BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EXCELCARE BARIATRIC BED FRAME

    MDR report key: 1544951 · Received November 6, 2009

    Report

    Report Number
    1045510-2009-00024
    Event Type
    Malfunction
    Date Received
    November 6, 2009
    Date of Event
    October 10, 2009
    Report Date
    October 10, 2009
    Manufacturer
    GENDRON, INC.
    Product Code
    FNL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A HILL-ROM TECHNICIAN INSPECTED THE BED AND FOUND ALL SIDERAILS OPERATING PROPERLY. HILL-ROM ENGINEERING IS CURRENTLY INVESTIGATING THE ROOT CAUSE.

    Description of Event or Problem · 1

    IT WAS REPORTED TO HILL-ROM THAT THE SIDERAIL OF THE EXCEL CARE BED WAS NOT LOCKED, CAUSING IT TO SWIVEL DOWN. THE SIDERAIL WAS ALLEGEDLY IN THE "UP" POSITION, BUT NOT LOCKED. AS A PATIENT WAS ROLLING OVER IN BED, THE SIDERAIL ALLEGEDLY ARTICULATED DOWNWARD AND THE PATIENT FELL FROM THE BED. NO SERIOUS INJURIES OCCURRED. A HILL-ROM TECHNICIAN INSPECTED THE BED AND FOUND ALL SIDERAILS OPERATING PROPERLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EXCELCARE BARIATRIC BED FRAME AC-POWERED ADJUSTABLE HOSPITAL BED FNL GENDRON, INC. 90812

    Patients

    Seq Age Sex Outcome Treatment
    1