BEUDAMED
    FDA Adverse Event Death Summary report: N

    EVITA

    MDR report key: 445410 · Received February 28, 2003

    Report

    Report Number
    2517967-2003-00020
    Event Type
    Death
    Date Received
    February 28, 2003
    Date of Event
    January 24, 2003
    Report Date
    February 28, 2003
    Manufacturer
    DRAEGER MEDICAL, INC.
    Product Code
    BSZ
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT: THE PT DISCONNECTED THEMSELVES FROM THE VENTILATOR. THE PT WAS FOUND DECEASED WITH THE BREATHING CIRCUIT IN THEIR HAND. IT WAS REPORTED THAT AUDIBLE ALARMS AND VISUAL MESSAGES WERE ACTIVATED BY THE VENTILATOR AT THE TIME OF THE REPORTED OCCURRENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EVITA CONTINUOUS VENTILATOR BSZ DRAEGER MEDICAL, INC. 4 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Death