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

Model Number	8621600
Medical Device Problem Codes	Gas Output Problem (1266); Incorrect Interpretation of Signal (1543); Failure to Deliver (2338)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/24/2025
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 the (b)(6) 2025 around 16.40, while the patient was on the ventilator, the device alarmed for a ventilator failure.No injury was reported.
Additional Manufacturer Narrative
For the investigation, the provided log file was analysed.The log file showed that during the time of the reported incident the device issued several alarms for "airway pressure high" and "airway pressure continuous high" and as a consequence "ventilator failure" in different ventilation modes.The atlan is equipped with integrated pressure, volume and gas monitoring (optionally integrated).During therapy, alarms are signaled visually and acoustically according to the alarm limits set by the user.The airway pressure is shown on the atlan display (measured value and curve).If the pressure in the breathing circuit rises, the atlan alerts ¿airway pressure high¿ if the upper alarm limit for the airway pressure has been exceeded.The atlan alerts ¿airway pressure continuous high¿ if the measured pressure is >15 seconds above the set limit.If the airway pressure rises more than 10 mbar above the pmax value set by the user, first the peep valve, then the safety valve is opened to reduce the pressure.After 500 ms of continous pressure, the ventilator is stopped and a ventilator failure is alarmed.Manual ventilation is still possible, as it was in this particular case.Root cause for the ventilator failures was a faulty expiratory pressure sensor.On site the pressure sensors were replaced, the device was tested and returned to the customer.No further problems were described.The number of similar cases, related to the same issue, is within the expected range of the respective risk assessment and thus accepted.
Event or Problem Description
It was reported that, on the (b)(6) 2025, around 16.40 pm, while the patient was on the ventilator, the device alarmed for a ventilator failure.No injury was reported.

• Brand Name: ATLAN A350 XL
• 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: 21706770
• Report Number: 9611500-2025-00157
• Device Sequence Number: 10072394
• Product Code: BSZ
• UDI-Device Identifier: 04048675556183
• UDI-Public: (01)04048675556183(11)230301(93)8621600-15
• Combination Product (Y/N): N
• 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): 06/26/2025

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: 8621600
• 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: 03/07/2025
• Supplement Date Received by Manufacturer: 06/16/2025
• Initial Report FDA Received Date: 03/27/2025
• Supplement Report FDA Received Date: 06/26/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/01/2023
• 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
• Patient Sex: Unknown