BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOPULSE NIMH BATTERY

    MDR report key: 2972064 · Received January 22, 2013

    Report

    Report Number
    3003793491-2012-00458
    Event Type
    Malfunction
    Date Received
    January 22, 2013
    Date of Event
    July 9, 2012
    Report Date
    July 9, 2012
    Manufacturer
    ZOLL CIRCULATION, INC.
    Product Code
    DRM
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINT OF "BATTERY WAS BELOW POWER CRITERIA" WAS NOT CONFIRMED BECAUSE THE BATTERY WAS NOT RETURNED FOR INVESTIGATION AND BATTERY MAINTENANCE RECORD WAS NOT PROVIDED. A SUPPLEMENTAL REPORT WILL BE FILED IF THE BATTERIES ARE RETURNED. NO ADVERSE EVENT REPORTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DESPITE FOLLOWING PROPER BATTERY MANAGEMENT, BATTERIES HAVE BEEN FOUND TO BE BELOW POWER CRITERIA. NO ADVERSE EVENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    31680 AUTOPULSE NIMH BATTERY NIMH BATTERY DRM ZOLL CIRCULATION, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Other