BEUDAMED
    FDA Adverse Event Other Summary report: N

    ANESTHESIA MACHINE

    MDR report key: 2596778 · Received May 21, 2007

    Report

    Report Number
    2112667-2007-00025
    Event Type
    Other
    Date Received
    May 21, 2007
    Date of Event
    April 13, 2007
    Report Date
    May 21, 2007
    Manufacturer
    DATEX-OHMEDA
    Product Code
    BSZ
    PMA / PMN Number
    K061609
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION/CONCLUSION: AS STATED IN THE AISYS USERS MANUAL, PREOPERATIVE TESTS SECTION, STEP 1 OF THE LOW PRESSURE LEAK CHECK STATES, "OCCLUDE THE INSPIRATORY (RIGHT-HAND) PORT". ONCE THE TEST IS COMPLETED, THE MANUAL STATES THAT THE USER IS TO "OPEN THE INSPIRATORY PORT AND RECONNECT THE BREATHING CIRCUIT". THE PLUG, AS MENTIONED IN THE USER FILED MEDWATCH REPORT, IS USED FOR THE LOW PRESSURE LEAK CHECK TO OCCLUDE THE INSPIRATORY PORT. THE PLUG HAS BEEN DESIGNED IN SUCH A WAY TO BE OBVIOUS TO THE USER IF LEFT IN PLACE DURING AN ANESTHETIC. IT IS BRIGHT ORANGE IN COLOR AND HAS A LARGE RING/ FLANGE THAT PROTRUDES AROUND THE BREATHING CIRCUIT. IT ALSO IS MADE OF SILICONE AND THUS HAS A DIFFERENT FEEL THAN THE OTHER PORTION OF THE BREATHING SYSTEM. IN ADDITION TO THE VISUAL AND TACTILE CLUES, THERE IS A CASCADE OF HIGH PRIORITY SYSTEM ALARMS, BOTH AUDIBLE AND VISUAL, THAT OCCUR IF THE TEST DEVICE IS LEFT IN THE BREATHING CIRCUIT DURING A CASE. ADDITIONAL INFO FROM THE USER FACILITY REPORT: GE HEALTHCARE AISYS ANESTHESIA MACHINE. GAS-MACHINE, ANESTHESIA - BSZ. (B)(4).

    Description of Event or Problem · 1

    PER THE USER FILED MEDWATCH REPORT: "STUDENT RN ANESTHETIST WORKING WITH CRNA COMPLETED MACHINE CHECK. AFTER FINISHING LOW PRESSURE TEST, LEFT THE RED PLUG ATTACHED TO MACHINE AND CONNECTED THE CIRCUIT TO THE OTHER END OF THE PLUG (WHICH FIT PERFECTLY, THOUGH INAPPROPRIATELY). AFTER INDUCTION OF GENERAL ANESTHESIA, STAFF UNABLE TO VENTILATE THE PT. PT WAS URGENTLY INTUBATED, BUT THERE WAS NO CO2 WAVE FORM AND PT COULD NOT BE VENTILATED. CONSIDERING THE POSSIBILITY OF ESOPHAGEAL INTUBATION, ETT WAS REMOVED AND REPLACED UNDER DIRECT VISUALIZATION. AGAIN, THERE WAS NO CO2 WAVE FORM AND PT COULD NOT BE VENTILATED. PT WAS ONCE AGAIN EXTUBATED AND REINTUBATED, THEN MANUALLY VENTILATED WITH AN AMBU BAG AND AUXILIARY OXYGEN WHILE THE MACHINE WAS CHECKED. THE PLUG WAS FOUND AND REMOVED. THE PT WAS THEN VENTILATED BY THE MACHINE WITHOUT ANY PROBLEM. SURGERY CANCELED. PT EMERGED FROM ANESTHESIA, WAS OBSERVED OVERNIGHT AND DISCHARGED WITHOUT INCIDENT." THIS PLUG SHOULD BE RECALLED. THE DESIGN OF THIS PLUG IS VERY DANGEROUS, BECAUSE IT FITS PERFECTLY INTO THE MACHINE VENTILATOR TUBING AND THEREBY MAKES HUMAN ERROR POSSIBLE. THE SIDE OF THE PLUG THAT DOES NOT FIT INTO THE MACHINE SHOULD BE REDESIGNED SO IT WILL NOT FIT INTO THE TUBING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ANESTHESIA MACHINE AISYS BSZ DATEX-OHMEDA

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Required Intervention