environment in which the device is being used. Problem associated with damage inflicted upon a medical device from water vapor or water in the immediate environment in which a medical device is being used. C FDA C54451 Medical Device Problem Codes FDA CDRH C62922 3022 Temperature Problem Problem associated with the device producing unintended temperatures. Problem associated with a medical device producing unintended temperatures. C FDA C54451 Medical Device Problem Codes FDA CDRH C62957 2912 Device Misassembled During Manufacturing / Shipping A device found incorrectly assembled when delivered to the user facility. A device found incorrectly assembled when delivered to the user facility. C FDA C54451 Medical Device Problem Codes FDA CDRH C62934 3012 Pressure Problem Problem associated with the application of a force either internal or external to device that compromises the flow of fluid or gas. Problem associated with the application of a force either internal or external to device that compromises the flow of fluid or gas. C FDA C54451 Medical Device Problem Codes FDA CDRH C62902 2991 No Flow Problem arising from the device failing to deliver the specified liquid or gas. Problem arising from a medical device failing to deliver the specified liquid or gas. C FDA C54451 Medical Device Problem Codes FDA CDRH C62995 2938 Failure to Auto Stop Problem associated with the inability of device to turn itself off when the device is not in an operable condition. Problem associated with the inability of device to turn itself off when a medical device is not in an operable condition. C FDA C54451 Medical Device Problem Codes FDA CDRH C62988 2939 Failure to Shut Off Problem associated with the device not powering off when a shut down was requested. Problem associated with a medical device not powering off when a shut down was requested. C FDA C54451 Medical Device Problem Codes FDA CDRH C62925 1570 Shipping Damage or Problem Problem associated with shipping damage or problem prior to the use of the device. Problem associated with shipping damage or problem prior to the use of a medical device. C FDA C54451 Medical Device Problem Codes FDA CDRH C62939 3007 Packaging Problem Problem associated with the materials used to construct the cover or outer wrapping of the device. Problem associated with the materials used to construct the cover or outer wrapping of a medical device. C FDA C54451 Medical Device Problem Codes FDA CDRH C62989 2937 Failure of Device to Self-Test Problem associated with the device failing to perform an internal self-diagnostic process to ensure normal operation during or prior to use. Problem associated with a medical device failing to perform an internal self-diagnostic process to ensure normal operation during or prior to use. C FDA C54451 Medical Device Problem Codes FDA CDRH C62914 2532 Misfire Problem associated with a therapy or algorithm not being delivered or executed at the expected time. Problem associated with a therapy or algorithm not being delivered or executed at the expected time. C FDA C54451 Medical Device Problem Codes FDA CDRH C62999 2528 Expiration Date Error Problem associated with errors in identification of expiration date. Problem associated with errors in identification of expiration date. C FDA C54451 Medical Device Problem Codes FDA CDRH C62997 2936 Fail-Safe Problem Problem associated with the feature that prevents the unsafe use of the device. Problem associated with the feature that prevents the unsafe use of a medical device. C FDA C54451 Medical Device Problem Codes FDA CDRH C62931 1525 Device Remains Activated Problem associated with the device continuing to be in an active state after deactivation was requested. Problem associated with a medical device continuing to be in an active state after deactivation was requested. C FDA C54451 Medical Device Problem Codes FDA CDRH C62941 3005 Output Problem Problem associated with any deviation from the documented specifications of the device that relate to the end result, data, or test results provided by the device. Problem associated with any deviation from the documented specifications of a medical device that relate to the end result, data, or test results provided by a medical device. C FDA C54451 Medical Device Problem Codes FDA CDRH C62953 3001 Optical Problem Problem associated with transmission of visible light affecting the quality of the image transmitted or otherwise affecting the intended application of the visible light path. Problem associated with transmission of visible light affecting the quality of the image transmitted or otherwise affecting the intended application of the visible light path. C FDA C54451 Medical Device Problem Codes FDA CDRH C62909 2986 Moisture or Humidity Problem Problem associated with an unsatisfactory humidity level in the storage or use environment which affects the device performance. Problem associated with an unsatisfactory humidity level in the storage or use environment which affects a medical device performance. C FDA C54451 Medical Device Problem Codes FDA CDRH C62968 2978 Material Integrity Problem Problem associated with any deviations from the documented specifications of the device that relate to the limited durability of all material used to construct device. Problem associated with any deviations from the documented specifications of a medical device that relate to the limited durability of all material used to construct the device. C FDA C54451 Medical Device Problem Codes FDA CDRH C63307 2878 Ambient Temperature Problem Problem associated with