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

Model Number	6887900
Medical Device Problem Code	Output Problem (3005)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/26/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the anesthetic agent delivery was delayed during treatment.It started to deliver after the agent concentration was increased.There was no patient harm.Manufacturer's reference #: (b)(4).
Additional Manufacturer Narrative
The investigation of this complaint has been completed.The vaporizer used at the time of the event was removed after the treatment had ended.The vaporizer was returned for investigation, and the system device logs were received for evaluation.The evaluation of the system logs can confirm the reported event.The log shows that inspired and expired agent concentration started to be measured only after the set agent concentration had been increased by the user.The returned vaporizer was subjected to simulated use testing in an anesthesia system under various conditions.Different agent concentrations were tested, and the measured output matched the set concentrations, confirming correct delivery performance.The vaporizer was also tested in the vaporizer test system, where a calibration was performed without finding any deviations.Dosage accuracy was verified, and the liquid level sensor was confirmed to function correctly, showing accurate agent levels.The vaporizer software includes several alarms to detect agent delivery failures.To confirm alarm functionality, simulated use testing was performed with multiple software versions, including the version that was installed in the vaporizer during the event.The alarms were activated correctly in all cases.The conclusion of the investigation is that no faults were found in the vaporizer hardware, sensors, or alarm mechanisms.The reported delay in agent delivery was not reproduced under controlled conditions.The exact root cause has not been determined.
Event or Problem Description
Manufacturer's reference #: (b)(4).

• Brand Name: FLOW-E 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: 23376740
• Report Number: 8010042-2025-0001574
• Device Sequence Number: 8965258
• Product Code: BSZ
• UDI-Device Identifier: 07325710010457
• UDI-Public: (01)07325710010457(11)240207
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K191027
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/24/2025

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: 6887900
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/26/2025
• Supplement Date Received by Manufacturer: 03/17/2026
• Initial Report FDA Received Date: 10/24/2025
• Supplement Report FDA Received Date: 03/17/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/07/2024
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown