BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOPULSE NIMH BATTERY

    MDR report key: 2960826 · Received January 11, 2013

    Report

    Report Number
    3003793491-2013-00050
    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
    PMA / PMN Number
    K112998
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    OUTCOMES ATTRIBUTED TO ADVERSE EVENT SHOULD NOT HAVE BEEN CHECKED ON THE INITIAL REPORT SINCE NO ADVERSE EVENTS WERE REPORTED.

    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 THE BATTERY WAS DISABLED BY THE CHARGER. NO ADVERSE EVENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    19538 AUTOPULSE NIMH BATTERY NIMH BATTERY DRM ZOLL CIRCULATION, INC. 8700-0702

    Patients

    Seq Age Sex Outcome Treatment
    1 Other