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

Model Number	6677200
Medical Device Problem Code	Failure of Device to Self-Test (2937)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/19/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the safety valve test failed during the system checkout.There was no patient involvement.Manufacturer's reference number: (b)(4).
Additional Manufacturer Narrative
Our handling of this complaint has been completed.The anesthesia system was investigated at the hospital by our field service engineer.The investigation found a faulty volume reflector.After replacement of the volume reflector, the anesthesia system was successfully tested and was cleared for clinical use.The replaced volume reflector has been scrapped and cannot be investigated further.A set of device logs was received but the reported event date is not covered by the test log, hence the reported issue cannot be confirmed.Based on the above information, the cause of the reported issue was a leak in the volume reflector.
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: 23541230
• Report Number: 8010042-2025-0001654
• Device Sequence Number: 9283788
• Product Code: BSZ
• UDI-Device Identifier: 07325710001349
• UDI-Public: (01)07325710001349(11)190311
• Combination Product (Y/N): N
• Initial Reporter Country: TH
• 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): 11/13/2025

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: 10/15/2025
• Supplement Date Received by Manufacturer: 03/16/2026
• Initial Report FDA Received Date: 11/13/2025
• Supplement Report FDA Received Date: 03/18/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/11/2019
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown