BEUDAMED
    FDA Adverse Event Death Summary report: N

    PAD PRO PMS, DC, TRANSLUCENT

    MDR report key: 8444948 · Received March 22, 2019

    Report

    Report Number
    1320894-2019-00081
    Event Type
    Death
    Date Received
    March 22, 2019
    Report Date
    May 24, 2019
    Manufacturer
    CONMED CORPORATION
    Product Code
    MKJ
    PMA / PMN Number
    K020203
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: SEX: PREVIOUSLY BLANK NOW STATES FEMALE. OPERATOR OF DEVICE: PREVIOUSLY BLANK NO STATES HEALTH PROFESSIONAL. DEVICE EVALUATED BY MFR: PREVIOUSLY STATED TO BE RETURNED; NO STATES DISCARDED BY FACILITY. THE PATIENT DATE OF EXPIRATION WAS NEVER VERIFIED BY THE FACILITY. THE "CODE" TEAM TRIED 2 PACKAGES OF PAD PRO DEFIBRILATION PADS THEY WOULD NOT SHOW A TRACE. A THIRD ATTEMPT WAS MADE WITH ECG LEADS AND A DIFFERENT DEFIBRILATOR, THERE WAS A DELAY IN TRACING WITH THE EXTERNAL ECG PADS. THE PATIENT WAS THEN TRANSFERRED TO THE OPERATING ROOM, THEY OPENED THE CHEST AND USED INTERNAL PADDLES. THE PATIENT PASSED AWAY DUE TO DELAY IN THERAPY. THE DEVICE WAS DISCARDED BY THE FACILITY AND WAS NOT RETURNED TO CONMED FOR EVALUATION. ALTHOUGH REQUESTED, NO PHOTOGRAPHIC EVIDENCE HAS BEEN PROVIDED; THEREFORE, THE REPORTED FAILURE COULD NOT BE VERIFIED. A COMPLAINT LOT HISTORY AS WELL AS A DHR WERE NOT ABLE TO BE REVIEWED DUE TO THE UNAVAILABILITY OF THE LOT NUMBER. A TWO-YEAR REVIEW OF COMPLAINT HISTORY REVEALED THERE HAS BEEN 16 COMPLAINTS REGARDING 85 DEVICES FOR THIS DEVICE FAMILY AND FAILURE MODE. DURING THE SAME TIME FRAME 1,898,150 DEVICES HAVE BEEN MANUFACTURED AND SHIPPED WORLDWIDE. SHOULD ALL THE COMPLAINT DEVICES HAVE BEEN FOUND CONFIRMED, THE RATE OF FAILURE WOULD BE .00004. PER THE INSTRUCTIONS FOR USE, THE USER IS ADVISED THE FOLLOWING; MISUSE OF MULTIFUNCTION ELECTRODES, USE OF COMPROMISED OR ALTERED PRODUCT, AND/OR FAILURE TO FOLLOW PRODUCT INSTRUCTIONS MAY RESULT IN PATIENT BURNS, INADEQUATE DELIVERY OF THERAPY AND /OR LOSS OF ECG TRACE QUALITY. DO NOT FOLD, TRIM, CRUSH, OR STORE UNDER HEAVY OBJECTS. FOR UNIVERSAL FUNCTION ELECTRODE USE (I.E. MONITORING, DEFIBRILLATION AND PACING), THESE ELECTRODES MUST BE USED IN CONJUNCTION WITH AED AND ECG AMPLIFIERS THAT HAVE BEEN DESIGNED SPECIFICALLY TO COMPENSATE FOR LARGE DC OFFSETS. DO NOT EXCEED A SETTING OF 360 JOULES WHILE DEFIBRILLATING PATIENTS. ELECTRODES MUST BE USED BEFORE DATE INDICATED ON PACKAGE. DO NOT USE IF PACKAGING APPEARS COMPROMISED. A DETERMINIATION FOR FURTHER INVESTIGATION HAS BEEN INITIATED. THIS ISSUE WILL CONTINUE TO BE MONITORED THROUGH THE COMPLAINT SYSTEM TO ASSURE PATIENT SAFETY.

    Additional Manufacturer Narrative · 1

    AT THE TIME OF FILING, THE DATE OF INCIDENT IS REPORTED AS LATE (B)(6) 2019 THE REPORTED DEVICE IS BEING RETURNED TO CONMED FOR EVALUATION. A SUPPLEMENTAL AND FINAL REPORT WILL BE FILED FOLLOWING THE COMPLETION OF THE DEVICE EVALUATION AND COMPLAINT INVESTIGATION. THIS ISSUE WILL CONTINUE TO BE MONITORED THROUGH THE COMPLAINT SYSTEM TO ASSURE PATIENT SAFETY.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE 2516P, PAD PRO DEFIBRILLATION PADS, DID NOT WORK, THEY TRIED ANOTHER SET OF THE SAME PADS, THOSE ALSO DID NOT WORK. THE PATIENT EXPIRED. ADDITIONAL INFORMATION IS ANTICIPATED, AND CLARIFICATION OF INCIDENT DATE AND DATE OF DEATH ARE EXPECTED. THIS REPORT IS BEING RAISED DUE TO PATIENT DEATH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    235865 PAD PRO PMS, DC, TRANSLUCENT DEFIBRILLATION PADS MKJ CONMED CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 Death