BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SM204 M-SERIES W/BIG WHEEL

    MDR report key: 3090422 · Received May 2, 2013

    Report

    Report Number
    0001831750-2013-04056
    Event Type
    Malfunction
    Date Received
    May 2, 2013
    Date of Event
    April 5, 2013
    Report Date
    April 5, 2013
    Manufacturer
    STRYKER MEDICAL-KALAMAZOO
    Product Code
    FPO
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS ALSO FOUND DURING THE INVESTIGATION THAT THE SIDE RAIL COULD NOT BE LATCHED UP DUE TO DAMAGED COMPONENTS.

    Description of Event or Problem · 1

    IT WAS REPORTED VIA REPAIR WORK ORDER THAT THE BRAKES COULD NOT FULLY ENGAGE DUE TO WORN BRAKE RINGS, 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 BRAKES COULD NOT FULLY ENGAGE DUE TO WORN BRAKE RINGS AND THE SIDE RAIL COULD NOT BE LATCHED UP DUE TO DAMAGED COMPONENTS. 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
    192435 SM204 M-SERIES W/BIG WHEEL STRETCHER, WHEELED FPO STRYKER MEDICAL-KALAMAZOO

    Patients

    Seq Age Sex Outcome Treatment
    1