BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GOBED II MED/SURG BED

    MDR report key: 3024008 · Received March 27, 2013

    Report

    Report Number
    0001831750-2013-02616
    Event Type
    Malfunction
    Date Received
    March 27, 2013
    Date of Event
    February 23, 2013
    Report Date
    February 25, 2013
    Manufacturer
    STRYKER MEDICAL-KALAMAZOO
    Product Code
    FNL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SUPPLEMENTAL SUBMITTED AS INVESTIGATION FOUND THE ISSUE WAS THAT THE FOWLER WOULD NOT RAISE. IT COULD BE LOWERED TO ITS LOW, FLAT HEIGHT, WHICH IS THE OPTIMAL POSITION FOR MEDICAL INTERVENTION. THE FOWLER WAS NOT DRIFTING. 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 FOWLER GAS CYLINDER WAS DAMAGED AND COULD NOT HOLD THE WEIGHT OF THE FOWLER. 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 FOWLER GAS CYLINDER WAS DAMAGED AND COULD NOT HOLD THE WEIGHT OF THE FOWLER. 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
    126772 GOBED II MED/SURG BED BED, AC-POWERED ADJUSTABLE HOSPITAL FNL STRYKER MEDICAL-KALAMAZOO

    Patients

    Seq Age Sex Outcome Treatment
    1