BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GOBED II

    MDR report key: 3041484 · Received April 8, 2013

    Report

    Report Number
    0001831750-2013-03009
    Event Type
    Malfunction
    Date Received
    April 8, 2013
    Date of Event
    March 14, 2013
    Report Date
    March 14, 2013
    Manufacturer
    STRYKER MEDICAL-KALAMAZOO
    Product Code
    FNL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SUPPLEMENTAL SUBMITTED AS FURTHER INVESTIGATION DETERMINED THE SCALE WAS PERFORMING TO SPECIFICATION AND THERE WAS NO ALLEGED MALFUNCTION. THEREFORE, THIS ISSUE IS NOT LIKELY TO CAUSE OR CONTRIBUTE TO SERIOUS INJURY OR DEATH.

    Description of Event or Problem · 1

    IT WAS REPORTED VIA REPAIR WORK ORDER THAT THE SCALE WAS INACCURATE DUE TO LOAD CELL FAILURE. NO PATIENT WAS AFFECTED AND NO ADVERSE CONSEQUENCE OR CLINICALLY RELEVANT DELAY IN TREATMENT WAS REPORTED.

    Description of Event or Problem · 1

    IT WAS INITIALLY REPORTED THAT THE SCALE WAS INACCURATE DUE TO LOAD CELL FAILURE, HOWEVER, INVESTIGATION DETERMINED THERE WAS NO ALLEGED MALFUNCTION AND THE UNIT WAS PERFORMING TO SPECIFICATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    143885 GOBED II BED, AC-POWERED ADJUSTABLE HOSPITAL FNL STRYKER MEDICAL-KALAMAZOO

    Patients

    Seq Age Sex Outcome Treatment
    1