MAUDE Adverse Event Report: DRÄGERWERK AG & CO. KGAA ATLAN A350 XL; ANESTHESIA UNITS

Model Number	8421600
Medical Device Problem Codes	Decrease in Pressure (1490); Inaccurate Delivery (2339); Gas/Air Leak (2946)
Health Effect - Clinical Code	Respiratory Failure (2484)
Date of Event	03/18/2026
Type of Reportable Event	Death
Additional Manufacturer Narrative
The device log was analyzed for the reported date of event march 18th 2026.No indications of a device malfunction were found.This was also confirmed during on-site inspection after the event as the device was tested and confirmed to be operating per manufacturer¿s specification.The case in question was the third procedure of the day.It was started at 15:28 and ended at 16:15.It was found that during the case the device alarmed for "fresh gas low or leakage" indicating that leakages were present.Before the procedure in question the device successfully passed the leakage test.After the procedure, a leak and system test was successfully completed.Based on these facts, a device failure being root cause for the leakage can be excluded.It was comprehensible based on the records that external leakages e.G.In the breathing circuit were present during the procedure.The device responded to the situation as specified by posting corresponding alarms to inform the user.
Event or Problem Description
It was reported that the patient expired during surgery.There is no alleged device malfunction or issues with the machine's performance reported.

• Brand Name: ATLAN A350 XL
• Common Device Name: ANESTHESIA UNITS
• Manufacturer (Section D): DRÄGERWERK AG & CO. KGAA; moislinger allee 53-55; lübeck ; GM
• Manufacturer (Section G): DRÄGERWERK AG & CO. KGAA; moislinger allee 53-55; lübeck 23558 ; GM 23558
• Manufacturer Contact: moislinger allee 53-55; lübeck 23558 ; 4518822868
• MDR Report Key: 24726713
• Report Number: 9611500-2026-00136
• Device Sequence Number: 10421585
• Product Code: BSZ
• UDI-Device Identifier: 04048675556183
• UDI-Public: (01)04048675556183(11)250620(93)8621600-20
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K230931
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date (Section B): 03/30/2026

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: 8421600
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/24/2026
• Initial Report FDA Received Date: 03/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/20/2025
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Death
• Patient Sex: Unknown