MAUDE Adverse Event Report: MAQUET CRITICAL CARE AB FLOW-I C20; GAS-MACHINE, ANESTHESIA

Model Number	6677200
Medical Device Problem Code	Output Problem (3005)
Health Effect - Clinical Code	Low Oxygen Saturation (2477)
Date of Event	06/16/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the anesthesia system exhibited a continuous decline in saturation levels during use.The exact saturation values were not specified.There was no harm to the patient, and the final 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 anesthesia system was investigated on site by our field service engineer.The investigation was completed without any issues found.No technical errors found, and no parts were replaced.The system device logs were saved and sent for evaluation.The additional information received from the user facility stated that the measured patient saturation level decrease to approximately 75%.There was no patient injury.The patient was removed from the system and the ventilation continued via an ambu bag and then the mechanical ventilation continued using another system.The evaluation of the received device logs shows that the system checkout was successfully performed prior to the event.There are no recordings of a technical error which indicate the absence of technical malfunctions in the system.The log shows that the treatment was started in manual ventilation and after a few minutes set to automatic ventilation in prvc (pressure regulated volume control).The airway pressure alarm limit was set to 30 mbar.Alarms for expiratory minute volume low, respiratory rate high, airway pressure high, etco2 low and regulation pressure limited, were generated in automatic ventilation.The system was switched between manual and automatic ventilation several times and the o2 flush button was also pushed several times.Every time the system was set to automatic ventilation, the above alarms were generated.The treatment was ongoing for 23 minutes and then ended and the system was set to standby.The evaluation of the logs indicates that the generated alarms in automatic ventilation in prvc may have been caused by a too tight set airway pressure upper alarm limit in comparison to the set parameters.There is no indication of a technical failure in the system.Our conclusion is that there was no technical malfunction in the anesthesia system at the time of the event.A correction of field #h4 manufacturer date was required.H4 ¿ manufacture date - previous manufacturing date: 12/13/2016, corrected manufacturing date: 11/16/16.

• Brand Name: FLOW-I C20
• 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: 22382220
• Report Number: 3013876692-2025-00053
• Device Sequence Number: 12864653
• Product Code: BSZ
• UDI-Device Identifier: 07325710001349
• UDI-Public: (01)07325710001349(11)161116
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K191027
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Importer
• Report Source: Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/26/2025
• Report Date (Section F): 09/26/2025

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: 6677200
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 09/26/2025
• Device Age: 9 YR
• Event Location: Hospital
• Date Report to Manufacturer: 09/26/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 09/26/2025
• Initial Report FDA Received Date: 07/02/2025
• Supplement Report FDA Received Date: 09/26/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/16/2016
• 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: 09/26/2025