BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TOTALCARE

    MDR report key: 2022405 · Received February 16, 2011

    Report

    Report Number
    1824206-2011-00888
    Event Type
    Malfunction
    Date Received
    February 16, 2011
    Date of Event
    November 19, 2010
    Report Date
    November 19, 2010
    Manufacturer
    HILL-ROM, INC.
    Product Code
    FNL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE ACCOUNT ORDERED A REPLACEMENT HYDRAULIC MANIFOLD. THE ACCOUNT HAS NOT RETURNED HILL-ROM'S ATTEMPTS TO DETERMINE THE RESOLUTION OF THE ALLEGED MALFUNCTION.

    Description of Event or Problem · 1

    THE ACCOUNT ALLEGED THE HEAD HI/LOW IS SLOWLY DRIFTING DOWN. IT IS A SLOW BUT NOTICEABLE DRIFT. THE ACCOUNT HAS REPLACED THE HEAD HI/LOW DOWN AND TREND VALUES AND THE ROD LOCK BUT THE ISSUE REMAINS.

    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