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	11/28/2025
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 #: (b)(4).
Additional Manufacturer Narrative
The investigation of this complaint has been completed.Our field service engineer investigated the anesthesia system at the hospital.The inspiratory pressure transducer pcb was found faulty and was replaced.After successful testing, the anesthesia system was cleared for clinical use.The device logs have not been received.The replaced part was kept by the customer and cannot be investigated further.Our conclusion into this matter is that the replaced inspiratory pressure transducer pcb caused the reported fault.

• 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: 23816528
• Report Number: 8010042-2025-0001809
• Device Sequence Number: 9974366
• Product Code: BSZ
• UDI-Device Identifier: 07325710009765
• UDI-Public: (01)07325710009765(11)191125
• Combination Product (Y/N): N
• Initial Reporter Country: PL
• 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): 12/11/2025

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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/28/2025
• Supplement Date Received by Manufacturer: 03/05/2026
• Initial Report FDA Received Date: 12/16/2025
• Supplement Report FDA Received Date: 03/06/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/25/2019
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown