BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GYNNIE OB-GYN STRETCHER

    MDR report key: 3060962 · Received April 16, 2013

    Report

    Report Number
    0001831750-2013-03323
    Event Type
    Malfunction
    Date Received
    April 16, 2013
    Date of Event
    March 19, 2013
    Report Date
    March 19, 2013
    Manufacturer
    STRYKER MEDICAL-KALAMAZOO
    Product Code
    FPO
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS ORIGINALLY REPORTED THAT THE BRAKES WOULD NOT ENGAGE/WOULD NOT HOLD DUE TO A BROKEN/DAMAGED GEAR PIN AND BASE FRAME WELDMENT. IT WAS FOUND THROUGH THE INVESTIGATION THAT THE SIDE CONTROL BRAKE/STEER WAS INOPERABLE DUE TO AN OBLONG HOLE IN THE WELDMENT. THIS ONLY AFFECTED THE SIDE CONTROLS OF THE UNIT. THE BRAKES AND STEER FEATURE COULD STILL BE APPLIED BY AN ALTERNATE PEDAL.

    Description of Event or Problem · 1

    IT WAS REPORTED VIA REPAIR WORK ORDER THAT THE BRAKES WOULD NOT ENGAGE/WON'T HOLD DUE TO BROKEN/DAMAGED GEAR PIN AND BASE FRAME WELDMENT. 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 WOULD NOT ENGAGE/WON'T HOLD DUE TO BROKEN/DAMAGED GEAR PIN AND BASE FRAME WELDMENT. 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
    163724 GYNNIE OB-GYN STRETCHER STRETCHER, WHEELED FPO STRYKER MEDICAL-KALAMAZOO

    Patients

    Seq Age Sex Outcome Treatment
    1