BEUDAMED
    FDA Adverse Event Death Summary report: N

    NARKOMED

    MDR report key: 256186 · Received December 23, 1999

    Report

    Report Number
    2517967-1999-00025
    Event Type
    Death
    Date Received
    December 23, 1999
    Date of Event
    November 23, 1999
    Report Date
    December 23, 1999
    Manufacturer
    DRAEGER MEDICAL, INC.
    Product Code
    GKZ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT: THE SURGERY ON 11/23/99 WAS FOR AN INTERNAL FIXATION OF THE RIGHT ANKLE. THE PT WAS REPORTEDLY STABLE AT THE BEGINNING OF THE CASE AND WAS BEING VENTILATED WITH AN AMBU BAG. IT WAS REPORTED THAT THE OR STAFF WAS IMMEDIATELY AWARE OF A PROBLEM AFTER THE PT WAS REMOVED FROM THE TRANSPORT VENTILATION. IT IS UNKNOWN WHETHER MANUAL OR AUTOMATIC VENTILATION WAS USED ON THE ANESTHESIA MACHINE. THE SURGEON NEVER CAME INTO THE ROOM TO START THE CASE. THE PROCEDURE STARTED AT 7:15 AND THE PT WAS PRONOUNCED DEAD AT 8:40. ALTHOUGH IT WAS REPORTED THAT A PREUSE CHECK WAS DONE ON THE MACHINE, IT IS UNCLEAR WHETHER THERE IS ANY DOCUMENTED RECORD OF THE CHECK. IT WAS REPORTED THAT PER THE MEDICAL EXAMINER'S REPORT, THE CAUSE OF DEATH WAS A BILATERAL PNEUMOTHORAX WITH COMPARTMENT SYNDROME. THE PHYSICIAN IN CHARGE OF QUALITY AT THE HOSPITAL REPORTED THAT THE DEATH WAS DUE TO HUMAN ERROR CAUSING MASSIVE BAROTRAUMA. THE HOSPITAL WOULD NOT PROVIDE ANY ADDITIONAL INFO ABOUT THE EVENT OR THE PT, AND MFR HAS NOT RECEIVED A COPY OF THE USER'S MEDWATCH REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NARKOMED ANESTHESIA MACHINE GKZ DRAEGER MEDICAL, INC. NM2B NA

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Death