compromised device performance at the ambient temperature or the storage at an inappropriate ambient temperature. Problem associated with compromised medical device performance at the ambient temperature or the storage at an inappropriate ambient temperature. C FDA C54451 Medical Device Problem Codes FDA CDRH C63270 2898 Computer Operating System Problem Problem associated with software, firmware, and/or hardware elements that control the execution of computer programs and provides such services as computer resource allocation, job control, input/output control, and file management in a computer system. Problem associated with software, firmware, and/or hardware elements that control the execution of computer programs and provides such services as computer resource allocation, job control, input/output control, and file management in a computer system. C FDA C54451 Medical Device Problem Codes FDA CDRH C63235 2920 Difficult to Advance Problem associated with difficulty moving the device to an intended location (e.g. difficulty in advancing guide wire). Problem associated with difficulty moving a medical device to an intended location (e.g. difficulty in advancing guide wire). C FDA C54451 Medical Device Problem Codes FDA CDRH C63221 1181 Display Difficult to Read 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. Problem associated with legibility of the medical 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. C FDA C54451 Medical Device Problem Codes FDA CDRH C63300 1036 Signal Artifact Problem associated with impurities or interference in a signal (e.g. ECG artifact). Problem associated with impurities or interference in a signal (e.g. ECG artifact). C FDA C54451 Medical Device Problem Codes FDA CDRH C63231 2922 Difficult to Open or Remove Packaging Material Problem associated with difficulty for users to operate the device, specifically as it relates to the opening or removal of the outer wrapping. Problem associated with difficulty for users to operate a medical device, specifically as it relates to the opening or removal of the outer wrapping. C FDA C54451 Medical Device Problem Codes FDA CDRH C63258 2902 Data Back-Up Problem Problems relating to a system, component, file, procedure, or person available to replace or help restore a primary item in the event of a failure or externally caused disaster. Problems relating to a system, component, file, procedure, or person available to replace or help restore a primary item in the event of a failure or externally caused disaster. C FDA C54451 Medical Device Problem Codes FDA CDRH C63238 2917 Device Sensing Problem Problem associated with the device feature that are designed to respond to a physical stimulus (temperature, illumination, motion, cardiac rhythms) and that do not transmit a resulting signal for interpretation or measurement. Problem associated with a medical device feature that are designed to respond to a physical stimulus (temperature, illumination, motion, cardiac rhythms) and that do not transmit a resulting signal for interpretation or measurement. C FDA C54451 Medical Device Problem Codes FDA CDRH C63216 2926 Electrical Shorting Problem associated with an electric current travelling along an accidental path (unintended path) in a circuit. Problem associated with an electric current travelling along an accidental path (unintended path) in a circuit of a medical device. C FDA C54451 Medical Device Problem Codes FDA CDRH C63202 2932 Excessive Cooling Problem associated with the device producing temperatures that are lower than specified. Problem associated with a medical device producing temperatures that are lower than specified. C FDA C54451 Medical Device Problem Codes FDA CDRH C63305 2880 Application Program Problem Problem associated with the requirement for software to fulfill its function within an intended use or application. Problem associated with the requirement for software to fulfill its function within an intended use or application. C FDA C54451 Medical Device Problem Codes FDA CDRH C63217 2925 Electrical Power Problem Problem associated with the quality of the facility-supplied power. Problem associated with the quality of the facility-supplied power to the medical device. C FDA C54451 Medical Device Problem Codes FDA CDRH C63298 1441 Pacing Asynchronously Problem associated with a pacing transmission process such that between any two significant instants in the same group, there is always an integral number of unit intervals. Between two significant instants located in different groups, there are not always an integral number of unit intervals. Problem associated with a pacing transmission process such that between any two significant instants in the same group, there is always an integral number of unit intervals. Between two significant instants located in different groups, there are not always an integral number of unit intervals. C FDA C54451 Medical Device Problem Codes FDA CDRH C63304 2881 Application Program Version or Upgrade Problem Problem associated with installing updates to a software system that affects the device performance or communication with another device. Problem associated with installing updates to a software system that affects a medical device performance or communication with another device. C FDA C54451 Medical Device Problem Codes FDA CDRH C63215 2927 Electromagnetic Compatibility Problem Problem associated with the ability of a system to function in its electromagnetic environment without introducing intolerable disturbances to anything in its environment. Problem associated