MAUDE Adverse Event Report: DATEX-OHMEDA, INC. AISYS; ANESTHESIA GAS MACHINE

Model Number	CS2 WITH ET CONTROL
Medical Device Problem Code	Insufficient Flow or Under Infusion (2182)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/12/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A ge healthcare service representative performed a checkout of the system and confirmed the reported issue.The o2 regulator knob screw was tightened to resolve the issue.Block a: no report of patient involvement.Legal manufacturer: hcs madison - 3030 ohmeda dr, usa madison, wi 53718.
Event or Problem Description
It was reported that there was a malfunction resulting in prolonged insufficient oxygen (o2) concentration or fresh gas flow during pre-use checkout.There was no patient involvement.

• Brand Name: AISYS
• Common Device Name: ANESTHESIA GAS MACHINE
• Manufacturer (Section D): DATEX-OHMEDA, INC.; 3030 ohmeda dr,; madison, WI 53718
• Manufacturer (Section G): DATEX-OHMEDA, INC.; 3030 ohmeda dr,; madison, WI 53718
• Manufacturer Contact: michaela moore ; 3030 ohmeda drive; madison, WI 53718
• MDR Report Key: 24802607
• Report Number: 2112667-2026-02304
• Device Sequence Number: 21503406
• Product Code: BSZ
• UDI-Device Identifier: 00195278588128
• UDI-Public: (01)00195278588128(11)241209
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K170872
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 04/07/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: CS2 WITH ET CONTROL
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/12/2026
• Initial Report FDA Received Date: 04/07/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/09/2024
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown