BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DRAEGER EVITA XL INTENSIVE CARE VENT

    MDR report key: 1311398 · Received January 13, 2009

    Report

    Report Number
    1311398
    Event Type
    Malfunction
    Date Received
    January 13, 2009
    Date of Event
    November 29, 2008
    Report Date
    January 13, 2009
    Manufacturer
    DRAEGER INC
    Product Code
    CBK
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MI, US

    Narratives

    Description of Event or Problem · 1

    RN AT BEDSIDE CHANGING PATIENT. VENTILATOR (DRAEGER EVITA XL) ALARMED, READ "PEEP VALVE ERROR". CONTACTED DRAEGER FOR SERVICE. PATIENT WAS IMMEDIATELY REMOVED FROM THE VENT, BAGGED WITH AMBU BAG, AND THEN PLACED ON A DIFFERENT VENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DRAEGER EVITA XL INTENSIVE CARE VENT VENTILATOR CBK DRAEGER INC 8414900-26 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 17 MO