BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOPULSE NIMH BATTERY

    MDR report key: 2935822 · Received January 2, 2013

    Report

    Report Number
    3003793491-2012-00685
    Event Type
    Malfunction
    Date Received
    January 2, 2013
    Date of Event
    September 26, 2012
    Report Date
    September 26, 2012
    Manufacturer
    ZOLL CIRCULATION, INC.
    Product Code
    DRM
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE AUTOPULSE NIMH BATTERY (SN (B)(4)) IS INVOLVED IN THE EVENT AND WAS RETURNED TO ZOLL MEDICAL CORPORATION ON (B)(4) 2012 AND WAS ANALYZED. VISUAL INSPECTION OF THE BATTERY SHOWED NO DAMAGES. REPORTED PROBLEM WAS CONFIRMED. THE BATTERY FAILED TESTING AND WILL BE SCRAPPED. NO ADVERSE EVENT WAS REPORTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT BATTERY FAILED TESTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1514 AUTOPULSE NIMH BATTERY NIMH BATTERY DRM ZOLL CIRCULATION, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Other