MAUDE Adverse Event Report: MAQUET CRITICAL CARE AB FLOW-I C40 ANESTHESIA SYSTEM; GAS-MACHINE, ANESTHESIA

Model Number	6888540
Medical Device Problem Codes	Contamination (1120); Medical Gas Supply Problem (2985)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/19/2025
Type of Reportable Event	Malfunction
Event or Problem Description
During the inspection of the anesthesia workstation it was discovered that the air gas module was contaminated with water.There was no patient harm.Manufacturer's ref.#: (b)(4).
Additional Manufacturer Narrative
The investigation of this complaint has been completed.According to the received information this was detected during system checkout.There was no patient involvement.Our field service engineer investigated the system on-site and presence of water in the air supply inlet line was detected.When the hose was disconnected a massive expulsion of water mixed with air was observed.Water had entered the anesthesia system through the supplied pressure from the hospital's central air compressor.The hospital staff was informed, and the air intakes of all operating rooms were checked.During the investigation it was found that the air gas module was damaged due to the water that had entered the system.In addition, the patient cassette also needed to be replaced.These parts were replaced and the preventive maintenance (pm) including installation of the pm kit was performed.The system was thereafter successfully tested and released for clinical use.The air gas module regulates the inspiratory gas flow and gas mixture.The water contamination in the air gas module most likely affected the delta pressure sensor mounted on a printed circuit board inside the air gas module.The delta pressure sensor is part of the flow measuring in the gas module.A fault in the delta pressure sensor leads to inaccurate gas flow regulation which will be detected during system checkout and alarms will be activated if the failure occurs during treatment.According to the user's manual, maximum levels of water (h2o < 7 g/m3) in the supplied gases to the anesthesia system must not be exceeded.The conclusion is that the anesthesia system did not fail to meet its specification, as the source of water contamination is moist air gas from the hospital's central air compressor.
Event or Problem Description
Manufacturer's reference #: (b)(4).

• Brand Name: FLOW-I C40 ANESTHESIA SYSTEM
• Common Device Name: GAS-MACHINE, ANESTHESIA
• Manufacturer (Section D): MAQUET CRITICAL CARE AB; roentgenvagen 2; solna
• Manufacturer (Section G): MAQUET CRITICAL CARE AB; roentgenvagen 2; solna
• Manufacturer Contact: caroline kabbabe ; roentgenvagen 2; solna
• MDR Report Key: 22370198
• Report Number: 8010042-2025-0001007
• Device Sequence Number: 20837301
• Product Code: BSZ
• UDI-Device Identifier: 07325710010631
• UDI-Public: (01)07325710010631(11)230627
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• PMA/510(K) Number: K191027
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/01/2025

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: 6888540
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/19/2025
• Supplement Date Received by Manufacturer: 09/17/2025
• Initial Report FDA Received Date: 07/01/2025
• Supplement Report FDA Received Date: 09/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/27/2023
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown