BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GYNNIE OB-GYN STRETCHER

    MDR report key: 3063057 · Received April 17, 2013

    Report

    Report Number
    0001831750-2013-03388
    Event Type
    Malfunction
    Date Received
    April 17, 2013
    Date of Event
    March 20, 2013
    Report Date
    March 20, 2013
    Manufacturer
    STRYKER MEDICAL-KALAMAZOO
    Product Code
    FPO
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS ORIGINALLY REPORTED THAT THE BRAKE AND STEER COULD NOT BE ENGAGED. THE BRAKE AND STEER FUNCTION COULD NOT BE ENGAGED FROM THE SIDE CONTROL PEDAL. HOWEVER THE BRAKE AND STEER FUNCTION COULD STILL BE ENGAGED AT THE HEAD AND FOOT END OF THE STRETCHER.

    Description of Event or Problem · 1

    IT WAS ORIGINALLY REPORTED THAT THE BRAKE AND STEER COULD NOT BE ENGAGED. THE BRAKE AND STEER FUNCTION COULD NOT BE ENGAGED FROM THE SIDE CONTROL PEDAL. HOWEVER THE BRAKE AND STEER FUNCTION COULD STILL BE ENGAGED AT THE HEAD AND FOOT END OF THE STRETCHER. 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 AND STEER WILL NOT ENGAGE. 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
    164221 GYNNIE OB-GYN STRETCHER STRETCHER, WHEELED FPO STRYKER MEDICAL-KALAMAZOO

    Patients

    Seq Age Sex Outcome Treatment
    1