BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EXCELCARE BARIATRIC BED FRAME

    MDR report key: 1850069 · Received September 28, 2010

    Report

    Report Number
    1045510-2010-00013
    Event Type
    Malfunction
    Date Received
    September 28, 2010
    Date of Event
    June 4, 2009
    Report Date
    June 4, 2009
    Manufacturer
    HILL-ROM, INC
    Product Code
    FNL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED TO HILL-ROM THAT THE HEAD OF THE BED WOULD NOT STAY UP. A HILL-ROM SERVICE TECHNICIAN FOUND THAT A MIS-ROUTED HOSE WAS CAUSING THE CPR LEVER TO ACTIVATE. ONCE THE HOSE WAS RE-ROUTED CORRECTLY, THE CPR LEVEL FUNCTIONED PROPERLY. 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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EXCELCARE BARIATRIC BED FRAME AC-POWERED ADJUSTABLE HOSPITAL BED FNL HILL-ROM, INC P610B

    Patients

    Seq Age Sex Outcome Treatment
    1