BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TOTALCARE - FOAM SURFACE, TOTAL CARE FRAME

    MDR report key: 1780354 · Received May 7, 2010

    Report

    Report Number
    1824206-2010-40936
    Event Type
    Malfunction
    Date Received
    May 7, 2010
    Date of Event
    May 1, 2008
    Report Date
    May 1, 2008
    Manufacturer
    HILL-ROM INC.
    Product Code
    FNL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ACCOUNT ADJUSTED THE CPR LINKAGE 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

    ACCOUNT ALLEGED THAT THEY CHANGED THE MANIFOLD AND NOW THE HEAD OF THE BED WILL NOT RAISE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TOTALCARE - FOAM SURFACE, TOTAL CARE FRAME A/C POWERED ADJUSTABLE HOSPITAL BED FNL HILL-ROM INC. P1900

    Patients

    Seq Age Sex Outcome Treatment
    1