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

Model Number	6677200
Medical Device Problem Code	Output Problem (3005)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/17/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the anesthesia system generated a technical error code indicating safety valve open.The system checkout also failed in the pressure transducer test.There was no patient involvement.Manufacturer's reference #: (b)(4).
Additional Manufacturer Narrative
The investigation of this complaint has been completed.The system was investigated by our field service engineer and the reported fault was reproduced.The field service engineer found that the inspiratory pressure transducer pcb was faulty, and it was replaced.The system was thereafter working normally.The replaced part was returned for investigation.The evaluation of the received system device logs confirms the reported.The system checkout failed the pressure transducer test due to the measured zero pressure offset for the inspiratory pressure transducer pcb being out of range; the measured zero pressure offset was 6.2 v.The pressure transducer pcb has a factory calibrated zero pressure offset value that normally is 2 ± 0.5 v.During system checkout the zero-pressure offset value is measured and if the measured value is outside the allowed limit (±300 mv from factory calibrated value) the test will fail.The returned pressure transducer pcb was simulating use tested.Several system checkouts were successfully performed and ventilation tests ongoing for a longer period was performed without any deviations.The reported failure could not be reproduced during the investigation of the returned pressure transducer pcb.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 there may be an intermittent fault with the pressure transducer pcb and that the returned pressure transducer pcb was the cause of the reported failure.
Event or Problem Description
Manufacturer's reference #: (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: 22540112
• Report Number: 8010042-2025-0001127
• Device Sequence Number: 7410618
• Product Code: BSZ
• UDI-Device Identifier: 07325710001349
• UDI-Public: (01)07325710001349(11)170117
• Combination Product (Y/N): N
• Initial Reporter Country: FI
• 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): 07/18/2025

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: 6677200
• 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: 07/17/2025
• Supplement Date Received by Manufacturer: 10/16/2025
• Initial Report FDA Received Date: 07/18/2025
• Supplement Report FDA Received Date: 10/16/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/17/2017
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown