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

Model Number	6887900
Medical Device Problem Code	Use of Incorrect Control/Treatment Settings (1126)
Health Effect - Clinical Code	Low Oxygen Saturation (2477)
Date of Event	04/29/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Our initial evaluation of the device logs shows that the reported drop in fio2 was related to parameter settings at the time of the event.The log shows that the fresh gas flow was set to 1 l/minute and the oxygen concentration to 40 %.The delivered minute volume to the patient was approximately 5 l/minute at the time.Fio2 is dependent on a combination of set fresh gas flow and set oxygen concentration, however it is also relative to the minute volume delivered to the patient.The settings at the time of the event leads to a high degree of re-breathing.With these settings applied and in relation to the size of the patient and delivered minute volume, rebreathed gas will over time contain less oxygen since the patient is consuming the oxygen as part of his/hers metabolism.No fault with the system has been found.
Event or Problem Description
It was reported that during patient treatment, the anesthesia system was not working properly and the fio2 dropped rapidly.There was also a drop in the patient's saturation level.The user switched to the built-in emergency ventilation which resolved the issue.Final patient outcome was no injury.Manufacturer's reference number: (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: 25296329
• Report Number: 8010042-2026-0000694
• Device Sequence Number: 21144520
• Product Code: BSZ
• UDI-Device Identifier: 07325710010457
• UDI-Public: (01)07325710010457(11)240216
• 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
• Report Date (Section B): 05/27/2026

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?: No
• 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: 04/29/2026
• Initial Report FDA Received Date: 05/27/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/16/2024
• 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 Age: 18 YR
• Patient Sex: Unknown
• Patient Weight: 50 KG