BEUDAMED
    FDA Adverse Event Other Summary report: N

    TEC 6 VAPORIZER

    MDR report key: 758816 · Received September 7, 2006

    Report

    Report Number
    MW1040312
    Event Type
    Other
    Date Received
    September 7, 2006
    Date of Event
    June 1, 2006
    Report Date
    August 31, 2006
    Manufacturer
    DATEX-OHMEDA INC
    Product Code
    CAD
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    FEMALE FOR LAPAROSCOPIC CHOLECYSTECTOMY. STANDARD INTRAVENOUS INDUCTION. MASK VENTILATION AND INTUBATION UNEVENTFUL. OXYGEN AND NITROUS OXIDE WERE SET AT 0.5 & 0.5 LPM. THE DESFLURANE WAS TURNED BACK ON (IT HAD ALSO BEEN ON WHILE WAITING FOR THE MUSCLE RELAXANT TO TAKE EFFECT PRIOR TO INTUBATION). WITHIN FIRST 5 MINUTES, THE DATEX-OHMEDA S/5 MONITOR WAS NOTED TO NOT BE DETECTING DESFLURANE. DESFLURANE TEC 6 VAPORIZER WAS SET ON 9%, "OPERATIONAL" GREEN LIGHT ILLUMINATED; THE OTHER LIGHTS (NO OUTPUT, LOW AGENT, WARM-UP, ALARM BATTERY LOW) WERE OFF, FILL INIDICATOR SHOWED FULL. VITAL SIGNS WERE AT BASELINE. THE SURGEONS WERE ASKED TO WAIT ON INCISION. A BIS MONITOR WAS QUICKLY APPLIED WHICH READ AT 80%. ADD'L PROPOFOL WAS GIVEN, SEVOFLURANE WAS STARTED. THE CASE PROCEEDED. SUBSEQUENT TESTING SHOWED FAILURE OF THE ORIGINAL TEC 6 VAPORIZER TO DELIVER ANY DESFLURANE, EVEN THOUGH THE TEC 6 WARNING SYSTEM GAVE NO INDICATION OF ITS FAILURE. POSTOPERATIVE INTERVIEW WITH THE PT SUGGESTED TRANSIENT INTRAOPERATIVE RECALL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TEC 6 VAPORIZER DESFLURANE VAPORIZER CAD DATEX-OHMEDA INC * *

    Patients

    Seq Age Sex Outcome Treatment
    1 26 YR Other