BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EXCELCARE BARIATRIC BED FRAME

    MDR report key: 3042828 · Received December 14, 2012

    Report

    Report Number
    1045510-2012-00042
    Event Type
    Malfunction
    Date Received
    December 14, 2012
    Date of Event
    November 20, 2012
    Report Date
    November 20, 2012
    Manufacturer
    HILL-ROM INC.
    Product Code
    FNL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    HILL-ROM RECEIVED A COMPLAINT ON ONE OF ITS EXCELCARE BARIATRIC BED FRAMES ALLEGING THE HEAD SECTION OF THE BED WOULD NOT STAY IN AN ELEVATED POSITION. A HILL-ROM SERVICE TECH PERFORMED AN INVESTIGATION AND FOUND THE CPR CABLE ASSEMBLY WAS INOPERATIVE AND CAUSING THE HEAD TO LOWER. HE REPLACED THE CPR CABLE AND ADJUSTED IT TO RETURN FUNCTION TO THE CPR ASSEMBLY. HILL-ROM IS REPORTING THIS MALFUNCTION IN COMPLIANCE WITH 21CFR803.3 WHERE THIS FAILURE MODE WAS INVOLVED IN AN ADVERSE EVENT ON (B)(6) 2009 INDICATED IN MDR1045510-2009-00021.

    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. 90812

    Patients

    Seq Age Sex Outcome Treatment
    1