BEUDAMED
    FDA Adverse Event Death Summary report: N

    EVITA

    MDR report key: 555903 · Received November 18, 2004

    Report

    Report Number
    2517967-2004-00163
    Event Type
    Death
    Date Received
    November 18, 2004
    Date of Event
    October 14, 2004
    Report Date
    October 14, 2004
    Manufacturer
    DRAEGER MEDICAL, INC.
    Product Code
    CBK
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT: WHILE THE DEVICE WAS VENTILATING A PATIENT; THE PATIENT SELF EXTUBATED THEM SELF. NO ONE WAS PRESENT IN THE ROOM TO HEAR THE ALARMS FROM THE MACHINE. A STAFF MEMBER MONITORING THE PATIENT AT A WORKSTATION WAS UNWARE REGARDING RESPONDING TO THE HEART MONITOR ALARM THAT WAS ON THE PATIENT. THE RESPIRATORY THERAPIST ENTERED THE ROOM AND FOUND THE PATIENT WITH A HEART RATE OF THIRTY BEATS PER MINUETE. THE STAFF ATTEMPTED TO STABILIZE THE PATIENT; HOWEVER, THE PATIENT EXPIRED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Death