BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TOTALCARE SPO2RT

    MDR report key: 1982368 · Received January 13, 2011

    Report

    Report Number
    1824206-2011-00175
    Event Type
    Malfunction
    Date Received
    January 13, 2011
    Date of Event
    December 14, 2010
    Report Date
    December 15, 2010
    Manufacturer
    HILL-ROM, INC.
    Product Code
    FNL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE TECHNICIAN REPLACED THE HEAD HI/LOW VALVE TO REPAIR THE BED.

    Description of Event or Problem · 1

    INFORMATION REC'D INDICATES THE BED LOST THE HEAD UP FUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TOTALCARE SPO2RT AC POWERED ADJUSTABLE HOSPITAL BED FNL HILL-ROM, INC. 1900

    Patients

    Seq Age Sex Outcome Treatment
    1