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

Model Number	6677200
Medical Device Problem Code	Failure of Device to Self-Test (2937)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/06/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the anesthesia system failed the pressure transducer test during system checkout.There was no patient involvement.Manufacturer's reference number: (b)(4).
Additional Manufacturer Narrative
Our investigation of this complaint has been completed.Our field service engineer investigated the system at the hospital.The investigation found that the pressure transducer test failed during the system checkout.The issue was solved by replacing the inspiratory and the fresh gas pressure transducer pcb.The anesthesia system was successfully tested and was cleared for clinical use.Both pressure transducer pcb:s were returned for investigations.No deviations or damages could be noticed when visually inspected.The two pcb:s were installed in reference anesthesia system and a successful system checkout was performed.A long term ventilation test (lasting approximately 48 hours) was conducted.No alarms or deviations were noticed.After 48 hour ventilation test, a new successful system checkout was performed.Further investigations of the pressure sensors on the pcb:s found that the measured resistance in the pressure sensors bridge (wheatstone bridge) were normal.A complete set of device logs was received.The evaluation of the logs show that the system checkout failed due to having an inspiratory pressure transducer gain correction factor out of range with a very small margin.The fresh gas pressure transducer had no issues.We have not been able to determine the true cause of the reported system checkout failure.
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: 23366184
• Report Number: 8010042-2025-0001569
• Device Sequence Number: 15671094
• Product Code: BSZ
• UDI-Device Identifier: 07325710001349
• UDI-Public: (01)07325710001349(11)191014
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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): 10/23/2025

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: 10/06/2025
• Supplement Date Received by Manufacturer: 06/04/2026
• Initial Report FDA Received Date: 10/23/2025
• Supplement Report FDA Received Date: 06/16/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/14/2019
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown