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

Model Number	6677200
Medical Device Problem Codes	Output Problem (3005); Pressure Problem (3012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/15/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the anesthesia system generated an alarm indicating an open safety valve during patient treatment.There was no patient harm.Manufacturer's reference number: (b)(4).
Additional Manufacturer Narrative
Our investigation of this complaint has been completed.It was initially stated that the technical error code indicating an open safety valve was generated during patient treatment.Additional information states that the anesthesia system was in standby mode while the patient was connected to a heart-lung machine.We have not received any additional information about the setup during the surgery.Our field service engineer investigated the anesthesia system at the hospital.The reported issue was solved by cleaning the safety valve membrane.The patient system and water trap from customer stock were replaced.After successful testing, the anesthesia system was cleared for clinical use.The reported failure can be verified in the supplied log.The log shows that the technical error code was generated when the anesthesia system was in standby mode.Apart from the reported issue having been solved by cleaning the safety valve membrane, no additional cause of the event has been determined.
Event or Problem Description
Manufacturer's reference number: (b)(4).

• 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: 23400944
• Report Number: 8010042-2025-0001584
• Device Sequence Number: 10179433
• Product Code: BSZ
• UDI-Device Identifier: 07325710001349
• UDI-Public: (01)07325710001349(11)160303
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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): 10/28/2025

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?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/15/2025
• Supplement Date Received by Manufacturer: 01/26/2026
• Initial Report FDA Received Date: 10/28/2025
• Supplement Report FDA Received Date: 01/26/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/20/2026
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown