BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOPULSE NIMH BATTERY

    MDR report key: 2972139 · Received January 22, 2013

    Report

    Report Number
    3003793491-2012-00471
    Event Type
    Malfunction
    Date Received
    January 22, 2013
    Date of Event
    July 17, 2012
    Report Date
    July 27, 2012
    Manufacturer
    ZOLL CIRCULATION, INC.
    Product Code
    DRM
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    REPORTED COMPLAINT OF BATTERY FAILED "OUTPUT TESTING WITH A BATTERY TESTER" COULD NOT BE VERIFIED BECAUSE THE BATTERY WAS NOT RETURNED FOR INVESTIGATION. BATTERY MAINTENANCE PROGRAM LITERATURE INDICATES THAT THE USEFUL LIFE OF EACH AUTOPULSE BATTERY IS BETWEEN 2 - 4 YEARS. THE LIFE OF EACH BATTERY IS INFLUENCED BY THE FREQUENCY OF USE, AND THE FREQUENCY OF ROUTINE BATTERY MAINTENANCE. BASED ON ITS SERIAL NUMBER, THIS BATTERY WAS MANUFACTURED PRIOR TO 2010. GIVEN THAT THE COMPLAINT WAS REPORTED IN (B)(4) 2012, THIS BATTERY WAS GREATER THAN 2 YEARS OLD AND MAY HAVE AGED PAST THE END OF IT USEFUL LIFE. NO ADVERSE EVENT REPORTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT 16 BATTERIES FAILED OUTPUT TESTING WITH A BATTERY TESTER. NO ADVERSE EVENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    31933 AUTOPULSE NIMH BATTERY NIMH BATTERY DRM ZOLL CIRCULATION, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Other