BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TOTALCARE SPO2RT

    MDR report key: 2030650 · Received March 22, 2011

    Report

    Report Number
    1824206-2011-01765
    Event Type
    Malfunction
    Date Received
    March 22, 2011
    Date of Event
    February 25, 2011
    Report Date
    February 25, 2011
    Manufacturer
    HILL-ROM INC.
    Product Code
    FNL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE TECH REPLACED TWO STICKING SOLENOID VALVES ON THE HEAD UP AND THE HEAD HIGH VALVES TO REPAIR THE BED.

    Description of Event or Problem · 1

    INFO RECEIVED INDICATES THE HEAD SECTION IS STUCK IN THE DOWN POSITION. THE NURSE IS USING REVERSE TRENDELENBURG TO KEEP THE PT'S HEAD ELEVATED.

    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 UNK