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	09/05/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that towards the end of closing wound, there was an unusual noise from the device and the mechanical ventilation stopped.Manual ventilation was initiated, and the operation was completed safely.No patient injury was reported.
Additional Manufacturer Narrative
The investigation was performed based on the given information (including electronic log file).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.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 capa (corrective and preventive actions) was initiated.

• Brand Name: ATLAN A350
• Common Device Name: ANESTHESIA UNITS
• Manufacturer (Section D): DRÄGERWERK AG & CO. KGAA
• Manufacturer (Section G): DRÄGERWERK AG & CO. KGAA

4518822868

• MDR Report Key: 23035223
• Report Number: 9611500-2025-00513
• Device Sequence Number: 21164509
• Product Code: BSZ
• UDI-Device Identifier: 04048675556176
• UDI-Public: (01)04048675556176(11)231221(93)8621500-15
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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): 09/12/2025

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?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/05/2025
• Initial Report FDA Received Date: 09/12/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/21/2023
• 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.
• Patient Sex: Unknown