BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOPULSE NIMH BATTERY

    MDR report key: 2943138 · Received December 13, 2012

    Report

    Report Number
    3003793491-2012-00413
    Event Type
    Malfunction
    Date Received
    December 13, 2012
    Date of Event
    July 11, 2012
    Report Date
    July 12, 2012
    Manufacturer
    ZOLL CIRCULATION, INC.
    Product Code
    DRM
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE BATTERY WAS NOT RETURNED FOR INVESTIGATION. BASED ON THE TEST DATA THAT WAS PROVIDED, THE BATTERY WAS NOT TEST CYCLED ON A MONTHLY BASIS. FURTHERMORE, THIS BATTERY WAS MANUFACTURED IN JANUARY 2010 AND WAS OVER 2.5 YEARS OLD. 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 MANUFACTURE DATE, THIS BATTERY HAS AGED PAST THE END OF ITS USEFUL LIFE. LACK OF PROPER BATTERY MAINTENANCE MAY ALSO HAVE AFFECTED ITS LIFE.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THAT BATTERIES S/N (B)(4) OPERATED FOR 5 MINUTES EVEN THOUGH THEY WERE FULLY CHARGED. BATTERIES S/N (B)(4) REACHED THEIR END OF LIFE IN LESS THAN 2 YEARS OF SERVICE EVEN THOUGH PROPER BATTERY MAINTENANCE WAS PERFORMED. TEST DATA FOR THE BATTERIES WERE SENT. NO ADVERSE EVENT REPORTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Other