with the ability of a system to function in its electromagnetic environment without introducing intolerable disturbances to anything in its environment. C FDA C54451 Medical Device Problem Codes FDA CDRH C63256 1145 Decoupling Problem associated with the device being unassociated in such a way that fluid, gas, power or signal information may not be transferred from one to another. Problem associated with a medical device being unassociated in such a way that fluid, gas, power or signal information may not be transferred from one device to another. C FDA C54451 Medical Device Problem Codes FDA CDRH C63213 2149 Electro-Static Discharge Problem associated with the discharge of electricity between two bodies previously electrically charged. Problem associated with the discharge of electricity between two bodies previously electrically charged in a medical device. C FDA C54451 Medical Device Problem Codes FDA CDRH C63294 2886 Biocompatibility Problem associated with undesirable local or systemic effects due to exposure to medical device materials or leachates from those materials by a patient who has an implant or is receiving treatment with a device made from them. Problem associated with undesirable local or systemic effects due to exposure to medical device materials or leachates from those materials by a patient who has an implant or is receiving treatment with a device made from them. C FDA C54451 Medical Device Problem Codes FDA CDRH C63138 1634 Tidal Volume Fluctuations Problem associated with the amount of gas that is inspired and expired during one respiratory cycle. Problem associated with the amount of gas that is inspired and expired during one respiratory cycle. C FDA C54451 Medical Device Problem Codes FDA CDRH C63283 1079 Capacitative Coupling Problem associated with the transfer of energy within an electrical network by means of the capacitance between circuit nodes. It occurs when energy is coupled from one circuit to another through an electric field. Problem associated with the transfer of energy within an electrical network by means of the capacitance between circuit nodes. It occurs when energy is coupled from one circuit to another through an electric field. C FDA C54451 Medical Device Problem Codes FDA CDRH C63277 1089 Circuit Failure Problem associated with a failure of the internal network paths or electrical circuitry (i.e. electrical components, circuit boards, wiring). Problem associated with a failure of the internal network paths or electrical circuitry (i.e. electrical components, circuit boards, wiring). C FDA C54451 Medical Device Problem Codes FDA CDRH C63265 1123 Continuous Firing Problem associated with the excessive production of electrical impulses over a period. Problem associated with the excessive production of electrical impulses over a period. C FDA C54451 Medical Device Problem Codes FDA CDRH C63267 2956 Inadequate Instructions for Non-Healthcare Professional Problem associated with users being unclear and not able to follow any written, printed, or graphic matter that is affixed to device or its packaging with any matter that accompanies the device including verbal instructions related to identification, technical description and use of the device provided by the device manufactures that vary from the standard of medical care in a given environment. Problem associated with users being unclear and not able to follow any written, printed, or graphic matter that is affixed to device or its packaging with any matter that accompanies a medical device including verbal instructions related to identification, technical description and use of the device provided by a medical device manufacturer that vary from the standard of medical care in a given environment. C FDA C54451 Medical Device Problem Codes FDA CDRH C63308 2877 Ambient Noise Problem Problem associated with any undesired acoustic energy or vibration that tends to interfere with the operation of the device. Problem associated with any undesired acoustic energy or vibration that tends to interfere with the operation of a medical device. C FDA C54451 Medical Device Problem Codes FDA CDRH C63271 2896 Communication or Transmission Problem Problem associated with the device sending or receiving signals or data. This includes transmission among internal components of the device to which the device is intended to communicate. Problem associated with a medical device sending or receiving signals or data. This includes transmission among internal components of a medical device to which a medical device is intended to communicate. C FDA C54451 Medical Device Problem Codes FDA CDRH C63309 1022 Alarm Not Visible The device does not display an alarm message when required. A medical device does not display an alarm message when required. C FDA C54451 Medical Device Problem Codes FDA CDRH C63303 2289 Arcing of Electrodes Problem associated with electrical current flowing through a gap between electrodes (conductive surfaces), typically resulting in a visible flash of light. Problem associated with electrical current flowing through a gap between electrodes (conductive surfaces), typically resulting in a visible flash of light. C FDA C54451 Medical Device Problem Codes FDA CDRH C63302 1032 Arcing at Paddles Problem associated with electrical current flowing through a gap between paddles (conductive surfaces), typically resulting in a visible flash of light. Problem associated with electrical current flowing through a gap between paddles (conductive surfaces), typically resulting in a visible flash of light. C