BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOPULSE NIMH BATTERY

    MDR report key: 2931437 · Received January 4, 2013

    Report

    Report Number
    3003793491-2013-00018
    Event Type
    Malfunction
    Date Received
    January 4, 2013
    Date of Event
    July 6, 2012
    Report Date
    July 6, 2012
    Manufacturer
    ZOLL CIRCULATION, INC.
    Product Code
    DRM
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ZOLL MEDICAL CORPORATION HAS NOT YET RECEIVED BATTERY SN (B)(4). A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE BATTERY IS RECEIVED AND EVALUATED. NO ADVERSE EVENT REPORTED.

    Description of Event or Problem · 1

    CUSTOMER REPORTED TO BE EXPERIENCING LOW RUNTIMES WITH BATTERY SN (B)(4) EVEN THOUGH BATTERY WAS ROTATED AND MAINTAINED PROPERLY. NO ADVERSE EVENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    5446 AUTOPULSE NIMH BATTERY NIMH BATTERY DRM ZOLL CIRCULATION, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Other