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

Model Number	6677200
Medical Device Problem Code	Decrease in Pressure (1490)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/04/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that while the anesthesia system was used for treatment, the set peep (positive end expiratory pressure) level could not be reached and the system reported a leakage.There was no patient harm.Manufacturer's reference#: (b)(4).
Event or Problem Description
Manufacturer's reference #: (b)(4).
Additional Manufacturer Narrative
The investigation of this complaint has been completed.The system was investigated on-site by our field service engineer.The test was performed with new breathing circuit, water trap and sampling line since the breathing circuit used at the time of the event was not left on the system.The system checkout was successfully performed.The system device logs were received for evaluation.The received logs were not complete.The logs from the time of event were not available, the logs had been erased during a software update that was performed after the event.The evaluation of the test log after the software update confirms that the system checkout was successfully performed.The reported event stating that the set peep level was not reached and that alarms indicating a leakage were generated could not be confirmed in the logs since the recordings from the event were not available.The breathing circuit used at the time of the event may be involved in the reported failure but that cannot be confirmed since it was not available for testing.Our conclusion, based on the field service engineer investigation, is that there was no technical malfunction with the system at the time of the reported event.The root cause of the reported leakage has not been determined.

• 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: 23691832
• Report Number: 8010042-2025-0001743
• Device Sequence Number: 10375258
• Product Code: BSZ
• UDI-Device Identifier: 07325710001349
• UDI-Public: (01)07325710001349(11)170421
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• 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): 12/02/2025

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
• Device Catalogue Number: 6677200
• 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: 11/04/2025
• Supplement Date Received by Manufacturer: 02/10/2026
• Initial Report FDA Received Date: 12/02/2025
• Supplement Report FDA Received Date: 02/10/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/21/2017
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown