BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GOBED II

    MDR report key: 2955683 · Received February 11, 2013

    Report

    Report Number
    0001831750-2013-00986
    Event Type
    Malfunction
    Date Received
    February 11, 2013
    Date of Event
    January 17, 2013
    Report Date
    January 17, 2013
    Manufacturer
    STRYKER MEDICAL-KALAMAZOO
    Product Code
    FNL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    FOLLOW-UP SUBMITTED AS FURTHER INVESTIGATION DETERMINED THE DAMAGED CASTER DID NOT AFFECT BRAKE FUNCTION AND IS, THEREFORE, NOT LIKELY TO HARM THE PATIENT AS THE BED COULD STILL BE MOVED. 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 WAS TO RECUR.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE BRAKES WERE NOT HOLDING, THE SCALE WAS NOT ACCURATE, AND THE BED WAS DRIFTING.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SCALE WAS NOT ACCURATE, AND THE BED WAS DRIFTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    58705 GOBED II BED, AC-POWERED ADJUSTABLE HOSPITAL FNL STRYKER MEDICAL-KALAMAZOO

    Patients

    Seq Age Sex Outcome Treatment
    1