BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOPULSE NIMH BATTERY

    MDR report key: 2981329 · Received January 25, 2013

    Report

    Report Number
    3003793491-2012-00298
    Event Type
    Malfunction
    Date Received
    January 25, 2013
    Date of Event
    April 6, 2012
    Report Date
    April 24, 2012
    Manufacturer
    ZOLL CIRCULATION, INC.
    Product Code
    DRM
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SI
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE BATTERY INVOLVED IN THE REPORTED EVENT FAILED TESTING IN THE CHARGER, AND POWER LEVELS COULD NOT BE RECORDED. THIS BATTERY WAS MANUFACTURED IN 2008. BATTERY MAINTENANCE PROGRAM LITERATURE INDICATES THAT THE USEFUL LIFE OF EACH AUTOPULSE BATTERY IS BETWEEN 2-4 YEARS. WITHIN THE 2-4 YEAR TIME PERIOD, THE LIFE OF EACH BATTERY IS INFLUENCED BY THE FREQUENCY OF USE AND THE FREQUENCY OF ROUTINE BATTERY MAINTENANCE. BASED ON THE MANUFACTURED DATE, THIS BATTERY HAS AGED PAST THE END OF ITS USEFUL LIFE. NO ADVERSE EVENT REPORTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE AUTOPULSE SYSTEM GENERATED USER ADVISORY 2 AND USER ADVISORY 45 ERRORS AND STOPPED COMPRESSION. NO ADVERSE EVENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    36532 AUTOPULSE NIMH BATTERY NIMH BATTERY DRM ZOLL CIRCULATION, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Other