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); Activation Failure (3270)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/05/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the device while connected to a patient, gave a ventilation motor failure alarm and then changed into safety mode.The surgery was concluded without any incidence with the device in manual mode.No injury reported.
Additional Manufacturer Narrative
The investigation was just started.The result will be forwarded in a follow up report.
Additional Manufacturer Narrative
The reported issue could be confirmed and 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 by alarming with "ventilator failure" with the highest alarm priority.In this state, manual ventilation via the manual ventilation bag can take place immediately (spontaneous breathing is also possible).The user is informed on the screen to confirm the change of therapy.In case of such failure, atlan will still provide fresh gas (including agent if a vaporizer is connected) and monitoring allowing for manual ventilation.Since similar complaints have been reported recently, a field action is currently in planning.On site the motor was exchanged.No further problems were described since then.
Event or Problem Description
It was reported that the device while connected to a patient, gave a ventilation motor failure alarm and then changed into safety mode.The surgery was concluded without any incidence with the device in manual mode.No injury reported.
Additional Manufacturer Narrative
The reported issue could be confirmed and 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 by alarming with "ventilator failure" with the highest alarm priority.In this state, manual ventilation via the manual ventilation bag can take place immediately (spontaneous breathing is also possible).The user is informed on the screen to confirm the change of therapy.In case of such failure, atlan will still provide fresh gas (including agent if a vaporizer is connected) and monitoring allowing for manual ventilation.Since similar complaints have been reported recently, a field action is currently in planning.On site the motor was exchanged.No further problems were described since then.Update: compared to the final report from (b)(6) 2025, the coding in this report had to be updated.
Event or Problem Description
It was reported that the device while connected to a patient, gave a ventilation motor failure alarm and then changed into safety mode.The surgery was concluded without any incidence with the device in manual mode.No injury reported.

• 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 23542 ; GM 23542
• Manufacturer Contact: moislinger allee 53-55; lübeck 23542 ; 4518822868
• MDR Report Key: 22317704
• Report Number: 9611500-2025-00326
• Device Sequence Number: 21035737
• Product Code: BSZ
• UDI-Device Identifier: 04048675556176
• UDI-Public: (01)04048675556176(11)250402(93)8621500-20
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• 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,Followup
• Report Date (Section B): 08/13/2025

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: 06/10/2025
• Supplement Date Received by Manufacturer: 07/08/2025; 07/08/2025
• Initial Report FDA Received Date: 06/24/2025
• Supplement Report FDA Received Date: 08/06/2025; 08/13/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/02/2025
• 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