MAUDE Adverse Event Report: MAQUET CRITICAL CARE AB FLOW-I C30 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	07/31/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a technical error code indicating an open safety valve was generated.There was no patient involvement.Manufacturer's reference number: (b)(4).
Event or Problem Description
Manufacturer's reference number: (b)(4).
Additional Manufacturer Narrative
The investigation of this complaint has been completed.Our field service engineer (fse) conducted an on-site investigation and replaced the inspiratory pressure transducer pcb which resolved the issue.Following the replacement, the unit was returned to clinical use.The pressure transducer pcb was returned for investigation and the system device logs were received for evaluation.The evaluation of the logs shows that a technical error code indicating an airway pressure sensor error occurred during treatment, followed by the triggering of the technical error code indicating an open safety valve approximately seven minutes later.The treatment was subsequently stopped, and the system checkout performed failed.Thereafter, technical error code indicating an open safety valve was displayed immediately after several startup attempts.The returned inspiratory pressure transducer pcb was simulate-use tested in a reference anesthesia system.Immediately after power-up, the technical error code indicating an open safety valve was triggered, resulting in a failure of the system checkout.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 is that the pressure sensor on the inspiratory pressure transducer pcb was the cause of the reported failure.

• Brand Name: FLOW-I C30 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: 22711043
• Report Number: 8010042-2025-0001213
• Device Sequence Number: 21115207
• Product Code: BSZ
• UDI-Device Identifier: 07325710010624
• UDI-Public: (01)07325710010624(11)230217
• Combination Product (Y/N): N
• Initial Reporter Country: FI
• 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): 08/05/2025

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: 6888530
• 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: 07/31/2025
• Supplement Date Received by Manufacturer: 10/28/2025
• Initial Report FDA Received Date: 08/05/2025
• Supplement Report FDA Received Date: 10/28/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/17/2023
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown