BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GOBED+

    MDR report key: 3170772 · Received June 14, 2013

    Report

    Report Number
    0001831750-2013-05442
    Event Type
    Malfunction
    Date Received
    June 14, 2013
    Date of Event
    May 20, 2013
    Report Date
    May 20, 2013
    Manufacturer
    STRYKER MEDICAL-KALAMAZOO
    Product Code
    FNL
    Removal / Correction Number
    RA-2011-070
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS ORIGINALLY REPORTED THAT THE SCALE BOARD MALFUNCTIONED. IT WAS DETERMINED UPON INVESTIGATION THAT THE SCALE BOARD DID NOT MALFUNCTION AND THE SCALE BEING INACCURATE WAS DUE TO LOAD CELL FAILURE.

    Description of Event or Problem · 1

    IT WAS REPORTED BY REPAIR WORK ORDER THAT THE SCALE WAS INACCURATE DUE TO MALFUNCTIONING LOAD CELLS. IT WAS ALSO REPORTED THAT THE SCALE BOARD MALFUNCTIONED. NO PATIENT WAS AFFECTED AND NO ADVERSE CONSEQUENCE OR CLINICALLY RELEVANT DELAY IN TREATMENT WAS REPORTED. IT WAS ORIGINALLY REPORTED THAT THE SCALE BOARD MALFUNCTIONED. IT WAS DETERMINED UPON INVESTIGATION THAT THE SCALE BOARD DID NOT MALFUNCTION AND THE SCALE BEING INACCURATE WAS DUE TO LOAD CELL FAILURE.

    Description of Event or Problem · 1

    IT WAS REPORTED BY REPAIR WORK ORDER THAT THE SCALE WAS INACCURATE DUE TO MALFUNCTIONING LOAD CELLS. IT WAS ALSO REPORTED THAT THE SCALE BOARD MALFUNCTIONED. 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
    271370 GOBED+ BED, AC-POWERED ADJUSTABLE HOSPITAL FNL STRYKER MEDICAL-KALAMAZOO

    Patients

    Seq Age Sex Outcome Treatment
    1