BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REMANUFACTURED

    MDR report key: 1850394 · Received September 20, 2010

    Report

    Report Number
    1824206-2010-10033
    Event Type
    Malfunction
    Date Received
    September 20, 2010
    Date of Event
    August 25, 2010
    Report Date
    August 25, 2010
    Manufacturer
    HILL-ROM INC.
    Product Code
    FNL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    TECHNICIAN FOUND A WAX/DIRT BUILD UP ON THE CASTERS' WHEEL. TECHNICIAN WAS UNABLE TO CLEAN THE BUILD UP OFF OF THE CASTER WHEEL. TECHNICIAN ALSO FOUND SOME CRACKING ON THE RUBBER OF THE CASTER WHEEL. TECHNICIAN REPLACED THE BRAKE STEER CASTER AND BRAKE CASTERS TO RESOLVE THE ISSUE.

    Description of Event or Problem · 1

    TECHNICIAN ALLEGED THAT THE BED WAS SLIDING WHILE IN BRAKE MODE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 REMANUFACTURED A/C POWERED ADJUSTABLE HOSPITAL BED FNL HILL-ROM INC. P8400

    Patients

    Seq Age Sex Outcome Treatment
    1