BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SM204 M-SERIES 2/BIG WHEEL

    MDR report key: 2243293 · Received September 2, 2011

    Report

    Report Number
    1831750-2011-09419
    Event Type
    Malfunction
    Date Received
    September 2, 2011
    Date of Event
    August 8, 2011
    Report Date
    August 8, 2011
    Manufacturer
    STRYKER MEDICAL
    Product Code
    FPO
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    LOCKING SPINDLE.

    Description of Event or Problem · 1

    IT WAS REPORTED BY SERVICE REPORT THAT THE TOP RAIL AND LOCKING SPINDLE WERE BROKEN CAUSING THE SIDERAIL TO NOT LOCK IN THE UPRIGHT POSITION. NO PT INVOLVEMENT OR ADVERSE CONSEQUENCES ARE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SM204 M-SERIES 2/BIG WHEEL HOSPITAL WHEELED STRETCHER FPO STRYKER MEDICAL 1015 NA

    Patients

    Seq Age Sex Outcome Treatment
    1