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

Model Number	6887700
Medical Device Problem Code	Output Problem (3005)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/01/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the anesthesia system generated a technical error code indicating an open safety valve.There was no patient harm.Manufacturer's reference number: (b)(4).
Event or Problem Description
Manufacturer's reference number: (b)(4).
Additional Manufacturer Narrative
The investigation into this complaint has been completed.The distributor¿s field service engineer investigated the system onsite.A complete set of device logs was downloaded and sent for evaluation.The inspiratory pressure transducer printed circuit board was replaced and returned for investigation.The system has been released for clinical use.The reported failure has not reoccurred.The returned pressure transducer pc board was inspected but no visual deviations or damages were found.It was installed in a reference system for testing.A successful system checkout was performed.The system was left on a test lung with adult settings for approximately 24 hours without any alarms or other issues.After the 24-hour test session, a new system checkout was performed.No deviations were noticed.The received logs confirm the reported issue with an error code indicating an open safety valve as well as an error code prompted by a difference larger than expected between the pressure measured by the fresh gas pressure transducer and the inspiratory pressure transducer.Since no faults or deviations could be reproduced during the investigation of the returned pressure transducer board, we have not been able to determine the true cause of the event, but it is possible that the replaced pressure transducer pcb caused or contributed to the reported issue.

• Brand Name: FLOW-C 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: 23861783
• Report Number: 8010042-2025-0001885
• Device Sequence Number: 9974154
• Product Code: BSZ
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K191027
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Y
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Company Representative
• Type of Report: Initial,Followup
• Report Date (Section B): 12/22/2025

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: 6887700
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/01/2025
• Supplement Date Received by Manufacturer: 09/21/2026
• Initial Report FDA Received Date: 12/22/2025
• Supplement Report FDA Received Date: 09/21/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/19/2025
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Age: 40 YR
• Patient Sex: Unknown
• Patient Weight: 110 LB