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

Model Number	8621600
Medical Device Problem Codes	Incorrect Interpretation of Signal (1543); Use of Device Problem (1670); Failure to Deliver (2338)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/15/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a ventilator failure occurred during use.No injury reported.
Additional Manufacturer Narrative
The investigation is still on-going.The results will be provided with a follow-up report.
Additional Manufacturer Narrative
Based on the logfile analysis, the case in question could be reconstructed.The device detected a high pressure difference between the inspiratory and expiratory pressure during inspiration.In this phase the pressure in the ventilator, the inspiratory branch and the expiratory branch up to the closed peep/pmax valve should be nearly identical.In case of a significant deviation of the pressure values the atlan issues a "ventilator failure" alarm and stops automatic ventilation as a safety function to prevent from wrong airway pressure and switches to man/spont ventilation.The detected pressure deviation was caused by a high resistance between inspiratory and expiratory branch.This can be caused by a stenosis or a wet filter.A technical device failure was not found.Finally, it can be concluded that the atlan has responded to the detected deviation as specified and has stopped the automatic ventilation accompanied by a corresponding "vent fail" alarm.
Event or Problem Description
It was reported that a ventilator failure occurred during use.No injury 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 23542 ; GM 23542
• Manufacturer Contact: moislinger allee 53-55; lübeck 23542 ; 4518822868
• MDR Report Key: 21415089
• Report Number: 9611500-2025-00082
• Device Sequence Number: 9199150
• Product Code: BSZ
• UDI-Device Identifier: 04048675556183
• UDI-Public: (01)04048675556183(11)230414(93)8621600-15
• Combination Product (Y/N): N
• PMA/510(K) Number: K230931
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date (Section B): 07/08/2025

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: 8621600
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/23/2025
• Supplement Date Received by Manufacturer: 06/30/2025
• Initial Report FDA Received Date: 02/19/2025
• Supplement Report FDA Received Date: 07/08/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/14/2023
• 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
• Concomitant Medical Products and Therapy/Usage Dates: NA.; NA.
• Patient Sex: Unknown