BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EXECEL CARE BARIATRIC BED FRAME

    MDR report key: 2974679 · Received January 18, 2013

    Report

    Report Number
    1045510-2013-00001
    Event Type
    Malfunction
    Date Received
    January 18, 2013
    Date of Event
    October 25, 2012
    Report Date
    October 25, 2012
    Manufacturer
    HILL-ROM, INC.
    Product Code
    FNL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    REFERENCE FOR CODE DESCRIPTION.

    Description of Event or Problem · 1

    HILL-ROM ADDRESSED A COMPLAINT ON ONE OF ITS EXCELCARE BARIATRIC BED FRAMES ALLEGING THE CPR ASSEMBLY WAS NOT WORKING. A HILL-ROM SERVICE TECHNICIAN PERFORMED AN INVESTIGATION AT THE SERVICE CENTER AND FOUND THE CPR HANDLE MISSING FROM THE ASSEMBLY. THE TECHNICIAN ORDERED A NEW HANDLE AND INSTALLED IT TO RETURN FUNCTION TO THE CPR ASSEMBLY. THIS REPAIR WAS FOUND AFTER A RETROSPECTIVE REVIEW OF OPEN WAREHOUSE REPAIRS AND WAS PROCESSED AS SOON AS IT WAS REVIEWED AND DETERMINED TO BE A REPORTABLE MALFUNCTION. HILL-ROM IS REPORTING THIS MALFUNCTION IN COMPLIANCE WITH 21CFR803.3 WHERE THIS FAILURE MODE WAS INVOLVED IN AN ADVERSE EVENT ON (B)(6) 2009, INDICATED IN MDR1045510-2009-00021.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    28662 EXECEL CARE BARIATRIC BED FRAME AC POWERED ADJUSTABLE HOSPITAL BED FNL HILL-ROM, INC. 90812

    Patients

    Seq Age Sex Outcome Treatment
    1