BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TOTALCARE

    MDR report key: 2191749 · Received July 28, 2011

    Report

    Report Number
    1824206-2011-03992
    Event Type
    Malfunction
    Date Received
    July 28, 2011
    Date of Event
    May 26, 2011
    Report Date
    May 26, 2011
    Manufacturer
    HILL-ROM, INC.
    Product Code
    FNL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE TECHNICIAN FOUND THE SEAL FOR THE MANUAL CPR VALVE WAS DETERIORATED, DEFORMED AND STUCK IN THE PILOT VALVE INSIDE THE MANIFOLD. THE TECHNICIAN REMOVED THE REMAINING PIECES OF THE SEAL AND REPLACED THE CPR VALVE TO REPAIR THE BED.

    Description of Event or Problem · 1

    INFORMATION RECEIVED INDICATES THE HEAD SECTION WILL NOT GO DOWN USING MANUAL CPR.

    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