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

Model Number	6887700
Medical Device Problem Code	Output Problem (3005)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/10/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the anesthesia system failed during system checkout due to leakage.There was no patient involvement.Manufacturer's reference #: (b)(4).
Additional Manufacturer Narrative
The investigation of the reported failure in this complaint has been completed.A complete set of device logs was received.Evaluation of the logs shows that the system checkout (sco) failed prior to the event date.The distributor replaced parts such as the patient cassette and co2 reusable absorber.However, the issue persisted.The matter was escalated to the support technician team.Given the multiple failures, it was recommended to localize the leakage using the pump tool and, if unresolved, to replace the air gas module followed by the fresh gas module, one at a time.After thorough troubleshooting, the distributor determined that the leakage was caused by the volume reflector and that a new part would be required.The customer declined the quotation for replacement, and the system remains out of service.
Event or Problem Description
Manufacturer's reference #: (b)(4).

• Brand Name: FLOW-C 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: 21332315
• Report Number: 8010042-2025-0000210
• Device Sequence Number: 7918233
• Product Code: BSZ
• UDI-Device Identifier: 07325710009765
• UDI-Public: (01)07325710009765(11)200812
• Combination Product (Y/N): N
• Initial Reporter Country: BL
• PMA/510(K) Number: K191027
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/07/2025

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: 6887700
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/10/2025
• Supplement Date Received by Manufacturer: 08/11/2025
• Initial Report FDA Received Date: 02/07/2025
• Supplement Report FDA Received Date: 08/11/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/12/2020
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown