BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STANDARD MODEL BED FL19F-1

    MDR report key: 3202039 · Received July 2, 2013

    Report

    Report Number
    0001831750-2013-05982
    Event Type
    Malfunction
    Date Received
    July 2, 2013
    Date of Event
    June 4, 2013
    Report Date
    June 4, 2013
    Manufacturer
    STRYKER MEDICAL-KALAMAZOO
    Product Code
    FMS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DE, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED VIA REPAIR WORK ORDER THAT THE INACCURATE SCALE READING WAS DUE TO A MALFUNCTIONED LOAD CELL. THERE WAS PATIENT INVOLVEMENT; HOWEVER, NO ADVERSE CONSEQUENCE OR CLINICALLY RELEVANT DELAY IN TREATMENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    302788 STANDARD MODEL BED FL19F-1 BED, PEDIATRIC OPEN HOSPITAL FMS STRYKER MEDICAL-KALAMAZOO

    Patients

    Seq Age Sex Outcome Treatment
    1