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

Model Number	6888520
Medical Device Problem Codes	Electrical /Electronic Property Problem (1198); Output Problem (3005)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/30/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the anesthesia system failed the pressure transducer test during system checkout.There was no patient involvement.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 investigated the anesthesia system at the hospital.The investigation concluded that the inspiratory pressure transducer was faulty and needed to be replaced.After replacement of the faulty part and successfully testing, the anesthesia system was cleared for clinical use.The replaced part was scrapped which prevents further technical investigations.A complete set of device logs has been received and the test log shows that the inspiratory pressure transducer's gain correction factor was outside its allowed limits on several occasions.Without having been able to investigate the replaced part, we have not been able to draw any conclusion about the true cause of the reported system checkout failure apart from the issue having been caused by the faulty inspiratory pressure transducer.
Event or Problem Description
Manufacturer's reference number: (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: 22824742
• Report Number: 8010042-2025-0001265
• Device Sequence Number: 11900544
• Product Code: BSZ
• UDI-Device Identifier: 07325710010617
• UDI-Public: (01)07325710010617(11)211112
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• 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): 08/18/2025

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?: 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: 09/29/2025
• Initial Report FDA Received Date: 08/18/2025
• Supplement Report FDA Received Date: 09/30/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/12/2021
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown