BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TOTAL CARE

    MDR report key: 2052465 · Received March 16, 2011

    Report

    Report Number
    1824206-2011-01609
    Event Type
    Malfunction
    Date Received
    March 16, 2011
    Date of Event
    February 24, 2011
    Report Date
    February 24, 2011
    Manufacturer
    HILL-ROM INC.
    Product Code
    FNL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    TECHNICIAN STATED, HE COULD WATCH THE DRIFT HAPPEN. NO PT INVOLVED. NO PT IMPACT. CHECKED THE EMERGENCY CPR RELEASE CONNECTION. VERIFIED IT HAD PLAY BETWEEN THE PEDAL AND THE VALVE STEM AND COULD SEE IT ACTUATE WHEN CPR PEDAL WAS USED. NO OBVIOUS FLUID LEAKS. REPLACED THE HEAD UP VALVE ON THIS BED'S HYDRAULIC MANIFOLD TO RESOLVE THIS ISSUE. UNIT IS BACK IN SERVICE.

    Description of Event or Problem · 1

    COMPLAINT ALLEGED THAT THE HEAD SECTION WAS DRIFTING ON THE BED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TOTAL CARE AC POWERED ADJUSTABLE HOSPITAL BED FNL HILL-ROM INC. PR1900

    Patients

    Seq Age Sex Outcome Treatment
    1