BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOPULSE NIMH BATTERY

    MDR report key: 2972093 · Received January 22, 2013

    Report

    Report Number
    3003793491-2012-00432
    Event Type
    Malfunction
    Date Received
    January 22, 2013
    Date of Event
    June 21, 2012
    Report Date
    July 5, 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

    REPORTED COMPLAINT OF DEFECTIVE BATTERY WAS NOT CONFIRMED BECAUSE THE BATTERY WAS NOT CONFIRMED BECAUSE THE BATTERY WAS NOT RETURNED AND TEST DATA WAS NOT PROVIDED. 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 INFLUENCE BY THE FREQUENCY OF USE AND FREQUENCY OF ROUTINE BATTERY MAINTENANCE. BASED ON ITS MFR DATE, THIS BATTERY IS MORE THAN 2 YEARS OLD AND HAS PASSED THE END OF ITS USEFUL LIFE. NO ADVERSE EVENT REPORTED.

    Description of Event or Problem · 1

    CUSTOMER COMPLAINED OF DEFECTIVE BATTERIES. FOR 4 BATTERIES, CUSTOMER REPORTED THAT THE SYS SUDDENLY STOPPED INDICATING THAT THE BATTERIES WERE EMPTY, BUT THE BATTERIES WERE FULLY CHARGED. CUSTOMER ALSO INDICATED THAT TEST DATA FOR THE BATTERIES WOULD BE SENT TO ZOLL CIRCULATION. NO ADVERSE EVENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    31923 AUTOPULSE NIMH BATTERY NIMH BATTERY DRM ZOLL CIRCULATION, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Other