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

Model Number	6887700
Medical Device Problem Code	Failure of Device to Self-Test (2937)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/31/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the anesthesia system failed pressure transducer test during system checkout.There was no patient involvements.Manufacturer's reference #: (b)(4).
Event or Problem Description
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) investigated the system on-site and confirmed the issue.The fse replaced the pressure transducer pcb which resolved the issue.Following the replacement, the system was returned to normal operation.The replaced part is not available, preventing further analysis.A complete set of device logs was received.Evaluation of the logs shows that system checkout failed the safety valve and pressure transducer tests.The measured zero pressure offset for the inspiratory pressure transducer pcb was outside the test range, measured zero pressure offset values were between [2498 - 2582 mv].The technical log contains a technical error code indicting safety valve open, which is likely to have been caused by the faulty pressure transducer.The pressure transducer pcb has a factory calibrated zero pressure offset value that normally is 2 ± 0.5 v.During system checkout a high pressure offset value is measured and if the measured value is outside the allowed limit (±300mv from factory calibrated value) the test will fail.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 if present, 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 replacement of the pressure transducer pcb solved the reported issue.

• 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: 23552124
• Report Number: 8010042-2025-0001655
• Device Sequence Number: 18524297
• Product Code: BSZ
• UDI-Device Identifier: 07325710009765
• UDI-Public: (01)07325710009765(11)220802
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• PMA/510(K) Number: K191027
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (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): 11/14/2025

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: 10/31/2025
• Supplement Date Received by Manufacturer: 11/19/2025
• Initial Report FDA Received Date: 11/14/2025
• Supplement Report FDA Received Date: 11/19/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/02/2022
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown