BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GYNNIE OB-GYN STRETCHER

    MDR report key: 3053026 · Received April 11, 2013

    Report

    Report Number
    0001831750-2013-03179
    Event Type
    Malfunction
    Date Received
    April 11, 2013
    Date of Event
    March 14, 2013
    Report Date
    March 14, 2013
    Manufacturer
    STRYKER MEDICAL-KALAMAZOO
    Product Code
    FPO
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    UPON COMPLETION OF THE MANUFACTURER'S INVESTIGATION, IT WAS DETERMINED THAT THE UNIT COULD NOT GO INTO BRAKE USING THE SIDE CONTROL PEDALS, BUT THE UNIT COULD STILL BE ENGAGED USING THE HEAD END BRAKE PEDAL. THEREFORE, THIS UNIT COULD STILL GO INTO BRAKE, IF NEEDED. ADDITIONALLY, STEER IS A CUSTOMER PREFERENCE AND THE UNIT COULD STILL BE MOBILE WITHOUT THE STEER FUNCTION.

    Description of Event or Problem · 1

    IT WAS REPORTED VIA REPAIR WORK ORDER THAT THE GEAR PIN AND FRAME WERE WORN CAUSING THE UNIT TO NOT GO INTO STEER FROM THE SIDE PEDALS. 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 GEAR PIN AND FRAME WERE WORN CAUSING THE UNIT TO NOT GO INTO STEER FROM THE SIDE PEDALS. 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
    155674 GYNNIE OB-GYN STRETCHER STRETCHER, WHEELED FPO STRYKER MEDICAL-KALAMAZOO

    Patients

    Seq Age Sex Outcome Treatment
    1