BEUDAMED
    FDA Adverse Event Death Summary report: N

    NARKOMED

    MDR report key: 1845338 · Received September 24, 2010

    Report

    Report Number
    2510954-2010-00008
    Event Type
    Death
    Date Received
    September 24, 2010
    Date of Event
    August 6, 2010
    Report Date
    August 26, 2010
    Manufacturer
    DRAGER MEDICAL SYSTEMS, INC. (PNC)
    Product Code
    BSZ
    PMA / PMN Number
    K033498
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION INTO THE REPORTED EVENT IS UNDERWAY, BUT NOT YET COMPLETE. RESULTS WILL BE PROVIDED IN A FOLLOW UP REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT: THERE WAS A PT INCIDENT WITH A NARKOMED 6400 ANESTHESIA MACHINE. THE REPORTED EVENT OCCURRED ON (B)(6), 2010 AT APPROXIMATELY 7:30 AM. THE INITIAL REPORTER, REPORTED THAT THE CASE WAS STARTED AND THE PT WAS INTUBATED AND VENTILATED. THE OPERATING ROOM RESPIRATORY THERAPIST INDICATED THAT THE PT WAS VENTILATED IN VOLUME CONTROL MODE. DURING THE CASE SOMETHING HAPPENED; THE ANESTHESIA MACHINE ALARMED (VISUAL AND AUDIBLE) AND STOPPED VENTILATING. THE PT EXPIRED. THE ANESTHESIA MACHINE WAS THEN MOVED TO CLINICAL ENGINEERING AND CHECKED BY THE INITIAL REPORTER. THE INITIAL REPORTER, INDICATED THAT ALL APPEARED OK WITH NARKOMED 6400.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NARKOMED ANESTHESIA MACHINE BSZ DRAGER MEDICAL SYSTEMS, INC. (PNC) 6400 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Death