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

Model Number	6888520
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	11/06/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the ventilator failed pressure transducer test during pre-use check.There was no patient involvement.Manufacturer's reference #: (b)(4).
Additional Manufacturer Narrative
Our investigation of the reported failure in this complaint has been completed.A complete set of device logs was received.The pressure transducer test failed due to the fresh gas pressure transducer zero pressure offset being out of range; the measured zero pressure offset was 23 mv.The pressure transducer pcb has a factory calibrated zero pressure offset value that normally is 2 ± 0.5 v.During system checkout (sco) the pressure offset value is measured and if the measured value is outside the allowed limit (±300mv from factory calibrated value) the test will fail.The evaluation of the logs shows further that the system was used despite the failed system checkout.A technical error code indicting airway pressure sensor error and airway pressure high alarm were generated.Thereafter a new sco was successfully performed, however, the technical error reoccurred during the next treatment.The distributor's field service engineer (fse) investigated the system on-site.The reported failure was confirmed and the fresh gas pressure transducer was replaced.Following the intervention, the issue was resolved, the system successfully passed sco and was cleared for clinical use.The replaced part was sent for technical investigation to replicate the reported failure.No deficiencies were found during the visual inspection of the pcb or during testing in a reference machine.Several successful system checkouts were performed before and after the system was ran in ventilation mode with a test lung.The system was run in ventilation mode continuously for 24 hours.The zero pressure offset values measured during the investigation, indicates a slight imbalance in the pressure sensor on the pressure transducer pcb which indicates that the pressure sensor is not functioning correctly.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 reported failure was due to an offset drift and imbalances in the pressure sensor mounted on fresh gas pressure transducer pcb.
Event or Problem Description
Manufacturer's reference #: (b)(4).

• Brand Name: FLOW-I C20 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: 23580067
• Report Number: 8010042-2025-0001671
• Device Sequence Number: 9223316
• Product Code: BSZ
• UDI-Device Identifier: 07325710010617
• UDI-Public: (01)07325710010617(11)250127
• Combination Product (Y/N): N
• Initial Reporter Country: TC
• 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,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/18/2025

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: 6888520
• 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: 11/07/2025
• Supplement Date Received by Manufacturer: 01/26/2026
• Initial Report FDA Received Date: 11/18/2025
• Supplement Report FDA Received Date: 01/27/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/27/2025
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown