BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOPULSE LI-ION BATTERY

    MDR report key: 2920207 · Received December 17, 2012

    Report

    Report Number
    3003793491-2012-00520
    Event Type
    Malfunction
    Date Received
    December 17, 2012
    Date of Event
    November 9, 2012
    Report Date
    November 9, 2012
    Manufacturer
    ZOLL CIRCULATION, INC.
    Product Code
    DRM
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ZOLL MEDICAL CORPORATION HAS NOT YET RECEIVED THE DEVICE. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE DEVICE IS RECEIVED AND EVALUATED. NO ADVERSE EVENT REPORTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE INCOMING INSPECTION, BATTERY'S RED LED LIGHT WAS FLASHING. WHEN INSTALLED INTO THE MCC CHARGER, IT FAULTED RIGHT AWAY. NO ADVERSE EVENT REPORTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Other