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

Model Number	6887700
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	10/24/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The anesthesia system failed the pressure transducer test during system checkout.There was no patient involvement.Manufacturer's reference number: (b)(4).
Event or Problem Description
Manufacturer's reference number: (b)(4).
Additional Manufacturer Narrative
Our investigation of this complaint has been completed.Our field service engineer investigated the anesthesia system at the hospital.The reported failure was reproduced.A complete technical inspection of the device was done.The tightness check of the luer-lock connections of the pressure sensor tubes, as well as the connections of the pc boards were performed.The fault was resolved by these actions.The device successfully passed all pre-use and safety tests.The device was returned to the customer and authorized for clinical use.The evaluation of the received logs confirm that the fresh gas pressure transducer test failed due to a too low zero pressure offset measured at the test.The flow transducer test failed due to an expiratory flow transducer offset having measured too low.The patient cassette (that contains the expiratory flow transducer) measured a large negative flow due to the offset failure.Several other sub tests also failed as a consequence of this failure.The pressure transducer pcb is part of the pressure measuring in the system.A faulty pressure transducer pcb may lead to inaccuracy in pressure measurement.This will be detected during system checkout and high priority alarms will be generated if the failure occurs during treatment.Apart from being able to confirm the zero-pressure offset failure of the fresh gas pressure transducer and the patient cassette, most likely caused several of the other system checkout sub tests to fail, we have not been able to with certainty confirm the true cause since the reported issues were solved by tightening the luer-lock connections of the pressure sensor tubes as well as the re-connections of the pc boards.

• 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: 23422051
• Report Number: 8010042-2025-0001596
• Device Sequence Number: 9798478
• Product Code: BSZ
• UDI-Device Identifier: 07325710009765
• UDI-Public: (01)07325710009765(11)190814
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• 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): 10/30/2025

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: 10/24/2025
• Supplement Date Received by Manufacturer: 01/26/2026
• Initial Report FDA Received Date: 10/30/2025
• Supplement Report FDA Received Date: 01/26/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/14/2019
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown