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

Model Number	6677200
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 while the anesthesia system was used for treatment, alarms indicating a leakage was generated.There was no patient harm.Manufacturer's reference #: (b)(4).
Additional Manufacturer Narrative
Our complaint investigation is finalized.Our field service engineer (fse) conducted an on-site investigation and confirmed the issue in the device log, however, multiple system checkout (sco) was successfully performed and the fse was unable to reproduce the issue.During the date of event and as a pre-caution, the customer swiped to another anesthesia system and proceed the treatment.They confirmed also that there was no interruption in ventilation.The involved anesthesia system passed sco when tested with new tubes and has since returned to normal clinical operation.A complete set of device logs was received.Evaluation of the logs shows that prior to and after the event a successful sco was performed.The log shows that leakage alarms and other clinical alarms were triggered during treatments, however, no leakage test was done between these treatments.The technical log has no recordings during this date which indicate the absence of technical malfunctions in the system.Our conclusion, based on the fse investigation and evaluation of the logs, is that the passed sco ensure correct system functionality, optimal performance, and patient safety.However, leakage occurring during use can result from various factors, such as breathing/patient tubes, sampling line positioning or filters.Therefore, we have not been able to determine the exact cause of the reported event.

• 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: 23592543
• Report Number: 8010042-2025-0001673
• Device Sequence Number: 18686761
• Product Code: BSZ
• UDI-Device Identifier: 07325710001349
• UDI-Public: (01)07325710001349(11)170707
• Combination Product (Y/N): N
• Initial Reporter Country: PO
• 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
• Report Date (Section B): 11/19/2025

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?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/28/2025
• Initial Report FDA Received Date: 11/19/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/07/2017
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown