BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOPULSE NIMH BATTERY

    MDR report key: 2934700 · Received December 21, 2012

    Report

    Report Number
    3003793491-2012-00590
    Event Type
    Malfunction
    Date Received
    December 21, 2012
    Date of Event
    November 29, 2012
    Report Date
    November 29, 2012
    Manufacturer
    ZOLL CIRCULATION, INC.
    Product Code
    DRM
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ZOLL MEDICAL CORPORATION HAS RECEIVED THE DEVICE ASSOCIATED WITH THIS REPORT. HOWEVER, THE DEVICE IS STILL UNDER INVESTIGATION. . A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE INVESTIGATION IS COMPLETED.

    Description of Event or Problem · 1

    DURING USE, AUTOPULSE OPERATED FOR ABOUT 4 MINUTES AND THEN INDICATED CHANGE THE BATTERY. ON THE SCREEN, THE BATTERY INDICATED THAT IT WAS FULL. THE BATTERY WAS CHANGED AND THE AUTOPULSE RESTARTED. IT OPERATED FOR ABOUT 2 MINUTES AND THEN SHOWED CHANGE BATTERY. THE SECOND BATTERY ALSO INDICATED IT WAS FULL ON THE SCREEN. CUSTOMER INDICATED THAT THEY FOLLOWED THE BATTERY MAINTENANCE PROGRAM REQUIREMENTS. NO ADVERSE EVENT REPORTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Other