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

Model Number	6888520
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/01/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The investigation of this complaint has been completed.The system was investigated on-site by our field service engineer.It was confirmed that one of the two vaporizer connection seals in slot two had fallen off.A new vaporizer connection seal was mounted in the vaporizer slot two.The system was thereafter successfully tested including locking and unlocking of the vaporizer several times.The system was released for clinical use.The evaluation of the received device logs shows that all the system checkouts and leakage tests covered by the test logs have been successfully performed.At the last startup of the system no system checkout or leakage test was performed.Our conclusion is that the vaporizer connection seal had fallen off, but the cause of why the vaporizer connection seal fell off has not been possible to determine in this investigation.
Event or Problem Description
Manufacturer's reference #: (b)(4).
Event or Problem Description
It was reported that one of the vaporizer connection seal on the anesthesia system fell of during the daily routine check.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: 22540040
• Report Number: 8010042-2025-0001126
• Device Sequence Number: 8028727
• Product Code: BSZ
• UDI-Device Identifier: 07325710010617
• UDI-Public: (01)07325710010617(11)241121
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• 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: 6888520
• 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: 07/01/2025
• Supplement Date Received by Manufacturer: 10/08/2025
• Initial Report FDA Received Date: 07/18/2025
• Supplement Report FDA Received Date: 10/09/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/21/2024
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown