BEUDAMED
    FDA Adverse Event Death Summary report: N

    EVITA

    MDR report key: 525850 · Received May 18, 2004

    Report

    Report Number
    2517967-2004-00077
    Event Type
    Death
    Date Received
    May 18, 2004
    Date of Event
    April 17, 2004
    Report Date
    April 21, 2004
    Manufacturer
    DRAEGER MEDICAL, INC.
    Product Code
    CBK
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT: WHILE THE DEVICE WAS VENTILATING A PT, THE PT SELF EXTUBATED AND THEN EXPIRED. IT WAS REPORTED THAT THERE WAS NO IMMEDIATE RESPONSE BY HOSPITAL PERSONNEL TO THE ALARMS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EVITA CONTINUOUS VENTILATOR CBK DRAEGER MEDICAL, INC. 2 DURA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Death