BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOPULSE BATTERY CHARGER

    MDR report key: 2902951 · Received November 29, 2012

    Report

    Report Number
    3003793491-2012-00420
    Event Type
    Malfunction
    Date Received
    November 29, 2012
    Date of Event
    October 31, 2012
    Report Date
    November 1, 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 F/U REPORT WHEN OUR INVESTIGATION IS COMPLETED.

    Description of Event or Problem · 1

    THE CUSTOMER COMPLAINT THAT THE DEVICE STOPPED COMPRESSION AFTER WORKING A FEW TIMES. THE CUSTOMER RE-INSERTED AND REPLACED THE BATTERY BUT IT DID NOT IMPROVE. AT A LATER DATE, THE DEVICE WORKED BY USING OTHER BATTERY. WHEN USING THE FAULTED BATTERY, THE PROBLEM OCCURRED AGAIN. THE CUSTOMER CONFIRMED EACH BATTERY HAD ADEQUATE POWER VIA BATTERY'S STATUS LAMP. THE CUSTOMER WOULD LIKE THE PLATFORM, THE BATTERIES, AND THE BATTERY CHARGER TO BE EVALUATED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Other