BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RENAISSANCE 29 STRETCHER 8/00

    MDR report key: 3220825 · Received July 11, 2013

    Report

    Report Number
    0001831750-2013-06257
    Event Type
    Malfunction
    Date Received
    July 11, 2013
    Date of Event
    January 1, 2013
    Report Date
    June 12, 2013
    Manufacturer
    STRYKER MEDICAL-KALAMAZOO
    Product Code
    FPO
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PREVIOUSLY, IT WAS REPORTED THAT THE BRAKES COULD NOT BE ENGAGED. UPON COMPLETION OF THE MANUFACTURER'S INVESTIGATION IT WAS DETERMINED THAT THE HEAD END BRAKE PEDAL COULD NOT ENGAGE THE BRAKES. HOWEVER, THE BRAKES WOULD HAVE BEEN ABLE TO BE ENGAGED USING AN ALTERNATIVE PEDAL IF NEEDED. SO THE UNIT COULD STILL BE PUT INTO BRAKE. NO PATIENT WAS AFFECTED AND NO ADVERSE CONSEQUENCE OR CLINICALLY RELEVANT DELAY IN TREATMENT WAS REPORTED. THIS ISSUE IS NOT LIKELY TO CAUSE OR CONTRIBUTE TO SERIOUS INJURY OR DEATH IF IT WAS TO RECUR.

    Description of Event or Problem · 1

    IT WAS REPORTED VIA REPAIR WORK ORDER THAT THE BRAKES COULD NOT BE ENGAGED DUE TO MALFUNCTIONED BRAKE ROD. 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 BE ENGAGED DUE TO MALFUNCTIONED BRAKE ROD. 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
    319864 RENAISSANCE 29 STRETCHER 8/00 STRETCHER, WHEELED FPO STRYKER MEDICAL-KALAMAZOO

    Patients

    Seq Age Sex Outcome Treatment
    1