BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOPULSE® LI-ION BATTERY

    MDR report key: 4221117 · Received November 3, 2014

    Report

    Report Number
    3010617000-2014-00585
    Event Type
    Malfunction
    Date Received
    November 3, 2014
    Date of Event
    October 9, 2014
    Report Date
    October 9, 2014
    Manufacturer
    ZOLL CIRCULATION
    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 RECEIVED THE PRODUCT IN COMPLAINT. A SUPPLEMENTAL REPORT WILL BE FILED IF AND WHEN THE PRODUCT IS RETURNED AND INVESTIGATION HAS BEEN PERFORMED.

    Description of Event or Problem · 1

    COMPLAINANT ALLEGED THAT AN AUTOPULSE® LI-ION BATTERY WILL NOT HOLD A CHARGE AND THE RED LED ON THE BATTERY IS ILLUMINATED. NO ADVERSE PATIENT SEQUELAE WAS REPORTED. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    702963 AUTOPULSE® LI-ION BATTERY LI-ION BATTERY DRM ZOLL CIRCULATION 8700-0752-01

    Patients

    Seq Age Sex Outcome Treatment
    1