BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MA204

    MDR report key: 1873929 · Received September 29, 2010

    Report

    Report Number
    9680128-2010-00125
    Event Type
    Malfunction
    Date Received
    September 29, 2010
    Date of Event
    September 3, 2010
    Report Date
    September 3, 2010
    Manufacturer
    STRYKER MEDICAL QUEBEC LP
    Product Code
    FNL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ID, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    RESULT: WELD.

    Description of Event or Problem · 1

    IT IS REPORTED THAT THE ARM HAS A DISCONNECTED WELD. IT'S NOT PENETRATING INTO THE BAR. IT'S CAUSING THE RAIL TO TILT EXCESSIVELY WHEN LOWERED AND IS COMPROMISING PT SAFETY. NO INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MA204 HOSPITAL BED, A-C POWERED, ADJUSTABLE FNL STRYKER MEDICAL QUEBEC LP FL25E NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK