MAUDE Adverse Event Report: Drägerwerk AG & Co. KGaA Atlan A350; Anesthesia Units

Model Number	8621500
Medical Device Problem Codes	No Device Output (1435); Failure to Deliver (2338)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/23/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the anesthesia machine malfunctioned during operation.The monitor became inoperable (black screen) and ventilation failed.The patient could be ventilated without difficulty using a manual resuscitation bag.No patient injury reported.
Additional Manufacturer Narrative
The investigation was done on the provided information only.During on-site inspection the main circuit board m48.1 and the microsd card were identified to be faulty and were replaced.In the case of a faulty processor board, the device issues an alarm and stops automatic ventilation.In this state, the procedure can be continued by manually ventilating the patient via the manual ventilation bag.Spontaneous breathing is also possible.After replacement of the m48.1 board and the microsd card the device was tested and confirmed to be operating per manufacturer's specification.The number of similar cases, related to the same root cause, is within the expected range of the respective risk assessment and thus accepted.The field failure rate is subject to permanent monitoring by the responsible product quality board and is rated as acceptable.

• Brand Name: Atlan A350
• 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 ; +49(451)8822868
• MDR Report Key: 25841824
• Report Number: 9611500-2026-00374
• Device Sequence Number: 10382767
• Product Code: BSZ
• UDI-Device Identifier: 04048675556176
• UDI-Public: (01)04048675556176(11)251023(93)8621500-22
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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): 09/25/2026

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: 8621500
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/01/2026
• Supplement Date Received by Manufacturer: 09/22/2026
• Initial Report FDA Received Date: 07/16/2026
• Supplement Report FDA Received Date: 09/25/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/23/2025
• 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
• Patient Sex: Unknown