BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CCU BED

    MDR report key: 2063193 · Received March 16, 2011

    Report

    Report Number
    1824206-2011-01608
    Event Type
    Malfunction
    Date Received
    March 16, 2011
    Date of Event
    February 21, 2011
    Report Date
    February 21, 2011
    Manufacturer
    HILL-ROM, INC.
    Product Code
    FNL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WV, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE TECHNICIAN FOUND THE FOOT END PEDAL ASSEMBLY WAS DISCONNECTED FROM THE TORQUE TUBE ASSEMBLY. THE CLEVIS PIN BROKE WHICH ALLOWED THE PEDAL ASSEMBLY TO SLIDE OUT. THE TECHNICIAN INSTALLED THE PEDAL ASSEMBLY BACK IN THE LOWER FRAME AND CONNECTED IT TO THE TORQUE TUBE AND INSTALLED A NEW CLEVIS PIN AND COTTER PIN TO REPAIR THE BED.

    Description of Event or Problem · 1

    THE ACCOUNT ALLEGED THE BRAKE IS NOT HOLDING ON THE BED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CCU BED AC-POWERED ADJUSTABLE HOSPITAL BED FNL HILL-ROM, INC. 894

    Patients

    Seq Age Sex Outcome Treatment
    1