BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POSITION PRO

    MDR report key: 1190212 · Received October 6, 2008

    Report

    Report Number
    MW5008553
    Event Type
    Malfunction
    Date Received
    October 6, 2008
    Date of Event
    September 20, 2008
    Report Date
    October 6, 2008
    Manufacturer
    STRYKER MEDICAL
    Product Code
    FNM
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    KY, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    DISCOVERED SEVERELY BURNED POWER PLUG AND BURNED OUTLET COVER AND OUTLET RECEPTACLE WHERE AIR MATTRESS WAS PLUGGED IN. PROBLEM WAS IDENTIFIED WHEN PT'S BED WAS MOVED FOR PT CARE. UNSURE WHEN IT OCCURRED. THE LINE CONDUCTOR PRONG WAS BURNED OFF AND WELDED INTO THE RECEPTACLE. THE GROUNDING PIN AND NEUTRAL PRONG WAS NOT ON THE PLUG NOR IN THE RECEPTACLE. NO ONE KNOWS EXPLANATION FOR MISSING CONDUCTORS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 POSITION PRO AIR MATTRESS, POSITIONING FNM STRYKER MEDICAL 2920-000-000

    Patients

    Seq Age Sex Outcome Treatment
    1