BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TOTALCARE BARIATRIC

    MDR report key: 2002042 · Received February 4, 2011

    Report

    Report Number
    1824206-2011-00665
    Event Type
    Malfunction
    Date Received
    February 4, 2011
    Date of Event
    January 12, 2011
    Report Date
    January 12, 2011
    Manufacturer
    HILL-ROM INC
    Product Code
    FNL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE ACCOUNT STATED THAT THE HEAD CYLINDER LOOKED BENT TO HIM AND THE SENSOR LINKAGE WAS BROKEN. REPAIRS HAVE NOT BEEN COMPLETED.

    Description of Event or Problem · 1

    THE ACCOUNT ALLEGED THE HEAD FRAME IS POPPED OUT OF THE SEAT SECTION TRACKS. HE SAID THE HEAD SECTION IS UP NOW AND WILL NOT LOWER DOWN ELECTRICALLY. HE TRIED LOWERING THE HEAD SECTION USING THE CPR AND THE HEAD SECTION LOWERED ABOUT 6 INCHES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TOTALCARE BARIATRIC AC-POWERED ADJUSTABLE HOSPITAL BED FNL HILL-ROM INC 1840

    Patients

    Seq Age Sex Outcome Treatment
    1