MAUDE Adverse Event Report: MAQUET CRITICAL CARE AB FLOW-C; 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	11/04/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the anesthesia system failed in the system checkout in the leakage test.According to the logs the pressure transducer test also failed.There was no patient involvement.Manufacturer's reference #: (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 system on-site and reproduced the reported failure.The inspiratory pressure transducer pcb was found faulty and was replaced.The inspiratory pressure transducer pcb was retained by the customer and not returned for investigation.The system device logs were sent for evaluation.The evaluation of the received system device logs confirms the reported failure.The leakage test failed due to excessive leakage.In the following complete system checkout the pressure transducer test also failed due to the gain correction factor for the inspiratory pressure transducer pcb was outside of allowed limit.The pressure transducer pcb has a factory calibrated gain correction factor value that normally is around 1.During system checkout the gain correction factor is measured and if the measured value is outside the allowed limit (± 0.05 from factory calibrated gain correction factor), the test will fail.The leakage test failed as a consequence of the inaccuracy in the pressure measurement.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.Our conclusion is that the replaced inspiratory pressure transducer pcb was the cause of the reported failure.

• Brand Name: FLOW-C
• 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: 23691966
• Report Number: 8010042-2025-0001745
• Device Sequence Number: 13334171
• Product Code: BSZ
• UDI-Device Identifier: 07325710009765
• UDI-Public: (01)07325710009765(11)230811
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• 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): 12/02/2025

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
• Device Catalogue Number: 6887700
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/04/2025
• Supplement Date Received by Manufacturer: 02/10/2026
• Initial Report FDA Received Date: 12/02/2025
• Supplement Report FDA Received Date: 02/10/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/11/2023
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown