BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TOTALCARE

    MDR report key: 1905694 · Received November 12, 2010

    Report

    Report Number
    1824206-2010-11002
    Event Type
    Malfunction
    Date Received
    November 12, 2010
    Date of Event
    October 19, 2010
    Report Date
    October 19, 2010
    Manufacturer
    HILL-ROM, INC.
    Product Code
    FNL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE ACCOUNT WAS GIVEN INFORMATION FOR A MATTRESS REVITALIZATION KIT.

    Description of Event or Problem · 1

    INFORMATION RECEIVED INDICATES A PATIENT PASSED AWAY ON THE BED AND WAS LEFT ON THE MATTRESS FOR A LONG PERIOD OF TIME CAUSING THE MATTRESS TO BECOME BLOOD SOAKED. THE BLOOD SOAKED THROUGH THE TICKING, INTO THE FIRE BARRIER AND THE FOAM TOPPER.

    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 UNK