FDA C54451 Medical Device Problem Codes FDA CDRH C63205 2591 Device Displays Incorrect Message Problem associated with providing incorrect display information. Problem associated with providing incorrect display information in a medical device. C FDA C54451 Medical Device Problem Codes FDA CDRH C63301 2583 Arcing Problem associated with electrical current flowing through a gap between two conductive surfaces, typically resulting in a visible flash of light. Problem associated with electrical current flowing through a gap between two conductive surfaces, typically resulting in a visible flash of light. C FDA C54451 Medical Device Problem Codes FDA CDRH C63218 2924 Electrical Overstress Problem associated with an electrical activity that exceeded the specified threshold limit of the internal integrated circuitry. Problem associated with electrical activity of a medical device that exceeded the specified threshold limit of the internal integrated circuitry. C FDA C54451 Medical Device Problem Codes FDA CDRH C63209 2929 Environmental Compatibility Problem Problem associated with the surrounding conditions in which the device is being used such as temperature, noise, lighting, ventilation, or other external factors such as power supply. Problem associated with the surrounding conditions in which a medical device is being used such as temperature, noise, lighting, ventilation, or other external factors such as power supply. C FDA C54451 Medical Device Problem Codes FDA CDRH C63135 1253 Fogging Problem associated with the visibility of water vapor in the immediate atmosphere in which the device is being used. Problem associated with the visibility of water vapor in the immediate atmosphere in which a medical device is being used. C FDA C54451 Medical Device Problem Codes FDA CDRH C63130 2945 Free or Unrestricted Flow Problem associated with uncontrolled flow of infusion of air, gas or fluids. Problem associated with uncontrolled flow of infusion of air, gas or fluids. C FDA C54451 Medical Device Problem Codes FDA CDRH C63290 1064 Backflow Continuous flow of fluid (e.g. liquid, gas) against the intended flow direction. Continuous flow of fluid (e.g. liquid, gas) against the intended flow direction. C FDA C54451 Medical Device Problem Codes FDA CDRH C63126 1270 Gradient Increase Problem associated with the increased rate of change in temperature, pressure, or other variables as a function of distance, time, etc. Problem associated with the increased rate of change in temperature, pressure, or other variables as a function of distance, time, etc. C FDA C54451 Medical Device Problem Codes FDA CDRH C63065 1558 Sensing Intermittently Problem with the device receiving an incoming signal on an intermittent basis when expected to be continuous. Problem with a medical device receiving an incoming signal on an intermittent basis when expected to be continuous. C FDA C54451 Medical Device Problem Codes FDA CDRH C63040 2982 Measurement System Incompatibility Problem associated with the incompatibility of the measurement systems between and/or within device systems that are inherent to the individual device thereby leading to miscalculated or mismatched measurements from those devices, e.g., international metric system versus U.S. measurement system. Problem associated with the incompatibility of the measurement systems between and/or within device systems that are inherent to the individual device thereby leading to miscalculated or mismatched measurements from those devices, e.g., international metric system versus U.S. measurement system. C FDA C54451 Medical Device Problem Codes FDA CDRH C63041 2975 Manufacturing, Packaging or Shipping Problem Problem associated with any deviations from the documented specifications of the device that relate to nonconformity during manufacture to the design of an item or to specified manufacturing, packaging or shipping processes (out of box problem). Problem associated with any deviations from the documented specifications of a medical device that relate to nonconformity during manufacture to the design of an item or to specified manufacturing, packaging or shipping processes (out of box problem). C FDA C54451 Medical Device Problem Codes FDA CDRH C63144 1233 Filling Problem Problem associated with the method or amount of time associated with the delivery of a fluid. Time to delivery or amount of delivered entity may be affected. Problem associated with the method or amount of time associated with the delivery of a fluid. Time to delivery or amount of delivered entity may be affected. C FDA C54451 Medical Device Problem Codes FDA CDRH C63111 2952 Improper Chemical Reaction Problem associated with an unexpected or incomplete chemical reaction or effect. Problem associated with an unexpected or incomplete chemical reaction or effect. C FDA C54451 Medical Device Problem Codes FDA CDRH C63127 2946 Gas Leak Problem associated with the unintended escape of a gas from the container in which it is housed. Problem associated with the unintended escape of a gas from the container in which it is housed. C FDA C54451 Medical Device Problem Codes FDA CDRH C63090 2507 Incomplete Coaptation Problem associated with the heart valve leaflet not closing properly. Problem associated with the heart valve leaflet not closing properly. C FDA C54451 Medical Device Problem Codes FDA CDRH C63020 2897 Component or Accessory Incompatibility Problem associated with the incompatibility of any device while being operated in the same use environment thereby leading to a dysfunction between the devices. Problem