BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SM204 M-SERIES W/BIG WHEEL

    MDR report key: 3031443 · Received April 2, 2013

    Report

    Report Number
    0001831750-2013-02820
    Event Type
    Malfunction
    Date Received
    April 2, 2013
    Date of Event
    March 7, 2013
    Report Date
    March 7, 2013
    Manufacturer
    STRYKER MEDICAL-KALAMAZOO
    Product Code
    FPO
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    UPON COMPLETION OF THE MANUFACTURER'S INVESTIGATION IT WAS FOUND THAT THE PATIENT RIGHT LATCH ASSEMBLY WAS BROKEN, CAUSING THE TOPRAIL TO BE DIFFICULT TO LOCK AND UNLOCK. HOWEVER, THE SIDE RAIL WAS STILL ABLE TO REMAIN LATCHED IN THE UPRIGHT POSITION AND TO BE UNLATCHED IF NEEDED.

    Description of Event or Problem · 1

    IT WAS REPORTED VIA REPAIR WORK ORDER THAT THE SIDERAIL COULD NOT REMAIN LATCHED DUE TO A BROKEN LATCH ASSEMBLY. NO PATIENT WAS AFFECTED AND NO ADVERSE CONSEQUENCE OR CLINICALLY RELEVANT DELAY IN TREATMENT WAS REPORTED.

    Description of Event or Problem · 1

    IT WAS REPORTED VIA REPAIR WORK ORDER THAT THE SIDERAIL COULD NOT REMAIN LATCHED DUE TO A BROKEN LATCH ASSEMBLY. NO PATIENT WAS AFFECTED AND NO ADVERSE CONSEQUENCE OR CLINICALLY RELEVANT DELAY IN TREATMENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    133898 SM204 M-SERIES W/BIG WHEEL STRETCHER, WHEELED FPO STRYKER MEDICAL-KALAMAZOO

    Patients

    Seq Age Sex Outcome Treatment
    1