BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADVANCE

    MDR report key: 3893540 · Received February 14, 2014

    Report

    Report Number
    1824206-2014-00438
    Event Type
    Malfunction
    Date Received
    February 14, 2014
    Date of Event
    January 16, 2014
    Report Date
    January 16, 2014
    Manufacturer
    HILL-ROM, INC.
    Product Code
    FNL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    HILL-ROM SERVICE TECHNICIAN INSPECTED THE BED AND FOUND THAT BOTH BRAKE AND STEER CASTERS WERE NOT WORKING PROPERLY. HE REPLACED THE BRAKE AND STEER CASTERS AND THE BED FUNCTIONED AS EXPECTED. A SEARCH OF THE HILL-ROM MAINTENANCE RECORDS SHOWS THAT THE LAST PREVENTIVE MAINTENANCE PERFORMED BY HILL-ROM WAS JANUARY 2012. IT IS UNKNOWN IF THE FACILITY PERFORMS PREVENTATIVE MAINTENANCE ON THEIR BEDS.

    Description of Event or Problem · 1

    HILL-ROM RECEIVED A REPORT FROM A USER FACILITY STATING, "BRAKES NOT WORKING PROPERLY, BED STILL ROLLS WHEN BRAKE IS SET. THERE WAS NO PATIENT/INJURY REPORTED. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    99297 ADVANCE A/C POWERED ADJUSTABLE HOSPITAL BED FNL HILL-ROM, INC. P1165

    Patients

    Seq Age Sex Outcome Treatment
    1