associated with the incompatibility of any device while being operated in the same use environment thereby leading to a dysfunction between a medical devices. C FDA C54451 Medical Device Problem Codes FDA CDRH C63027 2891 Capturing Problem Problem associated with the inability of the device to achieve successful depolarization and contraction of a cardiac chamber caused by a pacemaker output pulse. Problem associated with the inability of a medical device to achieve successful depolarization and contraction of a cardiac chamber caused by a pacemaker output pulse. C FDA C54451 Medical Device Problem Codes FDA CDRH C63075 2964 Infusion or Flow Problem Problem associated with the device failing to deliver liquids or gases as intended (e.g. delivering drugs at incorrect rate, Problems with drawing fluid from a system.) Problem associated with a medical device failing to deliver liquids or gases as intended (e.g. delivering drugs at incorrect rate, problems with drawing fluid from a system.) C FDA C54451 Medical Device Problem Codes FDA CDRH C63066 1443 Pacing Intermittently Problem associated with the failure of pacing device for a limited period of time, following which the item recovers its ability to perform its required function without being subjected to any external corrective action. Note: such as failure is often recurrent. Problem associated with the failure of pacing device for a limited period of time, following which the item recovers its ability to perform its required function without being subjected to any external corrective action. Note: such as failure is often recurrent. C FDA C54451 Medical Device Problem Codes FDA CDRH C63030 2885 Battery Problem Problem associated with the internal power of the device (e.g. battery, transformer, fuel cell or other power sources). Problem associated with the internal power of a medical device (e.g. battery, transformer, fuel cell or other power sources). C FDA C54451 Medical Device Problem Codes FDA CDRH C63026 2892 Charging Problem Problem associated with the inability of the device to successfully charge an electrical source. Problem associated with the inability of a medical device to successfully charge an electrical source. C FDA C54451 Medical Device Problem Codes FDA CDRH C63140 2942 Flare or Flash Problem associated with device-related burn with an unsteady flame. Problem associated with a medical device-related burn with an unsteady flame. C FDA C54451 Medical Device Problem Codes FDA CDRH C63002 1431 Energy Output Problem Problem with the device's intended output of energy. Problem with a medical device's intended output of energy. C FDA C54451 Medical Device Problem Codes FDA CDRH C63117 1304 Image Display Error / Artifact Problem with image display leading to corrupted images or readouts/measurement indications. Problem with image display leading to corrupted images or readouts/measurement indications. C FDA C54451 Medical Device Problem Codes FDA CDRH C63113 1307 Imprecision Problem associated with the device providing imprecise measurements when compared to a reference standard. Problem associated with a medical device providing imprecise measurements when compared to a reference standard. C FDA C54451 Medical Device Problem Codes FDA CDRH C63114 2950 Impedance Problem Problem associated with electrical impedance levels between device and patient connections. Problem associated with electrical impedance levels between device and patient connections. C FDA C54451 Medical Device Problem Codes FDA CDRH C63100 2958 Inadequate User Interface Problem associated with the means by which the operator and the equipment communicate or interact. Problem associated with the means by which the operator and the equipment communicate or interact. C FDA C54451 Medical Device Problem Codes FDA CDRH C63125 1271 Grounding Malfunction Problem associated with the inability to connect conductors of an electronic system for the purpose of controlling or impeding ground currents and voltages. Problem associated with the inability to connect conductors of an electronic system for the purpose of controlling or impeding ground currents and voltages. C FDA C54451 Medical Device Problem Codes FDA CDRH C63000 1210 Energy Spectrum Incorrect Problem associated with the energy output from the device not being in the expected part of the spectrum. Problem associated with the energy output from a medical device not being in the expected part of the spectrum. C FDA C54451 Medical Device Problem Codes FDA CDRH C63097 1442 Pacing Inadequately Pacing voltage or pulse width is less than desired. Pacing voltage or pulse width is less than desired. C FDA C54451 Medical Device Problem Codes FDA CDRH C63004 1425 Device Emits Odor Problem associated with an unexpected or inappropriate smell released by the device. Problem associated with an unexpected or inappropriate smell released by a medical device. C FDA C54451 Medical Device Problem Codes FDA CDRH C63013 2906 Activation, Positioning or Separation Problem 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". 