BEUDAMED
    FDA Adverse Event Other Summary report: N

    AISYS

    MDR report key: 951561 · Received November 19, 2007

    Report

    Report Number
    2112667-2007-00048
    Event Type
    Other
    Date Received
    November 19, 2007
    Date of Event
    October 23, 2007
    Report Date
    November 19, 2007
    Manufacturer
    DATEX-OHMEDA INC.
    Product Code
    BSZ
    PMA / PMN Number
    K061609
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SD, 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."

    Description of Event or Problem · 1

    CUSTOMER REPORTED A STUDENT PERFORMED A CHECKOUT OF THE MACHINE AND INADVERTENTLY LEFT THE TEST PLUG IN THE INSPIRATORY LIMB. THE CASE STARTED, AND THE CUSTOMER REPORTEDLY EXPERIENCED DIFFICULTY VENTILATING THE PT. THE PT WAS REPORTEDLY TREATED FOR BRONCHIAL SPASMS. CUSTOMER SUBSEQUENTLY NOTED THE RED TEST PLUG, REMOVED IT, AND MANUAL VENTILATION STARTED TO WORK CORRECTLY. THERE WAS NO REPORTED PT INJURY. THE PLUG 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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AISYS ANESTHESIA MACHINE BSZ DATEX-OHMEDA INC. 2900-00001-000

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR