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

Model Number	6677200
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	11/21/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the pressure transducer test failed during system checkout.There was no patient involvement.Manufacturer's reference number: (b)(4).
Additional Manufacturer Narrative
The investigation of the reported complaint has been completed.The anesthesia system was investigated by the field service engineer.The reported failure was reproduced.Two pressure transducer pcbs¿ were found faulty and were replaced.The returned pressure transducer pcbs were inspected visually; no damages or deviations could be noticed.After installing of the pcbs in a reference system, a system checkout was performed.All tests passed.After a few hours in ventilation mode, the system began to generate a technical error code indicating an open safety valve and there was a total stop of ventilation.A new system checkout was performed which failed multiple sub tests and the pressure transducer test failed due to the zero-pressure offset had drifted.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 into this matter is that the returned pressure transducers were faulty.
Event or Problem Description
Manufacturer's reference number: (b)(4).

• Brand Name: FLOW-I C20
• 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: 23715013
• Report Number: 8010042-2025-0001762
• Device Sequence Number: 18710966
• Product Code: BSZ
• UDI-Device Identifier: 07325710001349
• UDI-Public: (01)07325710001349(11)200817
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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): 12/04/2025

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: 6677200
• 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: 11/21/2025
• Supplement Date Received by Manufacturer: 05/06/2026
• Initial Report FDA Received Date: 12/04/2025
• Supplement Report FDA Received Date: 05/11/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/17/2020
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown