BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GOBED II

    MDR report key: 3052503 · Received April 11, 2013

    Report

    Report Number
    0001831750-2013-03167
    Event Type
    Malfunction
    Date Received
    April 11, 2013
    Date of Event
    March 20, 2013
    Report Date
    March 20, 2013
    Manufacturer
    STRYKER MEDICAL-KALAMAZOO
    Product Code
    FNL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOW-UP SUBMITTED WITH EVALUATION RESULTS.

    Description of Event or Problem · 1

    IT WAS REPORTED BY STRYKER SALES REP THAT THE HEAD END WAS DRIFTING DUE TO A FAULTY MOTOR AND NUT. 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 BY STRYKER SALES REP THAT THE HEAD END WAS DRIFTING DUE TO A FAULTY MOTOR AND NUT. 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
    156839 GOBED II BED, AC-POWERED ADJUSTABLE HOSPITAL FNL STRYKER MEDICAL-KALAMAZOO

    Patients

    Seq Age Sex Outcome Treatment
    1