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)
Date of Event	07/14/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that while the anesthesia system was used for treatment, a leakage occurred.The patient was moved to another system.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 the reported failure in this complaint has been completed.Our field service engineer (fse) investigated the issue on-site but was unable to reproduce the problem.However, it was noted that the customer had already replaced the patient/breathing tubes along with the patient cassette.The used cassette had been thoroughly cleaned by the customer and successfully passed several system checkouts (sco).Additionally, the preventive maintenance (pm+) was performed as part of the scheduled service.Following these actions, the system was verified to be functioning normally during clinical use.A complete set of device logs was received for review.Evaluation of the logs showed that successful sco's were performed both prior to and after the reported event, and leakage tests were also conducted between treatments.Leakage alarm was triggered accompanied by other clinical alarms.Our conclusion, based on the log evaluation and the fse¿s on-site findings, is that the reported issue was resolved by replacing the patient cassette and patient/breathing tubes.However, it is unknown what type of the breathing circuit/patient tubes that was used.

• 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: 22540205
• Report Number: 8010042-2025-0001128
• Device Sequence Number: 12880898
• Product Code: BSZ
• UDI-Device Identifier: 07325710001349
• UDI-Public: (01)07325710001349(11)171222
• Combination Product (Y/N): N
• Initial Reporter Country: FI
• 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): 07/18/2025

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?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/14/2025
• Supplement Date Received by Manufacturer: 10/15/2025
• Initial Report FDA Received Date: 07/18/2025
• Supplement Report FDA Received Date: 10/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/22/2017
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown