BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REMANUFACTURED BED

    MDR report key: 2140864 · Received May 31, 2011

    Report

    Report Number
    1824206-2011-02975
    Event Type
    Malfunction
    Date Received
    May 31, 2011
    Date of Event
    May 10, 2011
    Report Date
    May 10, 2011
    Manufacturer
    HILL-ROM, INC.
    Product Code
    FNL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE TECH FOUND THE CENTRAL BRAKE STEER ASSEMBLY WAS NOT ACTIVATING PROPERLY AND THE BRAKE/STEER CASTER WOULD NOT ADJUST. THE TECH REPLACED THE BRAKE/STEER CASTER AND ADJUSTED THE CASTERS TO REPAIR THE BED. CASTERS WERE WORN. THE RETRACTABLE BED SERVICE MANUAL STATES; HILL-ROM RECOMMENDS PERFORMING PREVENTIVE MAINTENANCE ANNUALLY. TEST THE BRAKES TO DETERMINE IF THE BED MOVES WHEN THE BRAKE IS ACTIVATED. ADJUST IF REQUIRED. INSPECT THE STEER ACTIVATION, AND ADJUST IF REQUIRED. CHECK THE CASTER TIRES FOR CUTS, WEAR, TREND ETC. REPLACE IF NECESSARY.

    Description of Event or Problem · 1

    THE ACCOUNT ALLEGED THE BRAKES ARE NOT HOLDING ON THE BED. THE BED HAS NOT BEEN SERVICED IN OVER THREE YRS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 REMANUFACTURED BED AC-POWERED ADJUSTABLE HOSPITAL BED FNL HILL-ROM, INC. 8400

    Patients

    Seq Age Sex Outcome Treatment
    1