BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOPULSE LI-ION BATTERY

    MDR report key: 2953868 · Received January 11, 2013

    Report

    Report Number
    3003793491-2013-00058
    Event Type
    Malfunction
    Date Received
    January 11, 2013
    Date of Event
    December 13, 2012
    Report Date
    December 13, 2012
    Manufacturer
    ZOLL CIRCULATION, INC.
    Product Code
    DRM
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ZOLL MEDICAL CORP 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 THE RED LED WAS ON AS THE BATTERY WAS TAKEN OUT OF THE BOX. NO ADVERSE EVENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    17512 AUTOPULSE LI-ION BATTERY LI-ION BATTERY DRM ZOLL CIRCULATION, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Other