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

Model Number	8621500
Medical Device Problem Code	No Device Output (1435)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/14/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The investigation was just reported.The result will be forwarded once the investigation is closed.
Event or Problem Description
It was reported that the device suddenly failed during ventilation in psv-mode, screen was black.Emergency ventilation was initiated.No injury reported.
Additional Manufacturer Narrative
For the investigation the replaced m48.1 board was analysed.The m48.1 board was identified as the cause of the reported symptom.If the processor board is faulty, the device issues an alarm and stops automatic ventilation.In this case, the patient can continue to be ventilated in manual emergency mode or with an emergency manual ventilation bag.On site the device was tested after the replacement of the m48.1 board and found to be within 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 ffr is monitored in the responsible pqb, in case it is decided that measures are neccessary, this is derived from the pqb.
Event or Problem Description
It was reported that the device suddenly failed during ventilation in psv-mode, screen was black.Emergency ventilation was initiated.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 23558 ; GM 23558
• Manufacturer Contact: moislinger allee 53-55; lübeck 23558 ; 4518822868
• MDR Report Key: 24505180
• Report Number: 9611500-2026-00094
• Device Sequence Number: 21460102
• Product Code: BSZ
• UDI-Device Identifier: 04048675556176
• UDI-Public: (01)04048675556176(11)251015(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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/16/2026

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?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/19/2026
• Supplement Date Received by Manufacturer: 04/15/2026
• Initial Report FDA Received Date: 03/04/2026
• Supplement Report FDA Received Date: 04/16/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/15/2025
• 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