BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DRAGER EVITA XL VENTILATOR

    MDR report key: 1626023 · Received March 5, 2010

    Report

    Report Number
    1626023
    Event Type
    Injury
    Date Received
    March 5, 2010
    Date of Event
    February 19, 2010
    Report Date
    March 4, 2010
    Manufacturer
    DRAEGER MEDICAL INC.
    Product Code
    CBK
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    NC, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    RN HEARD LOUD BANGING NOISE COMING FROM THE PT'S ROOM. SHE ENTERED THE ROOM AND NOTICED SMOKE COMING FROM THE BACK OF THE VENTILATOR. THE VENTILATOR WAS DISCONNECTED AND REMOVED. THE PT WAS BAGGED ON 100% O2. REPLACEMENT VENTILATOR WAS RECONNECTED AND THE PT'S VITALS RETURNED TO BASELINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DRAGER EVITA XL VENTILATOR VENTILATOR CBK DRAEGER MEDICAL INC. EVITA XL

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Required Intervention