BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NARCOMED 6000

    MDR report key: 285965 · Received July 13, 2000

    Report

    Report Number
    MW1019295
    Event Type
    Injury
    Date Received
    July 13, 2000
    Date of Event
    July 7, 2000
    Report Date
    July 13, 2000
    Manufacturer
    DRAEGER MEDICAL, INC.
    Product Code
    BSZ
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    PT UNDERGOING THORACOTOMY UNDER GENERAL ANESTHESIA USING A NARCOMED 6000 ANESTHESIA MACHINE. REQUIRED SUCTIONING OF SECRETIONS IN ENDOTRACHEAL TUBE. SUCTIONING DONE WITH FLEXIBLE CATHETER INSERTED VIA A SIDEPORT IN THE ENDOTRACHEAL TUBE CONNECTOR DURING VENTILATION IN PRESSURE VENTILATION MODE. RATE 32, PIP 29, PEEP 4. SUCTIONING CAUSED THE VENTILATOR TO ALARM "NEGATIVE PRESSURE", THE VENTILATOR STOPPED FUNCTIONING. THE MONITOR SCREEN SAID "RESETTING PISTON" BUT THE MACHINE NEVER RESET. THE MACHINE WAS "DEAD". RPTR COULD NOT CONVERT TO THE MANUAL VENTILATION MODE WITH THE USUAL BUTTON. RPTR PRESSED THE RED MANUAL OVERRIDE BUTTON, BUT WITH NO EFFECT. RPTR ENDED UP BLOWING ON THE ETT WITH THEIR MOUTH (COVERED BY THEIR MASK) FOR A FEW BREATHS UNTIL AN AMBU BAG COULD BE CONNECTED. THE ANESTHESIA MACHINE WAS TURNED OFF, THEN TURNED BACK ON AND IT WORKED PERFECTLY THEREAFTER. AFTER THE CASE THE PROBLEM WAS REPRODUCED BY DOING THE SAME SUCTIONING PROCESS. THE REP FROM DRAGER INDICATED THAT THIS KNOWN PROBLEM CAN BE AVOIDED BY SUCTIONING ONLY IN THE"SPONTANEOUS/MANUAL VENTILATION" MODE OR BY USING LESS POWERFUL SUCTION. THE PT SUFFERED NO COMPLICATION OTHER THAN SLIGHT, VERY TRANSIENT DECREASE IN OXYGEN SATURATION. THIS VENTILATOR IS ON AN ANESTHESIA MACHINE, BUT RPTR UNDERSTANDS THAT THE SAME VENTILATOR MECHANISM IS USED ON THE DRAGER ICU VENTILATORS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NARCOMED 6000 ANESTHESIA MACHINE BSZ DRAEGER MEDICAL, INC. 6000 *

    Patients

    Seq Age Sex Outcome Treatment
    1 12 YR Required Intervention