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	05/13/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the device posted an alarm for a ventilation failure.Manual ventilation was possible.No injury reported.
Additional Manufacturer Narrative
Investigation was performed by means of the provided device log file.The entries confirm the reported ventilator failure for the reported date of event.It was found that the measured tidal volume reached the max tidal volume limit.The device measured an unplausible high inspiratory pressure.Due to this the expiratory safety valve opens and the supply voltage of the ventilator and the relevant valves are deactivated.An audible and visible "ventilator failure" alarm was posted.Manual ventilation is still possible.This entry could be traced in the logs.No indication for a device failure was found.For the current case it is therefore assumed that the ventilator did not stop because of a ventilator issue but due to a high measured inspiratory pressure which can be caused by a temporary high inspiratory resistance or patient activity.Finally, it can be concluded that the atlan has reacted on the detected high inspiratory pressure as specified by performing a safety shutdown of the ventilator accompanied by a corresponding alarm.

• 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: 22094533
• Report Number: 9611500-2025-00278
• Device Sequence Number: 12768033
• Product Code: BSZ
• UDI-Device Identifier: 04048675556183
• UDI-Public: (01)04048675556183(11)200511(93)8621600-08
• Combination Product (Y/N): N
• PMA/510(K) Number: K0230931
• 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
• Report Date (Section B): 05/28/2025

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
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/27/2025
• Initial Report FDA Received Date: 05/28/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/06/2020
• 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
• Concomitant Medical Products and Therapy/Usage Dates: NA.
• Patient Sex: Unknown