BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOPULSE® LI-ION BATTERY

    MDR report key: 3954056 · Received July 23, 2014

    Report

    Report Number
    3003793491-2014-00371
    Event Type
    Malfunction
    Date Received
    July 23, 2014
    Date of Event
    July 1, 2014
    Report Date
    July 1, 2014
    Manufacturer
    ZOLL CIRCULATION, INC
    Product Code
    DRM
    PMA / PMN Number
    K112998
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ZOLL HAS NOT YET RECEIVED THE AUTOPULSE BATTERY IN COMPLAINT FOR INVESTIGATION. A SUPPLEMENTAL REPORT WILL BE FILED IF AND WHEN THE PRODUCT IS RETURNED AND INVESTIGATION HAS BEEN COMPLETED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE AUTOPULSE LI-ION BATTERY SHOWS A FAULT IN THE CHARGER. HOWEVER, THE BATTERY WILL SHOW A COUPLE OF BARS BUT IS NOT DISABLED BY THE CHARGER. THIS IS SEEN IN BOTH CHARGER BAYS. NO PATIENT INVOLVEMENT WAS REPORTED. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    430500 AUTOPULSE® LI-ION BATTERY LI-ION BATTERY DRM ZOLL CIRCULATION, INC 8700-0752-01

    Patients

    Seq Age Sex Outcome Treatment
    1