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	07/22/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during patient treatment, the anesthesia system generated alarms for high airway pressure.There was no patient harm.Manufacturer's reference number: (b)(4).
Additional Manufacturer Narrative
The investigation of this complaint has been completed.The anesthesia system was investigated at the hospital by our field service engineer.It was concluded that the air gas module was faulty and needed to be replaced.After the replacement, the anesthesia system was successfully tested and cleared for clinical use.The air gas module was returned for investigation and tested in our laboratory environment.A complete set of device logs was received, in which the reported issues could be verified.During testing of the returned air gas module, the reported issues could be reproduced.During a ventilation session, several alarms for airway pressure: high, fio2: low, expiratory minute volume: high etc.Were generated.The safety valve opened and there was no ventilation.The air gas nodule was investigated further.It was found that the inspiratory valve flow controller pc board inside the gas module was faulty.A reference inspiratory valve flow controller pc board was installed in the returned gas module for testing.All tests passed during a system checkout and a successful ventilation session was conducted.No faults or deviations could be generated.Our conclusion is that one or several faulty components on the inspiratory valve flow controller pc board caused the reported issue.
Event or Problem Description
Manufacturer's reference number: (b)(4).

• 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: 22685118
• Report Number: 8010042-2025-0001199
• Device Sequence Number: 8864384
• Product Code: BSZ
• UDI-Device Identifier: 07325710010617
• UDI-Public: (01)07325710010617(11)230310
• Combination Product (Y/N): N
• Initial Reporter Country: NO
• 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): 08/01/2025

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: 07/23/2025
• Supplement Date Received by Manufacturer: 01/13/2026
• Initial Report FDA Received Date: 08/01/2025
• Supplement Report FDA Received Date: 01/16/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/10/2023
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown