BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOPULSE NIMH BATTERY

    MDR report key: 2901877 · Received November 20, 2012

    Report

    Report Number
    3003793491-2012-00285
    Event Type
    Malfunction
    Date Received
    November 20, 2012
    Date of Event
    August 24, 2012
    Report Date
    August 30, 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 RECEIVED THE PRODUCT AND WILL BE PROVIDING A FOLLOW-UP REPORT WHEN OUR INVESTIGATION IS COMPLETED.

    Description of Event or Problem · 1

    DURING A ROUTINE SHIFT CHECK BY (B)(6) HOSPITAL, THE BATTERY WAS FOUND TO BE FAULTY. BATTERY S/N (B)(4) COULD NOT BE CHARGED. WHEN PUSHING THE STATUS CHECK BUTTON, THE LED COULD NOT ILLUMINATE. THE BATTERY COULD NOT ESTABLISH COMMUNICATION WITH THE BATTERY TESTER. THE FAIL LED ON THE BATTERY CHARGER ILLUMINATE SOON AFTER INSERTING THE BATTERY IN THE BATTERY BAY.

    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