MAUDE Adverse Event Report: MAQUET CRITICAL CARE AB FLOW-I C20 ANESTHESIA SYSTEM; GAS-MACHINE, ANESTHESIA

Model Number	6888520
Medical Device Problem Code	Output Problem (3005)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the anesthesia system had a leakage.There is no information whether the event occurred during system checkout or during patient treatment.No patient harm was reported.Manufacturer's reference number: (b)(4).
Event or Problem Description
Manufacturer's reference number: (b)(4).
Additional Manufacturer Narrative
The investigation of this complaint has been completed.It was initially reported that there was leakage in the anesthesia system.Additional information states that the reported leakage occurred during a system checkout prior to use.We have not received any information about any circumstances and cause of the leakage.The logs have not been received to confirm the issue.Based on the above information, our conclusion is that the reported leakage will be detected during the system checkout (as it was in this case).A system checkout must always be performed prior connecting the anesthesia system to a patient.If the system checkout fails, the anesthesia system should not be used before remedy has been performed.

• Brand Name: FLOW-I C20 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: 22989921
• Report Number: 8010042-2025-0001375
• Device Sequence Number: 9090203
• Product Code: BSZ
• UDI-Device Identifier: 07325710010617
• UDI-Public: (01)07325710010617(11)240822
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K191027
• Number of Events Summarized: 1
• Summary Report (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): 09/08/2025

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: 6888520
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/19/2025
• Supplement Date Received by Manufacturer: 11/21/2025
• Initial Report FDA Received Date: 09/08/2025
• Supplement Report FDA Received Date: 12/01/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/22/2024
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown