BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CCU BED W/SCALE

    MDR report key: 1993587 · Received January 24, 2011

    Report

    Report Number
    1824206-2011-00402
    Event Type
    Malfunction
    Date Received
    January 24, 2011
    Date of Event
    May 12, 2008
    Report Date
    May 12, 2008
    Manufacturer
    HILL-ROM INC.
    Product Code
    FNL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    TECHNICIAN REPLACED BOTH HEAD END BRAKE CASTERS, THE TUBE ASSEMBLY AND THE FOOT END PEDAL TO RESOLVE THE ISSUE. THIS MDR IS A RESULT OF CAPA ACTIVITY FOR THE RETROSPECTIVE REVIEW OF COMPLAINTS.

    Description of Event or Problem · 1

    THE ACCOUNT ALLEGED THAT THE BRAKE CASTERS DO NOT HOLD. NO PT IMPACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CCU BED W/SCALE A/C POWERED ADJUSTABLE HOSPITAL BED FNL HILL-ROM INC. 894

    Patients

    Seq Age Sex Outcome Treatment
    1