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. C FDA C54451 Medical Device Problem Codes FDA CDRH C63025 3010 Power Problem Problem associated with the energy to operate the device. Problem associated with the energy to operate a medical device. C FDA C54451 Medical Device Problem Codes FDA CDRH C63028 2890 Calibration Problem Problem associated with the operation of the device, related to its accuracy, and associated with the calibration of the device. Problem associated with the operation of a medical device, related to its accuracy, and associated with the calibration of a medical device. C FDA C54451 Medical Device Problem Codes FDA CDRH C79146 3134 Device Difficult to Maintain Problem associated with the user's ability to service the device according to the manufacturer specifications relating to the device routine maintenance, i.e., periodic inspection, failure detection, repair, and care of the device to sustain or restore acceptable operating conditions. Problem associated with the user's ability to service a medical device according to the manufacturer specifications relating to a routine device maintenance, i.e., periodic inspection, failure detection, repair, and care of the device to sustain or restore acceptable operating conditions. C FDA C54451 Medical Device Problem Codes FDA CDRH C79147 3133 Misassembly by Users Problem associated with incorrect assembly of the device or constituents by the users. Problem associated with incorrect assembly of a medical device or constituents by the users. C FDA C54451 Medical Device Problem Codes FDA CDRH C95875 3266 High Capture Threshold Capture Threshold, High Problem with the amount of output energy needed to cause cardiac depolarization being higher than expected/desired. Problem with the amount of output energy needed to cause cardiac depolarization being higher than expected/desired. C FDA C54451 Medical Device Problem Codes FDA CDRH C95876 3269 Unstable Capture Threshold Capture Threshold, Unstable Problem with the amount of output energy needed to cause cardiac depolarization being unstable. Problem with the amount of output energy needed to cause cardiac depolarization being unstable. C FDA C54451 Medical Device Problem Codes FDA CDRH C95878 3267 Missing Test Results Test Results, Missing Problem associated with the results of a test or measurement not appearing. Problem associated with the results of a test or measurement not appearing. C FDA C54451 Medical Device Problem Codes FDA CDRH C72887 2985 Medical Gas Supply Problem Problem associated with the facility-supplied medical gases such as medical air, oxygen, nitrous oxide, and nitrogen. Problem associated with the facility-supplied medical gases such as medical air, oxygen, nitrous oxide, and nitrogen. C FDA C54451 Medical Device Problem Codes FDA CDRH C72893 3018 Radiation Underexposure Problem associated with too little radiation emitted from radiological or diagnostic devices. Problem associated with too little radiation emitted from radiological or diagnostic devices. C FDA C54451 Medical Device Problem Codes FDA CDRH C72892 3017 Radiation Overexposure Problem associated with excessive radiation emitted from radiological or diagnostic devices. Problem associated with excessive radiation emitted from radiological or diagnostic devices. C FDA C54451 Medical Device Problem Codes FDA CDRH C72890 3006 Overcorrection Problem associated with an adjustment that surpasses a set of criteria. Problem associated with an adjustment that surpasses a set of criteria. C FDA C54451 Medical Device Problem Codes FDA CDRH C72891 2979 Material Protrusion / Extrusion Problem associated with undesired physical appearance of device material, specifically when material extends beyond or above device surface. Problem associated with undesired physical appearance of device material, specifically when material extends beyond or above device surface. C FDA C54451 Medical Device Problem Codes FDA CDRH C62842 1568 Shielding Failure Problem associated with the device inability to act as a barrier for absorption of radiation energy in X-rays, gamma rays, etc. Problem associated with a medical device inability to act as a barrier for absorption of radiation energy in X-rays, gamma rays, etc. C FDA C54451 Medical Device Problem Codes FDA CDRH C62861 2281 Visual Prompts will not Clear Problem with visual messages which continue to be displayed on / by the device after the appropriate action has been taken. Problem with visual messages which continue to be displayed on/by a medical device after the appropriate action has been taken. C FDA C54451 Medical Device Problem Codes FDA CDRH C62888 3002 Optical Obstruction Problem associated with the blocking of optical devices, e.g. visual pathways. Problem associated with the blocking of optical devices, e.g. visual pathways. C FDA C54451 Medical Device Problem Codes FDA CDRH C62884 2404 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". 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. C FDA C54451 Medical Device Problem Codes FDA CDRH C62827 1656 Inadequate Ultra Filtration Problem associated with the transfer of fluid between the blood and dialysate through the dialysis membrane due to a pressure gradient (trans-membrane pressure) existing between the blood and dialysate compartments. Problem associated with the transfer of fluid between the blood and dialysate through the dialysis membrane due to a pressure gradient (trans-membrane pressure) existing between the blood and dialysate compartments. C FDA C54451 Medical Device Problem Codes FDA CDRH C62881 1438 Over-Sensing Problem related to failure of the device to properly filter cardiac signals resulting in inappropriate device response. A difficulty with a medical device detecting unintended signals. C FDA C54451 Medical Device Problem Codes FDA CDRH C62811 1664 Unraveled Material Problem due to the undesired unravelling of material (e.g. disentangled, unwound etc.). Problem due to the medical device's undesired unravelling of material (e.g. disentangled, unwound etc.). C FDA C54451 Medical