MAUDE Adverse Event Report: MAQUET CRITICAL CARE AB FLOW-I C30; GAS-MACHINE, ANESTHESIA

Model Number	6677300
Medical Device Problem Code	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 the pressure transducer test during system checkout.There was no patient involvement.Manufacturer's reference number: (b)(4).
Additional Manufacturer Narrative
The anesthesia system was investigated onsite by our field service engineer (fse) due to a failing system check out.The inspiratory gas pressure transducer printed circuit board (pcb) was found to be defective and the fse resolved the reported failure by replacing it.The anesthesia system passed all functional and safety test and was cleared for clinical use.A set of device logs was received in which the reported failures can be confirmed.The faulty part was sent for further investigation.Visual inspection of the returned part revealed no abnormalities.The inspiratory gas pressure transducer printed circuit board was tested in our anesthesia laboratory.The reported pressure transducer test failure could be reproduced during the investigation, the zero pressure transducer offset of the inspiratory pressure transducer was measured to 0 v.In the received device logs, the measured offset was 1584 mv.A normal zero pressure offset should be around 2 v (2000 mv).The cause of the pressure transducer test failure was an imbalanced pressure sensor.The true cause why the pressure sensor was imbalanced has not been determined.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.
Event or Problem Description
Manufacturer's reference id: (b)(4).

• Brand Name: FLOW-I C30
• 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: 20784626
• Report Number: 8010042-2024-0001941
• Device Sequence Number: 14703487
• Product Code: BSZ
• UDI-Device Identifier: 07325710001363
• UDI-Public: (01)07325710001363(11)161007
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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): 11/26/2024

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: 6677300
• 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: 11/12/2024
• Supplement Date Received by Manufacturer: 03/20/2025
• Initial Report FDA Received Date: 11/26/2024
• Supplement Report FDA Received Date: 03/20/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/07/2016
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown