BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DRAGER EVITA 2 DURA

    MDR report key: 280906 · Received June 1, 2000

    Report

    Report Number
    MW1019068
    Event Type
    Injury
    Date Received
    June 1, 2000
    Date of Event
    June 1, 2000
    Report Date
    June 1, 2000
    Manufacturer
    DRAGER, INC.
    Product Code
    CBK
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    RESPIRATORY THERAPIST

    Narratives

    Description of Event or Problem · 1

    THE PROBLEM OCCURS DURING MECHANICAL VENTILATION ON THE DRAGER E2 VENTILATOR WITH THE AUTOFLOW FEATURE TURNED ON AND THE O2 ENRICHMENT FUNCTION ACTIVE. FOLLOWING A DISCONNECTION AND RECONNECTION OF THE PT TO THE VENTILATOR A DELAY OF 45 TO 55 SECONDS HAS BEEN OBSERVED BEFORE TIDAL VOLUME DELIVERED AND MINUTE VENTILATION REACHES THE PRESET LEVEL. THIS CAUSES A PROLONGED AND PRECIPITOUS DROP IN VENTILATION AND MEAN AIRWAY PRESSURE AND HAS RESULTED IN FALLS IN PT OXYGEN SATURATION TO AS LOW AS 70% TO 80% WITH BRADYCARDIA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DRAGER EVITA 2 DURA MECHANICAL VENTILATOR CBK DRAGER, INC. EVITA 2 DURA *

    Patients

    Seq Age Sex Outcome Treatment
    1 * Life Threatening| O