BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TOTALCARE SPO2RT

    MDR report key: 1821016 · Received August 27, 2010

    Report

    Report Number
    1824206-2010-09616
    Event Type
    Malfunction
    Date Received
    August 27, 2010
    Date of Event
    August 4, 2010
    Report Date
    August 4, 2010
    Manufacturer
    HILL-ROM, INC.
    Product Code
    FNL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE BED WAS REPLACED AT THE FACILITY. REPAIRS HAVE NOT BEEN COMPLETED.

    Description of Event or Problem · 1

    INFORMATION RECEIVED INDICATES THE HEAD FUNCTION BUTTONS DO NOT WORK.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1