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

Model Number	6887700
Medical Device Problem Codes	Failure of Device to Self-Test (2937); Output Problem (3005)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/29/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the pressure transducer test failed during system checkout.There was no patient involvement.Manufacturer's reference number: (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: 22684249
• Report Number: 8010042-2025-0001200
• Device Sequence Number: 9473153
• Product Code: BSZ
• UDI-Device Identifier: 07325710009765
• UDI-Public: (01)07325710009765(11)250116
• Combination Product (Y/N): N
• Initial Reporter Country: VM
• PMA/510(K) Number: K191027
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Y
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/01/2025

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: 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: 07/30/2025
• Supplement Date Received by Manufacturer: 05/28/2026
• Initial Report FDA Received Date: 08/01/2025
• Supplement Report FDA Received Date: 05/29/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/16/2025
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown