Description of Event or Problem · 0
N2O GAS LEAKAGE REPORTED ON 4 ANESTHESIA SYSTEMS WITH MODEL AISYS CS2. THE ORIGINAL DEVICE REPORTED AND N2O GAS LEAKAGE IN JULY 2024 (DEVICE SN (B)(6)). WE CONTACTED GE AND REPLACED THE GAS MODULE. THIS INITIAL REPORTED ISSUE WAS ADDRESSED A REGULAR DEVICE REPAIR NEED. ON DECEMBER 31ST, 2024, CLINICAL STAFF ENTERED ANOTHER WORK ORDER FOR A 2ND ANESTHESIA (WITH SN: (B)(6)) N2O GAS LEAKAGE. WE CONTACTED GE AND THE N2O GAS MODULE WAS REPLACED ON JANUARY 15TH, 2025. ALL OF OUR REMAINING ELEVEN ANESTHESIA UNITS WERE TESTED FOR N2O LEAKAGE IN JANUARY 2025 AND NO ISSUES WERE FOUND. ON MARCH 1ST, 2025 BIOMEDICAL ENGINEERING RECEIVED A WORK ORDER REQUEST FOR A N2O GAS LEAKAGE FOR OUR ANESTHESIA AYSIS CS2 UNIT (WITH SN: (B)(6)). GE FIELD SERVICE ENGINEER REPLACED THE N2O MODULE ON APRIL 11, 2025. ON MARCH 17, 2025, BIOMEDICAL ENGINEERING RECEIVED A WORK ORDER FOR A FOURTH ANESTHESIA AYSIS CS2 (WITH SN (B)(6)). WE ADDRESSED THE GAS LEAKAGE ON MARCH 20, 2025. IN TOTAL WE HAVE ENCOUNTERED FOUR REPORTED N2O GAS MODULE LEAKAGE IN FOUR ANESTHESIA UNITS: SNS: SN (B)(6). IN EACH INSTANCE THE N2) GAS MODULES WERE REPLACED AND THEN TESTED FOR FULL FUNCTIONALITY BY A GE FIELD SERVICE ENGINEER. REFERENCE REPORT: MW5169687, MW5169689, MW5169690.