BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STRYKER EPIC II

    MDR report key: 1183343 · Received October 1, 2008

    Report

    Report Number
    1183343
    Event Type
    Malfunction
    Date Received
    October 1, 2008
    Date of Event
    September 28, 2008
    Report Date
    October 1, 2008
    Manufacturer
    STRYKER MEDICAL
    Product Code
    FNL
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    TX, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    WHILE ATTEMPTING TO RAISE THE HEAD OF THE BED, THE AREA OF THE BED WHERE THE ELECTRICAL CORD ENTERS INTO THE BED BEGAN SPARKING AND SMOKING. PATIENT WAS IN THE BED, BUT NO HARM WAS INCURRED. BED WAS IMMEDIATELY UNPLUGGED AND PATIENT WAS TRANSFERRED TO ANOTHER BED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STRYKER EPIC II BED, ELECTRIC FNL STRYKER MEDICAL 2030 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 18 YR