BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOPULSE NIMH BATTERY

    MDR report key: 2972107 · Received January 22, 2013

    Report

    Report Number
    3003793491-2012-00481
    Event Type
    Malfunction
    Date Received
    January 22, 2013
    Date of Event
    July 17, 2012
    Report Date
    July 27, 2012
    Manufacturer
    ZOLL CIRCULATION
    Product Code
    DRM
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    REPORTED COMPLAINT OF BATTERY "FAILED OUTPUT TESTING WITH A BATTERY TESTER" COULD NOT BE VERIFIED BECAUSE THE BATTERY WAS NOT RETURNED FOR INVESTIGATION. A SUPPLEMENTAL REPORT WILL BE FILED IF THE BATTERY IS RETURNED. NO ADVERSE EVENT REPORTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT 16 BATTERIES FAILED OUTPUT TESTING WITH A BATTERY TESTER. NO ADVERSE EVENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    32055 AUTOPULSE NIMH BATTERY NIMH BATTERY DRM ZOLL CIRCULATION

    Patients

    Seq Age Sex Outcome Treatment
    1 Other