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

Model Number	8621600
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	06/25/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The investigation is still on going.The results will be provided with a follow-up report.
Event or Problem Description
It was reported that the device displayed the error ¿ventilator failure, please ventilate manually¿ during pc ventilation.Manual ventilation was possible without any problems.No injury reported.
Event or Problem Description
It was reported that the device displayed the error ¿ventilator failure, please ventilate manually¿ during pc ventilation.Manual ventilation was possible without any problems.No injury reported.
Additional Manufacturer Narrative
The logfile was analysed.It was found that the device forced a safety shutdown of automatic ventilation due to a too high detected inspiratory pressure.The device posted the corresponding ¿ventilator failure¿ alarm.Manual ventilation and the monitoring functions remain available to the full extent.Possible reasons can be a sporadic high resistance in the hose system due to squeezed hoses, patient activity or repositioning of the patient.As the device passed the system and leakage test before and after the case in question without any deviations a device failure seems unlikely.Finally, the exact cause of the inspiratory high pressure could not be identified.It can be concluded that the device has reacted on the detected pressure situation as specified by triggering a safety shutdown and posting the corresponding alarm.The number of similar cases, related to the same root cause, is within the expected range of the respective risk assessment and thus accepted.

• 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: 22413069
• Report Number: 9611500-2025-00356
• Device Sequence Number: 15542016
• Product Code: BSZ
• UDI-Device Identifier: 04048675556183
• UDI-Public: (01)04048675556183(11)200511(93)8621600-08
• 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): 07/29/2025

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?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 06/25/2025
• Supplement Date Received by Manufacturer: 07/25/2025
• Initial Report FDA Received Date: 07/07/2025
• Supplement Report FDA Received Date: 07/29/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/11/2020
• 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