BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOPULSE NIMH BATTERY

    MDR report key: 2972101 · Received January 22, 2013

    Report

    Report Number
    3003793491-2012-00453
    Event Type
    Malfunction
    Date Received
    January 22, 2013
    Date of Event
    July 9, 2012
    Report Date
    July 9, 2012
    Manufacturer
    ZOLL CIRCULATION, INC.
    Product Code
    DRM
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    MANUFACTURE DATE OF THIS BATTERY, WHICH IS ESTIMATED TO BE DECEMBER 2009, WAS PROVIDED. GIVEN THAT THE COMPLAINT WAS REPORTED IN (B)(4) 2012, THIS BATTERY WAS OVER 2.5 YEARS OLD AT THE TIME THIS REPORT WAS FILED. 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 MFG DATE, THIS BATTERY (SERIAL# (B)(4)) HAS AGED PAST THE END OF ITS USEFUL LIFE. NO ADVERSE EVENT REPORTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DESPITE FOLLOWING PROPER BATTERY MGMT, BATTERIES HAVE BEEN FOUND TO BE BELOW POWER CRITERIA. NO ADVERSE EVENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    32053 AUTOPULSE NIMH BATTERY NIMH BATTERY DRM ZOLL CIRCULATION, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Other