BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REMANUFACTURED BED

    MDR report key: 1945964 · Received December 28, 2010

    Report

    Report Number
    1824206-2010-11959
    Event Type
    Malfunction
    Date Received
    December 28, 2010
    Date of Event
    December 10, 2010
    Report Date
    December 10, 2010
    Manufacturer
    HILL-ROM, INC.
    Product Code
    FNL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE TECH FOUND THE BRAKE WAS NOT HOLDING DUE TO THE ACCOUNT INSTALLING THE WRONG AFTERMARKET BRAKE AND BRAKE/STEER CASTERS ON THE BED. THE TECH INSTALLED THE CORRECT CASTERS TO REPAIR THE BED.

    Description of Event or Problem · 1

    THE ACCOUNT ALLEGED THAT THE BED HAS A PROBLEM WITH THE BRAKES NOT HOLDING.

    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