BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOPULSE NIMH BATTERY

    MDR report key: 2924083 · Received December 14, 2012

    Report

    Report Number
    3003793491-2012-00445
    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

    Narratives

    Additional Manufacturer Narrative · 1

    BATTERY SN (B)(4) WAS NOT RETURNED, BUT THE TEST DATA WAS PROVIDED. POWER OUTPUT OF THIS BATTERY WAS BELOW SPECIFICATIONS. BASED ON THE TEST DATA, THIS BATTERY WAS NOT TEST CYCLED ON A MONTHLY BASIS; PRODUCT LABELING INDICATES THAT THE BATTERY IS TO BE TEST CYCLED AT LEAST ONCE EVERY MONTH. FURTHERMORE, THIS BATTERY IS OVER TWO YEARS OLD. BATTERY MAINTENANCE PROGRAM LITERATURE INDICATES THAT THE USEFUL LIFE OF EACH AUTOPULSE BATTERY IS BETWEEN 2-4 YEARS. WITHIN THE 2-4 YEARS TIME PERIOD, THE LIFE OF EACH BATTERY IS INFLUENCED BY THE FREQUENCY OF USE AND THE FREQUENCY OF ROUTINE BATTERY MAINTENANCE. THEREFORE, BATTERY FAILURE IS LIKELY DUE TO IMPROPER MAINTENANCE AND/OR OLD AGE. 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 AUTOPULSE NIMH BATTERY NIMH BATTERY DRM ZOLL CIRCULATION, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Other