BEUDAMED
    FDA Adverse Event Other Summary report: N

    OHMEDA (BOC HEALTHCARE) TEC 6 DESFLURANE VAPORIZER

    MDR report key: 781269 · Received June 23, 2006

    Report

    Report Number
    MW1040985
    Event Type
    Other
    Date Received
    June 23, 2006
    Date of Event
    June 1, 2006
    Report Date
    June 2, 2006
    Manufacturer
    OHMEDA (BOC HEALTHCARE)
    Product Code
    CAD
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    FAILURE OF OHMEDA (BOC HEALTHCARE) TEC 6 DESFLURANE VAPORIZER TO DELIVER ANY DESFLURANE, WITHOUT ANY INDICATION OF ITS FAILURE. DIAL SET AT ABOUT 9%. "OPERATIONAL" GREEN LIGHT ON. WARM AND PLUGGED IN. ALL OTHER LIGHTS (NO OUTPUT-LOW AGENT-WARMUP-ALARM BATTERY LOW) NOT ILLUMINATED. FILL INDICATOR SHOWED FULL. DATEX-OHMEDA B/5 MONITOR SHOWED NO INHALATIONAL AGENT EXCEPT FOR THE NITROUS / OXYGEN. BECAUSE VITAL SIGNS WERE AT BASELINE, I WAS NOT OVERLY WORRIED ABOUT RECALL, BUT A BIS MONITOR THAT WAS GOING TO BE USED FOR THE NEXT CASE WAS AVAILABLE, AND SO I QUICKLY HOOKED IT UP. IT SHOWED A VALUE OF 81%, CONSISTENT WITH LACK OF DESFLURANE. PROPOFOL WAS GIVEN AND INHALATIONAL AGENTS CHANGED, WHICH THE MONITOR IMMEDIATELY DETECTED. LATER IN THE CASE, A SECOND TEC 6 WAS BROUGHT INTO THE ROOM AND TURNED ON. THE MONITOR IMMEDIATELY DETECTED THE DESFLURANE. I AM WAITING FOR THE REPORT ON THE APPARENTLY DEFECTIVE VAPORIZER. THE PATIENT, ON POST ANESTHESIA INTERVIEW, DID NOTE A VERY SHORT PERIOD OF NOT BEING ABLE TO MOVE AND HEARING VOICES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OHMEDA (BOC HEALTHCARE) TEC 6 DESFLURANE VAPORIZER DESFLURANE VAPORIZER CAD OHMEDA (BOC HEALTHCARE) * *

    Patients

    Seq Age Sex Outcome Treatment
    1 26 YR Other