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

Model Number	8621600
Medical Device Problem Codes	Gas Output Problem (1266); Failure to Analyze Signal (1539); Failure to Deliver (2338)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/08/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The investigation was performed based on the given information including the electronic log file.Initially the logfile analysis did not reveal a technical failure for the reported dates of event ((b)(6), 2024).However, the reported issue could be confirmed for (b)(6) 2024.It was determined that a failure of the optical incremental encoder was the root cause.The device detected the failure and reacted as specified for this situation.In case of such failure, atlan will still provide fresh gas (including agent if a vaporizer is connected) and monitoring allowing for manual ventilation.Based on the currently available information, the risk related to the specific situation has been initially evaluated.Since similar complaints have been reported recently, a capa (corrective and preventive actions for products) was initiated.The risk assessment within the capa determined that the risk is increased and that mitigation measures are necessary.A field safety corrective action has just been released.
Event or Problem Description
It was reported that the device stopped ventilating the patient during a surgical intervention in two occasions.One on (b)(6) 2024 and one on (b)(6) 2024.No injury was 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: 21545065
• Report Number: 9611500-2025-00107
• Device Sequence Number: 7134488
• Product Code: BSZ
• UDI-Device Identifier: 04048675556183
• UDI-Public: (01)04048675556183(11)200429(93)8621600-08
• 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
• Report Date (Section B): 03/07/2025

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: 11/19/2024
• Initial Report FDA Received Date: 03/07/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/29/2020
• 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.
• Patient Sex: Unknown