BEUDAMED
    FDA Adverse Event Death Summary report: N

    MFE, MULTIFUNCTION ELECTRODE, ADAPTER, PHILLIPS PLUG AED

    MDR report key: 3102285 · Received May 9, 2013

    Report

    Report Number
    1320894-2013-00047
    Event Type
    Death
    Date Received
    May 9, 2013
    Date of Event
    April 12, 2013
    Report Date
    July 31, 2013
    Manufacturer
    CONMED CORPORATION
    Product Code
    MKJ
    PMA / PMN Number
    K020288
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    CORRECTED DATA: FROM THE PHOTOGRAPH OF THE DEVICE SENT BY THE REPORTER OF THE INCIDENT IT WAS DISCOVERED THAT THE LOT NUMBER OF THE DEVICE IS 0509271. THE ORIGINAL REPORTED MANUFACTURE DATE WAS 05/27/2005. FROM THE LOT NUMBER THE PROPER DATE OF MANUFACTURE IS 09/27/2005. THE DEVICE IN QUESTION IS A PADPRO ADAPTOR UTILIZED TO CONVEY THE ELECTRICAL CURRENT OF A DEFIBRILLATOR TO AND FROM THE MULTI-FUNCTION ELECTRODES. A REVIEW OF THE MANUFACTURING DOCUMENTS FROM THE DHR/LHR, DEVICE HISTORY RECORD/LOT HISTORY RECORD, FOR LOT 0509271 HAS VERIFIED THE DEVICES WERE PRODUCED ACCORDING TO CURRENT AND APPROVED PROCEDURES AND MATERIAL SPECIFICATIONS. NON-CONFORMANCES REGARDING THE PRODUCT'S IDENTITY, QUALITY, SAFETY, EFFECTIVENESS OR PERFORMANCE WERE NOT IDENTIFIED DURING MANUFACTURE. NO DEVICES WERE REJECTED DURING THE MANUFACTURING PRODUCTION TESTING. A 24-MONTH REVIEW OF THE CUSTOMER COMPLAINT HISTORY FOR PADPRO ADAPTER, CATALOG NUMBER HP4R, HAS SHOWN THIS AS AN ISOLATED INCIDENT FOR THIS REPORTED FAILURE MODE.. THE COMPLAINT PRODUCT IS BEING HELD BY (B)(6) MEMORIAL HOSPITAL RISK MANAGEMENT DEPARTMENT, AND, IS NOT BEING RETURNED TO CONMED COMPLAINT HANDLING CENTER FOR INVESTIGATION. THEREFORE, THE ROOT CAUSE OF THE FAILURE MODE CANNOT BE CONCLUSIVELY DETERMINED AT THIS TIME. DURING THE MANUFACTURING PROCESS 100% OF THESE DEVICES UNDERGO ELECTRICAL RESISTANCE/CONTINUITY TESTING, AS WELL AS HIGH POTENTIAL TESTING. ANY DEVICE THAT DOES NOT MEET TESTING PARAMETERS MUST BE SCRAPPED. THE DFU, DIRECTIONS FOR USE, FOR THE DEVICE STATES, "BEFORE USE OF THE CONMED PADPRO ADAPTER, INSPECT THE CONDITION OF THE ADAPTER. IF CRACKED, DAMAGED OR LOOSE, DISCARD AND REPLACE WITH A NEW ADAPTER." IT IS THE END-USER'S RESPONSIBILITY TO INSPECT AND MAINTAIN A FUNCTIONAL ADAPTOR AND/OR HAVE REPLACEMENTS IN THE EVENT THAT AN ADAPTOR DEVELOPS THE INABILITY TO FUNCTION OVER TIME. THERE IS NO SPECIFIC SHELF LIFE FOR THE PRODUCT; HOWEVER, THE REPEATED USE OF THE DEVICE OVER TIME CAN REASONABLY RESULT IN THE EVENTUAL LOSS OF FUNCTION BY BREACH OF THE WIRE, CRACKS, OR BENT PRONG, SECONDARY TO THE END-USER'S REPEATED USE. AN HHE, HEALTH HAZARD EVALUATION WAS CONDUCTED TO EVALUATE THE RISKS ASSOCIATED WITH THIS FAILURE MODE. THE HHE HAS CONCLUDED THAT THERE IS NO RISK TO HEALTH; THEREFORE, CORRECTIVE ACTIONS ARE NOT WARRANTED AT THIS TIME. CONMED IS CONSIDERING THIS COMPLAINT CLOSED. THIS MEDWATCH IS ASSOCIATED WITH AN END-USER SUBMITTED MEDWATCH; HOWEVER, THE SOFTWARE STATES THAT THE END-USER FACILITY NUMBER IS NOT A PROPER NUMBER AND WILL NOT TAKE THE UF REPORTER #. (B)(4).

    Additional Manufacturer Narrative · 1

    THE SUSPECT DEVICE IS BEING RETAINED BY THE RISK MANAGEMENT DEPARTMENT OF THE END-USER FACILITY; THEREFORE, EVALUATION OF THE DEVICE BY CONMED QUALITY ENGINEER WILL NOT BE ACCOMPLISHED. I AM IN COMMUNICATION WITH THE END-USER FACILITY ATTEMPTING TO OBTAIN FURTHER INFORMATION REGARDING THIS EVENT. IT WAS AGREED TO TAKE DIGITAL PICTURES OF THE DEVICE AND FORWARDED THEM TO CONMED; HOWEVER, THESE PHOTOGRAPHS HAVE NOT BEEN RECEIVED TO DATE. ON THE COMPLETION OF THE QUALITY ENGINEERING INVESTIGATION A SUPPLEMENTAL REPORT WILL BE FILED. DEVICE BEING HELD BY RISK MANAGEMENT.

    Additional Manufacturer Narrative · 1

    THE SUSPECT DEVICE IS BEING RETAINED BY THE RISK MANAGEMENT DEPARTMENT OF THE END-USER FACILITY; THEREFORE, EVALUATION OF THE DEVICE BY CONMED QUALITY ENGINEER WILL NOT BE ACCOMPLISHED. I AM IN COMMUNICATION WITH THE END-USER FACILITY ATTEMPTING TO OBTAIN FURTHER INFORMATION REGARDING THIS EVENT. IT WAS AGREED TO TAKE DIGITAL PICTURES OF THE DEVICE AND FORWARDED THEM TO CONMED; HOWEVER, THESE PHOTOGRAPHS HAVE NOT BEEN RECEIVED TO DATE. ON THE COMPLETION OF THE QUALITY ENGINEERING INVESTIGATION A SUPPLEMENTAL REPORT WILL BE FILED. DEVICE BEING HELD BY RISK MANAGEMENT.

    Description of Event or Problem · 1

    IT WAS REPORTED, "HOSPITAL EMS UNIT RESPONDED TO A 911 CALL FOR A PATIENT IN CARDIAC ARREST. EMS UTILIZED A PHILLIPS MRX DEFIBRILLATOR UNIT WITH CONMED PADPRO PADS AND ADAPTER. WHEN APPLYING THE PADS FOR THE MONITOR/DEFIBRILLATOR THE MACHINE WOULD NOT SENSE, THE PADS CONNECTION TO ALLOW DEFIBRILLATION OF A PATIENT WHO REMAINED IN VENTRICULAR FIBRILLATION. ANOTHER AMBULANCE WAS REQUESTED IMMEDIATELY TO REPLACE THE MONITOR/DEFIBRILLATOR WHILE TROUBLE-SHOOTING PROCESSES CONTINUED INCLUDING CHECKING CONNECTIONS AND CHANGING PADS. ADDITIONALLY, THE FIRE DEPARTMENT ON SCENE UTILIZED A PADPRO ADAPTER FOR THEIR AED AND IT TOO COULD NOT SENSE THE PADS. AFTER THE EVENT, HOSPITAL BIOMED SERVICES DETERMINED THAT THE ADAPTER HAD A BROKEN WIRE INSIDE THE INSULATION. ANECDOTALLY WE ARE TOLD THAT THE FIRE DEPARTMENT ALSO DETERMINED THAT THEIR PADPRO ADAPTER HAD A BENT BRONG WHICH CONTRIBUTED TO THE FAILURE OF THEIR UNIT. THE PATIENT'S GIRLFRIEND REPORTED AT THE SCENE THAT THE PATIENT HAD A "HEART BLOCKAGE IN A POSITION THAT COULD NOT BE REPAIRED". NO OTHER INFORMATION IS AVAILABLE. SHE ALSO INDICATED THAT THE PRIOR EVENING THE PATIENT "TOOK A SHOT FOR IMPOTENCE PRESCRIBED BY HIS UROLOGIST".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    204097 MFE, MULTIFUNCTION ELECTRODE, ADAPTER, PHILLIPS PLUG AED MFE ADAPTOR MKJ CONMED CORPORATION 0509271

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Death