BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EXCELCARE BARIATRIC BED FRAME

    MDR report key: 2860746 · Received October 30, 2012

    Report

    Report Number
    1045510-2012-00032
    Event Type
    Malfunction
    Date Received
    October 30, 2012
    Date of Event
    October 23, 2012
    Report Date
    October 23, 2012
    Manufacturer
    HILL-ROM, INC.
    Product Code
    FNL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, 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 CPR ASSEMBLY WAS WORKING INTERMITTENTLY. A HILL-ROM SERVICE TECHNICIAN PERFORMED AN INVESTIGATION AND FOUND THE CPR HANDLE BROKEN DURING HIS INSPECTION. HE REPLACED THE HANDLE, TIGHTENED THE 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)(4) 2009 INDICATED IN MDR 1045510-2009-0021.

    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