Device Problem Codes FDA CDRH C62806 1674 Vibration Problem associated with the undesirable mechanical oscillation. Problem associated with the undesirable mechanical oscillation in a medical device. C FDA C54451 Medical Device Problem Codes FDA CDRH C62830 1629 Telemetry Discrepancy Problem associated with variability of the transmission of telemetry signals. Problem associated with variability of the transmission of telemetry signals. C FDA C54451 Medical Device Problem Codes FDA CDRH C62809 1667 Unstable Problem associated with the mechanical stability of the device. Problem associated with the mechanical stability of a medical device. C FDA C54451 Medical Device Problem Codes FDA CDRH C62886 3003 Osseointegration Problem Problem associated with interconnection between the bone tissue and the implanted device. Problem associated with interconnection between the bone tissue and the implanted device. C FDA C54451 Medical Device Problem Codes FDA CDRH C62860 3016 Pumping Problem Problem associated with pump performance deviating from specifications in a way to compromise flow or infusion. Problem associated with pump performance deviating from specifications in a way to compromise flow or infusion. C FDA C54451 Medical Device Problem Codes FDA CDRH C62841 1575 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". 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. C FDA C54451 Medical Device Problem Codes FDA CDRH C62887 1305 Image Orientation Incorrect Problem associated with an incorrect image orientation on the device display. Problem associated with an incorrect image orientation on a medical device display. C FDA C54451 Medical Device Problem Codes FDA CDRH C62822 1661 Under-Sensing Problem related to failure of the device to properly detect intrinsic cardiac activity and respond appropriately. A difficulty with a medical device not detecting a signal at the intended threshold. C FDA C54451 Medical Device Problem Codes FDA CDRH C62889 3000 Optical Distortion Problem associated with an optical defect in an image-forming system whereby the image is not the shape of an ideal image of the object. Problem associated with an optical defect in an image-forming system whereby the image is not the shape of an ideal image of the object. C FDA C54451 Medical Device Problem Codes FDA CDRH C62853 1524 Device Appears to Trigger Rejection The device appears to elicit undesired response in the patient to the presence of an implanted or invasive device, without inherent device failure, e.g. fibrous encapsulation, or inflammation of the tissue around the device, or extrusion of the device. A medical device appears to elicit undesired response in the patient to the presence of an implanted or invasive device, without inherent device failure, e.g. fibrous encapsulation, or inflammation of the tissue around a medical device, or extrusion of a medical device. C FDA C54451 Medical Device Problem Codes FDA CDRH C62852 3019 Reset Problem Problem associated with setting a variable, register, or other storage location back to a prescribed state. Problem associated with setting a variable, register, or other storage location back to a prescribed state. C FDA C54451 Medical Device Problem Codes FDA CDRH C62898 1420 Nonstandard device Problem associated with the device that does not meet the specifications or requirements for which it was manufactured (e.g. materials, parts, manufacturing process). Problem associated with a medical device that does not meet the specifications or requirements for which it was manufactured (e.g. materials, parts, manufacturing process). C FDA C54451 Medical Device Problem Codes FDA CDRH C62858 1508 Therapy Delivered to Incorrect Body Area Problem associated with the device causing unintended therapeutic action to an area of the body other than the intended area. Problem associated with a medical device causing unintended therapeutic action to an area of the body other than the intended area. C FDA C54451 Medical Device Problem Codes FDA CDRH C62838 2324 Solder Joint Fracture Problem associated with undesired damage or breakage in a solder joint of materials used in the device construction. Problem associated with undesired damage or breakage in a solder joint of materials used in a medical device construction. C FDA C54451 Medical Device Problem Codes FDA CDRH C62807 3027 Ventilation Problem in Device Environment Problem associated with the circulation of fresh air in the immediate atmosphere in which the device is being used. Problem associated with the circulation of fresh air in the immediate atmosphere in which a medical device is being used. C FDA C54451 Medical Device Problem Codes FDA CDRH C62878 1454 Peeled / Delaminated Peeling or delamination of composite materials, including coatings, that occurs when layers are separated as a result of stress or impact and resulting in loss of mechanical toughness. Peeling or delamination of composite materials in a medical device, including coatings, that occurs when layers are separated as a result of stress or impact and resulting in loss of mechanical toughness. C FDA C54451 Medical Device Problem Codes FDA CDRH C62880 1440 Pacemaker Found in Back-Up Mode A device with a pacing function found in back-up Mode. This may be an appropriate fail-safe action (e.g. end of battery life), or be caused by device-malfunction or due to operator error. A device with a pacing function found in back-up mode. This may be an appropriate fail-safe action (e.g. end of battery life), or be caused by device-malfunction or due to operator error. C