BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOPULSE NIMH BATTERY

    MDR report key: 2981284 · Received January 25, 2013

    Report

    Report Number
    3003793491-2012-00345
    Event Type
    Malfunction
    Date Received
    January 25, 2013
    Date of Event
    June 6, 2012
    Report Date
    June 13, 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 WAS NOT RETURNED FOR INVESTIGATION; HOWEVER, TEST DATA FROM THE BATTERY WAS PROVIDED. BASED ON THIS DATA, THE BATTERY PASSED THE POWER TESTING (POWER RATING WAS ABOVE 1300W). SINCE THE BATTERY PASSED THE POWER TEST, THE LIKELY CAUSE FOR THE REPORTED EVENT IS THAT THE BATTERY WAS NOT FULLY CHARGED PRIOR TO USE IN THE DEVICE. NO ADVERSE EVENT REPORTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE STOPPED WITH A "REPLACE BATTERY" SCREEN, EVEN THOUGH A FULLY CHARGED BATTERY WAS BEING USED. TEST DATA FOR THE BATTERY WAS SENT. NO ADVERSE EVENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    35474 AUTOPULSE NIMH BATTERY NIMH BATTERY DRM ZOLL CIRCULATION, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Other