BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOPULSE LI-ION BATTERY

    MDR report key: 2881046 · Received November 9, 2012

    Report

    Report Number
    3003793491-2012-00224
    Event Type
    Malfunction
    Date Received
    November 9, 2012
    Date of Event
    September 24, 2012
    Report Date
    October 10, 2012
    Manufacturer
    ZOLL CIRCULATION, INC.
    Product Code
    MOQ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ZOLL MEDICAL CORP HAS RECEIVED THE PRODUCT AND WILL BE PROVIDING A SUPPLEMENTAL REPORT WHEN OUR INVESTIGATION IS COMPLETED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN AUTOPULSE LI-ION BATTERY, WHEN TESTED IN CHARGER WAS FAULTY. CUSTOMER ATTEMPTED TO TEST THE BATTERY AGAIN WITH A DIFFERENT CHARGER AND RECEIVED THE SAME RESULTS. THERE WAS NO REPORT OF A PT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AUTOPULSE LI-ION BATTERY AUTOPULSE LI-ION BATTERY MOQ ZOLL CIRCULATION, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Other