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	09/17/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The investigation of this complaint has been completed.Our field service engineer investigated the system on site.The reported failure was reproduced and it was solved by replacing the expiratory channel pcb and the inspiratory pressure transducer pcb.The software was installed again after the replacement of the pcb.The parts were kept by the customer and not returned.The device logs were received for evaluation.The evaluation of the logs shows that the system checkout was successfully performed after the event and the reported technical error was not reproduced.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.The expiratory channel pcb contains electronics including among others, microprocessor for handling of the measurement of fresh gas pressure and inspiratory pressure via the fresh gas pressure transducer pcb and inspiratory pressure transducer pcb, and the safety valve functions.The expiratory channel pcb contains holders and electrical connectors for the inspiratory and fresh gas pressure transducer pcbs.Incorrect control of the safety valve function may lead to stop of ventilation.Faults on these pcbs will be detected during system checkout and high priority alarms will be generated if the failure occurs during treatment.Our conclusion, based on the investigation performed by our field service engineer, is that the replaced parts were the cause of the reported event.
Event or Problem Description
It was reported that the anesthesia system generated a technical error code indicating that the safety valve was open.There was no patient involvement.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: 23276721
• Report Number: 8010042-2025-0001526
• Device Sequence Number: 12139216
• Product Code: BSZ
• UDI-Device Identifier: 07325710001349
• UDI-Public: (01)07325710001349(11)181126
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• 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
• Report Date (Section B): 10/13/2025

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
• Device Catalogue Number: 6677200
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/17/2025
• Initial Report FDA Received Date: 10/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/26/2018
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown