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

Model Number	6888520
Medical Device Problem Code	Failure to Deliver (2338)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/18/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The investigation of this complaint has been completed.The system was investigated by the hospital personnel and our field service engineer.No fault was found, and no parts were replaced.The system device logs were received for evaluation.According to the received information from the customer, the breathing circuit used at the time of the event was tested in the system checkout after the event.The evaluation of the received system device logs shows that the system checkouts performed before the event and after the event were successful.The logs show that two treatment periods are recorded before the given time of the event.No new system checkout and leakage tests were performed between these treatment periods.This means that the new breathing circuit connected to the system was not checked for leakage before the patient treatment was started.The technical log has no recordings on this date which indicate the absence of technical malfunctions in the system.The log shows that around the given time of the event, six short treatment periods were started.During these treatment periods, the ventilation mode was alternated between manual and automatic ventilation in all treatments periods.Our conclusion is that there was some kind of leakage during the treatment.However, the system checkouts both before and after the treatment were successful and there is no technical error recorded which indicate the absence of technical malfunctions in the system.The root cause of the reported event could not be determined in this investigation.According to the user's manual, it is recommended to perform a system checkout or leakage check when a new breathing system is connected.
Event or Problem Description
It was reported that during the procedure, the automatic ventilation parameters suddenly disappeared, and no values were displayed on the interface.The end user immediately attempted to switch to manual ventilation mode, but manual ventilation was also non-functional.There was no patient harm.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: 23014524
• Report Number: 8010042-2025-0001392
• Device Sequence Number: 13146441
• Product Code: BSZ
• UDI-Device Identifier: 07325710010617
• UDI-Public: (01)07325710010617(11)230113
• Combination Product (Y/N): N
• Initial Reporter Country: TC
• 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): 09/10/2025

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: 08/20/2025
• Initial Report FDA Received Date: 09/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/13/2023
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown