BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADVANCE 2000

    MDR report key: 1811354 · Received August 17, 2010

    Report

    Report Number
    1824206-2010-09385
    Event Type
    Malfunction
    Date Received
    August 17, 2010
    Date of Event
    November 30, 2007
    Report Date
    November 30, 2007
    Manufacturer
    HILL-ROM, INC.
    Product Code
    FNL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    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

    THE TECHNICIAN ALLEGED THERE IS NO AUDIBLE SOUND WHEN BED EXIT IS ACTIVATED. HE REPLACED THE BED EXIT P.C. BOARD TO RESOLVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ADVANCE 2000 AC POWERED ADJUSTABLE HOSPITAL BED FNL HILL-ROM, INC. P1105F75

    Patients

    Seq Age Sex Outcome Treatment
    1