FDA C54451 Medical Device Problem Codes FDA CDRH C62855 2314 Radiofrequency Interference (RFI) Problem associated with the degradation of the reception of a wanted signal caused by RF disturbance. Problem associated with the degradation of the reception of a wanted signal caused by RF disturbance. C FDA C54451 Medical Device Problem Codes FDA CDRH C62894 2996 Operating System Becomes Nonfunctional Problem associated with malfunction of the computer operating system as opposed to an application software problem. Problem associated with malfunction of the computer operating system as opposed to an application software problem. C FDA C54451 Medical Device Problem Codes FDA CDRH C62828 3023 Therapeutic or Diagnostic Output Failure Problem associated with the failure of the device to deliver the output required for treatment or identification of a disease. Problem associated with the failure of a medical device to deliver the output required for treatment or identification of a disease. C FDA C54451 Medical Device Problem Codes FDA CDRH C62890 2999 Optical Discoloration Problem associated with an undesired change of color. Problem associated with an undesired change of color. C FDA C54451 Medical Device Problem Codes FDA CDRH C62865 3011 Premature Indicator Activation Problems with the activation of a protective measure indicator earlier than expected. Problems with the activation of a protective measure indicator earlier than expected. C FDA C54451 Medical Device Problem Codes FDA CDRH C62879 1451 Particulates Substances that consist of separate particles that are introduced by the device during use. Substances that consist of separate particles that are introduced by a medical device during use. C FDA C54451 Medical Device Problem Codes FDA CDRH C62872 1463 Pocket Stimulation Problem associated with a pocket of skin in which the pulse generator is housed. Problem associated with a pocket of skin in which the pulse generator is housed. C FDA C54451 Medical Device Problem Codes FDA CDRH C62893 2997 Operating System Version or Upgrade Problem Problem associated with replacing an older operating system to an up-to-date operating system. Problem associated with replacing an older operating system to an up-to-date operating system. C FDA C54451 Medical Device Problem Codes FDA CDRH C62868 1474 Power Conditioning Problem Problem associated with a momentary overpower/over voltage from the utility and electrical systems of user facilities; - Problem associated with inadequate power conditioning such as the presence of fluctuation, surges, spikes, dropouts, noise and other such undesirable transients. Problem associated with a momentary overpower/over voltage from the utility and electrical systems of user facilities; or inadequate power conditioning such as the presence of fluctuation, surges, spikes, dropouts, noise and other such undesirable transients. C FDA C54451 Medical Device Problem Codes FDA CDRH C76121 2949 Human-Device Interface Problem Problem associated with an act or omission of an act that has a different result than that intended by the manufacturer or expected by the operator. Problem associated with an act or omission of an act that has a different result than that intended by the manufacturer or expected by the operator. C FDA C54451 Medical Device Problem Codes FDA CDRH C96715 3270 Activation Failure Including Expansion Failures Problem associated with the device failing to be activated including expansion. Problem associated with a medical device failing to be activated including expansion. C FDA C54451 Medical Device Problem Codes FDA CDRH C63276 2895 Contamination / decontamination Problem 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. Problem associated with the presence of any unexpected foreign substance found in a medical 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. C FDA C54451 Medical Device Problem Codes FDA CDRH C95879 3265 Device Handling Problem Handling of the device not in accordance with specification, prior to use on the patient. Handling of a medical device not in accordance with specifications. C FDA C54451 Medical Device Problem Codes FDA CDRH C95877 3268 No Pacing Problem associated with the device ceasing to deliver paces. Problem associated with a medical device ceasing to deliver paces. C FDA C54451 Medical Device Problem Codes FDA CDRH C91396 3198 Application Program Problem: Medication Error Event in which the device software results in errors of medication preparation or administration. An error in medication preparation or administration attributed to software. C FDA C54451 Medical Device Problem Codes FDA CDRH C91398 3197 Patient Data Problem Event in which data is accessed by the healthcare provider and either the wrong patient or the wrong data is retrieved despite correct inquiry procedures. The retrieval of incorrect data about a particular patient. C FDA C54451 Medical Device Problem Codes FDA CDRH C91397 3196 Data Problem Event in which data (charting, orders, results) is not correctly stored, transferred, updated, or displayed. Incorrect transfer, storage, display or updating of data. C FDA C54451 Medical Device Problem Codes FDA CDRH C104820 3283 Wireless Communication Problem Problems with the RF wireless technology characteristics and performance (e.g., frequency, output power, range, reception), wireless quality of service, wireless coexistence, security of wireless signals and data, and electromagnetic compatibility. Any issue that impedes communication with a medical device that can be attributed to the wireless function.