BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOPULSE NIMH BATTERY

    MDR report key: 2982441 · Received January 25, 2013

    Report

    Report Number
    3003793491-2013-00194
    Event Type
    Malfunction
    Date Received
    January 25, 2013
    Date of Event
    August 2, 2012
    Report Date
    August 9, 2012
    Manufacturer
    ZOLL CIRCULATION, INC
    Product Code
    DRM
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ZOLL MEDICAL CORPORATION HAS NOT RECEIVED THE PRODUCTS FOR EVALUATION. IF THE PRODUCTS ARE RETURNED TO THE MFR, SUPPLEMENTAL REPORTS WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT 32 AUTOPULSE NIMH BATTERIES FAILED OUTPUT TESTING WITH A BATTERY TESTER. THERE WAS NO REPORT OF PT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    36487 AUTOPULSE NIMH BATTERY AUTOPULSE NIMH BATTERY DRM ZOLL CIRCULATION, INC

    Patients

    Seq Age Sex Outcome Treatment
    1 Other