BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EXCELCARE BARIATRIC BED FRAME

    MDR report key: 1850066 · Received September 28, 2010

    Report

    Report Number
    1045510-2010-00016
    Event Type
    Malfunction
    Date Received
    September 28, 2010
    Date of Event
    September 10, 2009
    Report Date
    September 10, 2009
    Manufacturer
    HILL-ROM, INC
    Product Code
    FNL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, 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 GO UP. A HILL-ROM SERVICE TECHNICIAN FOUND THAT THE CPR LEVER WAS STUCK. AN ADJUSTMENT WAS MADE TO THE CPR LEVER TO ALLOW THE CPR LEVER TO FUNCTION PROPERLY. PURSUANT TO OUR RESPONSE TO WARNING LETTER (B)(4), 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