BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOPULSE NIMH BATTERY

    MDR report key: 2945313 · Received December 31, 2012

    Report

    Report Number
    3003793491-2012-00557
    Event Type
    Malfunction
    Date Received
    December 31, 2012
    Date of Event
    September 3, 2012
    Report Date
    September 4, 2012
    Manufacturer
    ZOLL CIRCULATION, INC.
    Product Code
    DRM
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    ZOLL CIRCULATION HAS NOT RECEIVED THE PRODUCT FOR EVAL AND THIS COMPLAINT IS STILL UNDER INVESTIGATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT BATTERY S/N (B)(4) SHOWN "FAIL" SIGN ON CHARGER BUT THE BATTERY INDICATOR ILLUMINATES GREEN LED. THE BATTERY OF LIFE ENDED WITHIN 2 YEARS UNDER APPROPRIATE MAINTENANCE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Other