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 Deliver (2338); Protective Measures Problem (3015)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/08/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The investigation was just started.The result will be forwarded in a follow up report.
Event or Problem Description
It was reported that on (b)(6) 2025, manual ventilation was performed, followed by a switch to automatic ventilation.After approximately two minutes, the atlan a350 alarmed a ventilator failure.No injury was reported.
Additional Manufacturer Narrative
The log file was analysed for the investigation.The behaviour described could be reproduced.On the day of the reported event, an implausible pressure difference was detected between the measured pressure values pinsp.And pexsp.According to specification, a safety shutdown was performed due to the detected high pressure on the inspiratory side and an alarm was triggered with "vent fail".The device alarms a ventilator failure with the highest alarm priority acoustically and optically.In this state, manual ventilation can be performed immediately via the manual ventilation bag, spontaneous breathing is also possible.Fresh gas dosing and anaesthetic dosing and monitoring is still possible.Possible causes are a spontaneously increased resistance at the inspiratory port of the breathing system (tube) or moisture in the measuring line of a pressure sensor.The tubes used were therefore tested on a laboratory device.It was not possible to provoke the pneumatic resistance required for a safety shutdown, for example by kinking or twisting the hoses.No moisture could be detected in the measuring lines either.The device was checked on site and no technical failures were found.It was not possible to determine the root cause of the found implausible pressure difference.
Event or Problem Description
It was reported that on (b)(6) 2025, manual ventilation was performed, followed by a switch to automatic ventilation.After approximately two minutes, the atlan a350 alarmed a ventilator failure.No injury was 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: 23072337
• Report Number: 9611500-2025-00525
• Device Sequence Number: 13196167
• Product Code: BSZ
• UDI-Device Identifier: 04048675556176
• UDI-Public: (01)04048675556176(11)221213(93)8621500-13
• 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): 11/07/2025

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: 11/05/2025
• Initial Report FDA Received Date: 09/17/2025
• Supplement Report FDA Received Date: 11/07/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/13/2022
• 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