BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADVANTA ADVANTA FRAME

    MDR report key: 1777038 · Received May 19, 2010

    Report

    Report Number
    1824206-2010-07418
    Event Type
    Malfunction
    Date Received
    May 19, 2010
    Date of Event
    May 16, 2007
    Report Date
    May 16, 2007
    Manufacturer
    HILL-ROM, INC.
    Product Code
    FNL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    TECHNICIAN REPLACED THE SCALE POWER CONTROL BOARD TO RESOLVE THE ISSUE. PURSUANT TO OUR RESPONSE TO WARNING LETTER 2008-DT-04, HILL-ROM IS CONTINUING ITS RETROSPECTIVE REVIEW OF EVENTS FOR REPORTABILITY. THIS EFFORT WILL CONTINUE UNTIL WE ARE CURRENT.

    Description of Event or Problem · 1

    TECHNICIAN ALLEGED THAT THE BED EXIT HAD NO AUDIO ALARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ADVANTA ADVANTA FRAME AC POWERED ADJUSTABLE HOSPITAL BED FNL HILL-ROM, INC. P1604B005706

    Patients

    Seq Age Sex Outcome Treatment
    1