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

Model Number	6888520
Medical Device Problem Code	Output Problem (3005)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/06/2025
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 not reproduced.The inspiratory pressure transducer pcb and the expiratory channel pcb were replaced as a precaution according to recommended action in the service manual for this fault.No further issues have been reported.The replaced parts were retained by the customer and was not returned for investigation.The device logs were received for evaluation.The evaluation of the logs can confirm the reported technical error code indicating that the safety valve was open when it was supposed to be closed, on several occasions.The logs confirm that all technical error codes have occurred when the system was in standby mode.The log also shows that during the last treatment period, started after a successful system checkout, several alarms indicating a high airway pressure situation were generated.The system checkout performed after was successful.It is unknown if these alarms were due to that the parameter settings and alarm limits were to narrow or if these alarms are related to a fault with the replaced parts.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 inspiratory pressure via the inspiratory pressure transducer pcb, and the safety valve functions.An incorrect control of the safety valve function may lead to stop of ventilation.Faults on these pcb: s will be detected during system checkout if present and high priority alarms will be generated if the failure occurs during treatment.Our conclusion is that the replaced parts are the parts that may be involved in the reported event.The exact root cause of the reported event has not been determined since the parts were not returned.
Event or Problem Description
It was reported that the anesthesia system generated a technical error code indicating safety valve open.There was no patient involvement.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: 23726476
• Report Number: 8010042-2025-0001775
• Device Sequence Number: 18798855
• Product Code: BSZ
• UDI-Device Identifier: 07325710010617
• UDI-Public: (01)07325710010617(11)210910
• 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): 12/05/2025

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
• Device Catalogue Number: 6888520
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/06/2025
• Initial Report FDA Received Date: 12/05/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/10/2021
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown