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

Model Number	6888530
Medical Device Problem Code	Output Problem (3005)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/05/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the anesthesia system failed in the system checkout.There was no patient involvement.Manufacturer's reference #: (b)(4).
Additional Manufacturer Narrative
The anesthesia machine was investigated onsite by our field service engineer (fse).The air gas module was found to be defective and the fse resolved the reported failure by replacing it.The anesthesia machine passed all functional and safety test and was cleared for clinical use after that.The reported failure can be confirmed in the provided logs.The logs show that the flow transducer test failed due to that there was a deviation in between delivered and measured flow from the air gas module.The logs indicates that the air gas module delivered a too high flow.The air, o2 and n2o fresh gas modules regulate the inspiratory gas flow and gas mixture.A faulty air gas module may lead to a deviation in the gas mixture and the flow and pressure may also deviate from the set or expected.This will be detected during system checkout and alarms will be activated if the failure occurs during treatment.The faulty air gas module was sent for further investigation.Then an over 48-hour, long term testing with a test were performed without any issue.Several successful system checkouts were done before and after.Our conclusion is that the reported failure was caused by the replaced air gas module but without having been able to reproduce the reported issue, we could not determine the root-cause of the reported system checkout failure.
Event or Problem Description
Manufactures reference id: (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: 20732252
• Report Number: 8010042-2024-0001908
• Device Sequence Number: 20931447
• Product Code: BSZ
• UDI-Device Identifier: 07325710010624
• UDI-Public: (01)07325710010624(11)240321
• Combination Product (Y/N): N
• Initial Reporter Country: DA
• 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): 11/20/2024

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: 6888530
• Device Catalogue Number: 6888530
• 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: 11/05/2024
• Supplement Date Received by Manufacturer: 02/18/2025
• Initial Report FDA Received Date: 11/20/2024
• Supplement Report FDA Received Date: 02/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/21/2024
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown