BEUDAMED
    FDA Adverse Event Death Summary report: N

    ESPRIT

    MDR report key: 514146 · Received March 4, 2004

    Report

    Report Number
    2031642-2004-00004
    Event Type
    Death
    Date Received
    March 4, 2004
    Date of Event
    February 2, 2004
    Manufacturer
    RESPIRONICS CALIFORNIA, INC.
    Product Code
    CBK
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    RESPIRATORY THERAPIST

    Narratives

    Description of Event or Problem · 1

    CUSTOMER INFORMED MANUFACTURER SALES REP THAT IN 2004 A PT BECAME DISCONNECTED FROM THE VENTILATOR. THE BREATHING CIRCUIT WAS REPORTED TO HAVE DISCONNECTED AT THE PT AIRWAY. THE PT WAS DISCOVERED TO BE DISCONNECTED BY A FAMILY MEMBER, WHO REPORTED THAT THE VENTILATOR WAS ALARMING AT THE TIME OF THE DISCONNECT. THE PT WENT INTO FULL ARREST, WAS CODED AND RESUSCITATED. THE PT WAS PLACED BACK ON THE VENTILATOR. FOLLOW-UP EEG REPORTEDLY NOTED DECREASED BRAIN ACTIVITY. THE CUSTOMER SWITCHED THE PT TO ANOTHER VENTILATOR. THE PT WAS LATER REMOVED FROM VENTILATORY SUPPORT AND DIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ESPRIT VENTILATOR CBK RESPIRONICS CALIFORNIA, INC. V1000 *

    Patients

    Seq Age Sex Outcome Treatment
    1 26 YR Death