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

Model Number	6888530
Medical Device Problem Code	Output Problem (3005)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/18/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during patient treatment, the anesthesia system was unable to maintain the set peep level.There was no patient harm.Manufacturer's reference number: (b)(4).
Event or Problem Description
Manufacturer's reference number: (b)(4).
Additional Manufacturer Narrative
The investigation of the reported failure in this complaint has been completed.Our field service engineer (fse) investigated the system on site and found the inspiratory pressure transducer pcb was defective and require replacement.Following the replacement of the pcb, the issue was resolved, and the anesthesia system was cleared for clinical use.The replaced part was not returned.Therefore, no further analysis or technical investigation could be made.A complete set of device logs was received.Evaluation of the logs shows that before and on the event, a successful system checkout was performed.The obtained trend log did not cover the event the technical log has no recordings during this date which indicate the absence of technical malfunctions in the system.The fse was unable to confirm when the customer experienced the issue or when the error was reported.Although the event date was stated as june 18th, records indicate that the system had not been used on that day.Alarms for high peep were present on june 11th and 16th, while alarms for low peep were triggered on june 13th.Our conclusion, based on the fse findings and device log evaluation, is that the inspiratory pressure transducer pcb was the cause of the reported failure.

• 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: 22392605
• Report Number: 8010042-2025-0001014
• Device Sequence Number: 13017874
• Product Code: BSZ
• UDI-Device Identifier: 07325710010624
• UDI-Public: (01)07325710010624(11)221121
• Combination Product (Y/N): N
• Initial Reporter Country: DA
• PMA/510(K) Number: K191027
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (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): 07/01/2025

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: 6888530
• 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: 06/18/2025
• Supplement Date Received by Manufacturer: 09/10/2025
• Initial Report FDA Received Date: 07/03/2025
• Supplement Report FDA Received Date: 09/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/21/2022
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown