MAUDE Adverse Event Report: MAQUET CRITICAL CARE AB FLOW-I C40; GAS-MACHINE, ANESTHESIA

Model Number	6677400
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)
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the anesthesia system failed during the system checkout test.According to the received system device logs, two technical error codes indicating airway pressure sensor error had been generated.There was no patient involvement.Manufacturer's reference #: (b)(4).
Event or Problem Description
Manufacturer's reference # (b)(4).
Additional Manufacturer Narrative
The investigation of this complaint has been completed.Our field service engineer investigated the system on site and confirmed the reported failure.The anesthesia system was returned for further investigation.The evaluation of the received log shows that the system checkout had failed in the pressure transducer test on two occasions.The test failed due to the measured zero pressure offset for the expiratory pressure transducer pcb being out of range; the measured zero pressure offset was 2 mv.The pressure transducer pcb has a factory calibrated zero pressure offset value that normally is 2 ± 0.5 v.During system checkout the zero-pressure offset value is measured and if the measured value is outside the allowed limit (±300 mv from factory calibrated value) the test will fail.The investigation of the returned anesthesia system could not reproduce the pressure transducer test failure.The system checkout was performed several times and simulated ventilation tests on a test lung mode were successful, no technical error or other alarms were generated.Based on the evaluation of the received logs it was decided to replace the expiratory pressure transducer as a precaution.During the replacement of the expiratory pressure transducer pcb, it was noticed that the plastic clamp (locking part) holding the expiratory pressure transducer pcb was broken.Our conclusion is that the cause of the pressure transducer test failure and the technical error codes was the broken plastic clamp.The broken plastic clamp holding the pressure transducer pcb may cause a loose contact in between the expiratory pressure transducer pcb and the valve driver's pcb that holds the pressure transducer pcb.To improve the connection between the pressure transducer pcb and the pcb that holds the pressure transducer pcb the plastic clamp holding the pressure transducer pcb has been replaced with a cable tie.This has been implemented in the production line of new systems.The anesthesia system in this complaint was manufactured before the improved connection was implemented.

• Brand Name: FLOW-I C40
• 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: 22029138
• Report Number: 8010042-2025-0000771
• Device Sequence Number: 8476001
• Product Code: BSZ
• UDI-Device Identifier: 07325710001318
• UDI-Public: (01)07325710001318(11)200925
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• 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): 05/15/2025

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: 6677400
• Device Catalogue Number: 6677400
• 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: 05/12/2025
• Supplement Date Received by Manufacturer: 09/12/2025
• Initial Report FDA Received Date: 05/15/2025
• Supplement Report FDA Received Date: 09/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/25/2020
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown