BEUDAMED
    FDA Adverse Event Other Summary report: N

    ESPIRIT

    MDR report key: 533863 · Received June 15, 2004

    Report

    Report Number
    533863
    Event Type
    Other
    Date Received
    June 15, 2004
    Date of Event
    May 17, 2004
    Report Date
    June 8, 2004
    Manufacturer
    RESPIRONICS CALIFORNIA, INC.
    Product Code
    CBK
    Report Source
    User Facility report
    Reporter Location
    CA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PT DESATURATED. RN (REGISTERED NURSE) SWITCHED THE PT TO FIO2 (FRACTIONAL INSPIRED OXYGEN) AT 100%. THEN RESTARTED THE VENTILATOR AND PLACED PT BACK ON. RN NOTED MESSAGE ON VENTILATOR: O2 VALVE STUCK, CLOSED. PT BAGGED AND THEN PLACED ON NEW VENTILATOR. BIOMEDICAL ENGINEERING COMPLETED TECHNICAL ASSESSMENT AND COULD NOT REPRODUCE PROBLEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ESPIRIT VENTILATOR CBK RESPIRONICS CALIFORNIA, INC. * *

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Other