BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GOBED II

    MDR report key: 3222254 · Received July 12, 2013

    Report

    Report Number
    0001831750-2013-06269
    Event Type
    Malfunction
    Date Received
    July 12, 2013
    Date of Event
    June 12, 2013
    Report Date
    June 14, 2013
    Manufacturer
    STRYKER MEDICAL-KALAMAZOO
    Product Code
    FNL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SUPPLEMENTAL REPORT SUBMITTED AS INVESTIGATION FOUND THAT THE FOOTEND LIFT WAS STUCK AT ITS LOW HEIGHT. THE ISSUE OF THE FOOTEND LIFT BEING STUCK AT LOW HEIGHT IS AN ANNOYANCE ISSUE ONLY, AS LOW HEIGHT IS THE OPTIMAL POSITION FOR EMERGENCY MEDICAL INTERVENTION IF IT WERE TO BECOME REQUIRED. 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 WERE TO RECUR.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE LIFT MOTOR WAS NOT FUNCTIONAL DUE TO NYLON LIFT MOTOR NUTS MALFUNCTION. 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 THAT THE LIFT MOTOR WAS NOT FUNCTIONAL DUE TO NYLON LIFT MOTOR NUTS MALFUNCTION. 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
    322426 GOBED II BED, AC-POWERED ADJUSTABLE HOSPITAL FNL STRYKER MEDICAL-KALAMAZOO

    Patients

    Seq Age Sex Outcome Treatment
    1