BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GOBED II

    MDR report key: 3230131 · Received July 16, 2013

    Report

    Report Number
    0001831750-2013-06404
    Event Type
    Malfunction
    Date Received
    July 16, 2013
    Date of Event
    June 22, 2013
    Report Date
    June 22, 2013
    Manufacturer
    STRYKER MEDICAL-KALAMAZOO
    Product Code
    FNL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SUPPLEMENTAL SUBMITTED AS THE INVESTIGATION CONCLUDED THAT THE BED WAS DIFFICULT TO PUSH DUE TO HEAD LEFT CASTER WHEEL WAS DELAMINATING. THIS WOULD RESULT IN CAREGIVER ANNOYANCE AS BED WAS DIFFICULT TO PUSH DUE TO HEAD LEFT CASTER WHEEL WAS DELAMINATING, HOWEVER, IT IS NOT LIKELY TO HARM THE PATIENT AS IT WOULD STILL BE POSSIBLE TO MOVE THE BED TO TRANSPORT PATIENTS. 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 WHEEL WAS BROKEN DUE TO HEAD LEFT CASTER DELAMINATING WHICH CAUSED THE BED TO BE DIFFICULT TO PUSH. IT WAS ALSO REPORTED THAT THE POWER CORD GROUND PIN WAS MISSING. 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 POWER CORD GROUND PIN WAS MISSING. 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
    328806 GOBED II BED, AC-POWERED ADJUSTABLE HOSPITAL FNL STRYKER MEDICAL-KALAMAZOO

    Patients

    Seq Age Sex Outcome Treatment
    1