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

Model Number	6677200
Medical Device Problem Codes	Fail-Safe Problem (2936); Output Problem (3005)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/23/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the anesthesia system had a leakage.There is currently no information whether it was during patient treatment or during system checkout.No patient harm as been reported.Manufacturer's reference number: (b)(4).
Additional Manufacturer Narrative
It was reported that the anesthesia system fails several tests during the system checkout.Our field service engineer (fse) investigate the system on-site and replaced the reflector o2 gas module.Following the replacement, the anesthesia system has been returned to clinical use and is functioning correctly.The replaced part were retained by the customer and not returned, and thus preventing further analysis.Upon reviewing the device log, the reported issues were confirmed, indicating faults in the reflector gas module or the nozzle unit inside the module.Our conclusion, based on the available information and log analysis, is that the replaced gas module resolved the issue however, the underlying cause of the issue can not be establish since the part was kept by the customer.
Event or Problem Description
Manufacturer's reference number: (b)(4).

• Brand Name: FLOW-I C20
• 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: 22824743
• Report Number: 8010042-2025-0001266
• Device Sequence Number: 4553679
• Product Code: BSZ
• UDI-Device Identifier: 07325710001349
• UDI-Public: (01)07325710001349(11)181004
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• 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): 08/18/2025

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: 6677200
• 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: 07/23/2025
• Supplement Date Received by Manufacturer: 11/04/2025
• Initial Report FDA Received Date: 08/18/2025
• Supplement Report FDA Received Date: 11/04/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/04/2018
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown