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

Model Number	8621500
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	09/06/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The investigation is still on-going.The results will be provided with a follow-up report.
Event or Problem Description
It was reported that after approximately 30 minutes of ventilation, the device displayed ventilator failure and emergency intake.It was switched to standby mode and after a while it started working again and continued to be used.
Additional Manufacturer Narrative
The user reported that the ventilator failure occurred during suctioning of the tube.According to the log records, it was possible to trace that repeated suctioning of the tube during volume-controlled ventilation which resulted in multiple negative pressures and peep drops.After briefly switching to standby mode and then returning to vc-af, the ventilator failure occurred after approximately four seconds.It was not possible to reproduce the failure in the laboratory by repeatedly suctioning the tube.Based on the error log entries, it was possible to determine that the ventilator failure was initiated due to implausible signals from the incremental encoder.The motor was replaced and examined accordingly.No deviations were found during the visual inspection or the tests performed.Finally, it was not possible to determine the exact cause of the ventilator failure.It can be assumed that a sporadic error in the incremental encoder was the cause.A ventilator failure is indicated by the device with the highest alarm priority, both acoustically and visually.Manual ventilation via the manual resuscitation bag and spontaneous breathing are still possible.The user is prompted on the screen to confirm the change in therapy.Fresh gas dosing and anesthetic dosing via connected vaporizers are still possible; monitoring also remains available.The risk to devices in the field is accepted.
Event or Problem Description
It was reported that after approximately 30 minutes of ventilation, the device displayed ventilator failure and emergency intake.It was switched to standby mode and after a while it started working again and continued to be used.

• 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 ; 4518822868
• MDR Report Key: 23107512
• Report Number: 9611500-2025-00532
• Device Sequence Number: 15870248
• Product Code: BSZ
• UDI-Device Identifier: 04048675556176
• UDI-Public: (01)04048675556176(11)230330(93)8621500-15
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• 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: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/13/2025

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: 8621500
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 09/09/2025
• Supplement Date Received by Manufacturer: 11/07/2025
• Initial Report FDA Received Date: 09/22/2025
• Supplement Report FDA Received Date: 11/13/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/30/2023
• 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