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	Low Oxygen Saturation (2477)
Date of Event	01/22/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the anesthesia system stopped working during ongoing induction.It was not possible to ventilate the patient either in manual or automatic ventilation mode.The patient's measured saturation level decreased to 50 %.The patient was disconnected from the system and manually ventilated with a revivator and the patient saturation level became normalized.The final patient outcome was no injury.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.The system was investigated by the hospital biomedical department.No fault was found and no parts were replaced.The system device logs were saved and sent for evaluation.The system has been returned for clinical use and no further issues have been reported.The evaluation of the received system logs shows that a successful system checkout was performed prior to and after the event.The technical log has no recordings during this date, which indicate the absence of technical malfunctions in the system.The treatment began and continued for approximately six minutes until the emergency ventilation was activated.The evaluation of the log confirms the described event.The treatment was started in manual ventilation mode and then set to automatic ventilation in pressure control with low pressure settings.Alarms for expiratory minute volume low were generated.The system was thereafter switched to manual ventilation and after one-and-a-half-minute set to automatic ventilation again.Alarms for expiratory minute volume low and leakage were generated.The system was set to manual ventilation and then shutdown (emergency ventilation activated).Our conclusion, based on the performed investigation by the hospital biomedical engineer and evaluation of the logs, is that there were no technical malfunctions in the system at the time of the event.The root cause of the reported event has not been determined in this investigation.

• 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: 21393896
• Report Number: 3013876692-2025-00010
• Device Sequence Number: 8292576
• Product Code: BSZ
• UDI-Device Identifier: 07325710010624
• UDI-Public: (01)07325710010624(11)210209
• Combination Product (Y/N): N
• Initial Reporter Country: SW
• PMA/510(K) Number: K191027
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Importer
• Report Source: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date (Section B): 04/25/2025
• Report Date (Section F): 04/25/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• 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?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 04/17/2025
• Device Age: 4 YR
• Event Location: Hospital
• Date Report to Manufacturer: 04/25/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 04/17/2025
• Initial Report FDA Received Date: 02/18/2025
• Supplement Report FDA Received Date: 04/25/2025
• 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
• Outcome Attributed to Adverse Event: Life Threatening
• Patient Sex: Unknown
• Date Report Sent to FDA: 04/25/2025