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	06/27/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the pressure transducer test failed during the system checkout.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.Our field service engineer (fse) conducted an on-site investigation and replaced the inspiratory pressure transducer pcb and resolved the issue.Following the replacement, the unit was returned to clinical use.The replaced part was not returned, preventing further analysis.A complete set of device logs was received.Evaluation of the logs shows that prior to and on the event day, system checkouts were performed and didn't pass.The test log shows that the inspiratory pressure transducer gain correction factors were out of range.The pressure transducer pcb is part of the pressure measuring in the system.A faulty pressure transducer pcb may lead to inaccuracy in pressure measurement.This will be detected during system checkout and high priority alarms will be generated if the failure occurs during treatment.Our conclusion, based on the fse finding and device log evaluation, is that the inspiratory pressure transducer pcb was the cause of the reported failure and the measures taken solved the reported issue.
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: 22540158
• Report Number: 8010042-2025-0001102
• Device Sequence Number: 15436905
• Product Code: BSZ
• UDI-Device Identifier: 07325710009765
• UDI-Public: (01)07325710009765(11)210209
• Combination Product (Y/N): N
• Initial Reporter Country: PL
• 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): 07/16/2025

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?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/11/2025
• Supplement Date Received by Manufacturer: 09/15/2025
• Initial Report FDA Received Date: 07/18/2025
• Supplement Report FDA Received Date: 09/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/09/2021
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown