BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GOBED II

    MDR report key: 3214062 · Received July 9, 2013

    Report

    Report Number
    0001831750-2013-06188
    Event Type
    Malfunction
    Date Received
    July 9, 2013
    Date of Event
    June 12, 2013
    Report Date
    June 12, 2013
    Manufacturer
    STRYKER MEDICAL-KALAMAZOO
    Product Code
    FNL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHEN THE BED WAS PLUGGED IN, IT LOCKED OUT THE OPTIONAL HAND PENDANT PORT RESULTING IN THE LOSS OF PENDANT FUNCTIONALITY. THE HOSPITAL DID NOT ORDER NURSE CALL FUNCTIONALITY ON THE SIDERAILS, THEREFORE WITH THE NON-FUNCTIONAL PENDANT, THE NURSE CALL FEATURE COULD NOT BE UTILIZED. THERE WAS NO DEVICE MALFUNCTION AND THE BED WAS MANUFACTURED TO SPECIFICATIONS; THE BED¿S DIP SWITCHES WERE NOT CONFIGURED TO THE HOSPITAL¿S NURSE CALL SYSTEM. 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
    313295 GOBED II BED, AC-POWERED ADJUSTABLE HOSPITAL FNL STRYKER MEDICAL-KALAMAZOO

    Patients

    Seq Age Sex Outcome Treatment
    1