BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOPULUSE NIMH BATTERY

    MDR report key: 2924193 · Received December 14, 2012

    Report

    Report Number
    3003793491-2012-00374
    Event Type
    Malfunction
    Date Received
    December 14, 2012
    Date of Event
    April 17, 2012
    Report Date
    April 17, 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

    BATTERY SN (B)(4) WAS NOT RETURNED, BUT THE TEST DATA WAS PROVIDED. BATTERY MAINTENANCE PROGRAM LITERATURE INDICATES THAT THE USEFUL LIFE OF EACH AUTOPULSE BATTERY IS BETWEEN 2-4 YEARS. WITHIN 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 (12/2009), THIS BATTERY MAY HAVE AGED PAST THE END OF ITS USEFUL LIFE. HOWEVER, BATTERY DATA SHOWED A FULL CHARGE AFTER TEST CYCLE. THEREFORE, THE EXPERIENCED EVENT MAY BE ATTRIBUTED TO NOT PERFORMING DAILY SWAPS AND/OR NOT FULLY CHARGING THE BATTERY BEFORE DEPLOYMENT. NO ADVERSE EVENT REPORTED.

    Description of Event or Problem · 1

    FOR (B)(4), IT WAS REPORTED THAT 49 BATTERIES WERE NOT OPERATING CORRECTLY. FOR BATTERY SN (B)(4) REPORTED DESCRIPTION WAS THAT THE BATTERY DID NOT WORK EVEN THOUGH IT WAS FULLY CHARGED. NO ADVERSE EVENT REPORTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Other