BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EXCELCARE BARIATRIC BED FRAME

    MDR report key: 1850037 · Received September 28, 2010

    Report

    Report Number
    1045510-2010-00014
    Event Type
    Malfunction
    Date Received
    September 28, 2010
    Date of Event
    July 1, 2009
    Report Date
    July 1, 2009
    Manufacturer
    HILL-ROM, INC
    Product Code
    FNL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    DURING A FUNCTION CHECK, A HILL-ROM SERVICE TECHNICIAN FOUND THAT THE CPR CABLE NEEDED A TENSION ADJUSTMENT. THE CABLE'S TENSION WAS ADJUSTED AND THE CPR FUNCTION BEGAN TO WORK PROPERLY. PURSUANT TO OUR RESPONSE TO WARNING LETTER (B)(4), HILL-ROM IS CONTINUING 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