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

Model Number	6888520
Medical Device Problem Code	Output Problem (3005)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/07/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the anesthesia system had issues delivering the set level of fio2 during patient treatment.There was no patient harm.Manufacturer's reference number: (b)(4).
Event or Problem Description
Manufacturer's reference number: (b)(4).
Additional Manufacturer Narrative
Our investigation of this complaint has been completed.It was reported that there were excessive condensation in the inspiratory filter, and at times, the system did not deliver the set fio2.The customer reports the presence of condensation in the patient tubes and in the soda lime basket.Problem attributed to the use of antibacterial humidifier filters during long interventions with a very closed circuit, fresh gas flow 0.3 -0.5 l/min.The user was advised to use circuits with condensation collection cups and not to use humidifier filters for very long interventions.The anesthesia system does not present any technical faults and is also not affected by condensation.The device has passed the system checkout.The device has passed all performance and safety tests according to factory specifications.The device has been returned to the customer and authorized for clinical use.Based on the above information, no device malfunction has been determined.

• Brand Name: FLOW-I C20 ANESTHESIA SYSTEM
• 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: 23630168
• Report Number: 8010042-2025-0001695
• Device Sequence Number: 16071770
• Product Code: BSZ
• UDI-Device Identifier: 07325710010617
• UDI-Public: (01)07325710010617(11)250409
• 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): 11/24/2025

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: 6888520
• 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: 11/07/2025
• Supplement Date Received by Manufacturer: 03/09/2026
• Initial Report FDA Received Date: 11/24/2025
• Supplement Report FDA Received Date: 03/10/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/09/2025
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown