BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOPULSE NIMH BATTERY

    MDR report key: 2902001 · Received November 8, 2012

    Report

    Report Number
    3003793491-2012-00170
    Event Type
    Malfunction
    Date Received
    November 8, 2012
    Date of Event
    June 22, 2012
    Report Date
    June 22, 2012
    Manufacturer
    ZOLL CIRCULATION, INC.
    Product Code
    DRM
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ZOLL MEDICAL CORP HAS NOT RECEIVED THE PRODUCT FOR EVALUATION AND THIS COMPLAINT IS STILL UNDER INVESTIGATION. IF PRODUCT IS RETURNED TO THE MANUFACTURER, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN AUTOPULSE NIMH BATTERY WITH S/N (B)(4) LED WAS NOT ILLUMINATING. ALSO THE BATTERY CHARGER RED LED ILLUMINATED WHEN THE BATTERY WAS INSERTED INTO THE BAY. THERE WAS NO REPORT OF A PT INJURY.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Other