BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SM104 M-SERIES W/5TH WHEEL

    MDR report key: 1940261 · Received December 9, 2010

    Report

    Report Number
    1831750-2010-04638
    Event Type
    Malfunction
    Date Received
    December 9, 2010
    Date of Event
    November 11, 2010
    Report Date
    November 11, 2010
    Manufacturer
    STRYKER CORP., MEDICAL DIV.
    Product Code
    FPO
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT HAS BEEN REPORTED THAT THE BUSHINGS IN THE RAIL ARE SPLITTING CAUSING THE RAIL TO DROP AND NOT LOCK IN PLACE. NO PT INVOLVEMENT OR ADVERSE CONSEQUENCES ARE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SM104 M-SERIES W/5TH WHEEL HOSPITAL WHEELED STRETCHER FPO STRYKER CORP., MEDICAL DIV. 1007 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK