BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TOTALCARE

    MDR report key: 1991364 · Received January 27, 2011

    Report

    Report Number
    1824206-2011-00517
    Event Type
    Malfunction
    Date Received
    January 27, 2011
    Date of Event
    January 5, 2011
    Report Date
    January 5, 2011
    Manufacturer
    HILL-ROM INC.
    Product Code
    FNL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WV, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE ACCOUNT'S MAINTENANCE STATED, ALL THE COILS ARE ENERGIZING AND THE HYDRAULIC FLUID LEVEL IS GOOD AND THE FOOT IN/OUT AND FOOT UP DOWN WORKS, BUT NOTHING ELSE. HE TOOK HEAD UP VALVE PLUNGER OFF TO INSPECT AND HE SAID, IT SEEMED TO HAVE VACUUM PRESSURE ON IT. HE REINSTALLED THE VALVE WITHOUT THE PLUNGER AND THE ISSUE RETURNED. HE REMOVED THE VALVE TO PUT THE PLUNGER BACK IN AND THE VALVE HAD FLUID PRESSURE ON IT. THE ACCOUNT'S MAINTENANCE STATED, HE REMOVED, CLEANED AND REINSTALLED THE VALVES TO REPAIR THE BED.

    Description of Event or Problem · 1

    THE ACCOUNT'S MAINTENANCE ALLEGED, THE HYDRAULIC MOTOR WILL RUN FROM THE SIDERAIL SWITCH OR CALIBRATION SCREEN, BUT THE FOOT ARTICULATION IS THE ONLY FUNCTION THAT OPERATES. THERE IS NO MANUAL FUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TOTALCARE AC-POWERED ADJUSTABLE HOSPITAL BED FNL HILL-ROM INC. 1900

    Patients

    Seq Age Sex Outcome Treatment
    1