BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TOTALCARE

    MDR report key: 2091385 · Received May 5, 2011

    Report

    Report Number
    1824206-2011-02578
    Event Type
    Malfunction
    Date Received
    May 5, 2011
    Date of Event
    April 13, 2011
    Report Date
    April 13, 2011
    Manufacturer
    HILL-ROM INC.
    Product Code
    FNL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    TECHNICAL SUPPORT INSTRUCTED THE ACCOUNT TO INSPECT THE CPR HANDLE TO SEE IF IT WAS STICKING, REPLACE THE HEAD DOWN AND CPR VALVE IS NECESSARY. THE ACCOUNT HAS NOT RETURNED HILL-ROM'S ATTEMPTS TO DETERMINE THE RESOLUTION OF THE ALLEGED MALFUNCTION.

    Description of Event or Problem · 1

    INFORMATION RECEIVED INDICATES THE HEAD SECTION WAS DRIFTING ON THIS BED.

    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