BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EXCELCARE BARIATRIC BED FRAME

    MDR report key: 1850072 · Received September 28, 2010

    Report

    Report Number
    1045510-2010-00020
    Event Type
    Malfunction
    Date Received
    September 28, 2010
    Date of Event
    August 5, 2010
    Report Date
    August 5, 2010
    Manufacturer
    HILL-ROM, INC
    Product Code
    FNL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED TO HILL-ROM THAT THE HEAD SECTION OF THE BED WAS DRIFTING DOWN. THE HILL-ROM SERVICE TECH INSPECTED THE BED AND DETERMINED THAT THE CPR LEVER WAS STUCK OPEN. THE TECH ADJUSTED THE CPR CABLE WHICH CEASED DRIFTING AND RETURNED FUNCTION TO THE HEAD SECTION OF THE BED. 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 NA

    Patients

    Seq Age Sex Outcome Treatment
    1