BEUDAMED
    FDA Adverse Event Other Summary report: N

    FABIUS

    MDR report key: 494987 · Received November 5, 2003

    Report

    Report Number
    2517967-2003-00135
    Event Type
    Other
    Date Received
    November 5, 2003
    Date of Event
    October 9, 2003
    Report Date
    October 10, 2003
    Manufacturer
    DRAEGER MEDICAL, INC.
    Product Code
    BSZ
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT: THE PATIENT WAS INDUCED INTRAVENOUSLY AND INTUBATED. AN ISOFLURANCE VAPORIZER WHICH WAS CONNECTED IN A NON-ACTIVE PARKED POSITION ON THE SIDE OF THE ANESTHESIA MACHINE WAS SET TO DELIVER 2 TO 2.5% ISOFLURANE. THE ANESTHESIA WAS REPORTEDLY BEING PERFORMED BY A RESIDENT. AN AGENT ANALYZER WAS REPORTEDLY IN USE. AT APPROXIMATELY THREE HOURS IN TO THE CASE, THE ATTENDING ANESTHESIOLOGIST ENTERED THE OPERATING ROOM AND NOTICED THAT THE PATIENT WAS NOT BEING PROPERLY ANESTHETIZED. THE ATTENDING TURNED ON A SEVOFLURANE VAPORIZER, WHICH WAS IN THE ACTIVE POSITION ON THE ANESTHESIA MACHINE, AND THE PATIENT'S ELEVATED BLOOD PRESSURE AND HEART RATE RETURNED TO NORMAL. THE PROCEDURE WAS COMPLETED. THE PATIENT WAS REPORTED TO HAVE POST OPERATIVE RECALL OF THE PROCEDURE. IT WAS REPORTED THAT THE PATIENT RECEIVED PSYCHIATRIC POSTOPERATIVE THERAPY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FABIUS ANESTHESIA MACHINE BSZ DRAEGER MEDICAL, INC. GS NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other HEWLETT PACKARD CO2/AGENT MONITOR.