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

Model Number	8621500
Medical Device Problem Codes	Gas Output Problem (1266); Use of Device Problem (1670)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/22/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The investigation has just started; results will be provided in a follow-up report.
Event or Problem Description
It was reported that the equipment failed during ventilation.No injury was reported.
Additional Manufacturer Narrative
For the investigation the provided logfile was analysed, which, however, did not contain the reported date of event.The logfile was in general searched for breathing system failures and ventilator failures.No such failures were found.Some days before the reported date of event the device detected deviations during selftest and signaled these to the user, for example the battery not charged and a too low central supply pressure.During the system test of the atlan a350 the system gets tested for possible operational restrictions of the system.A calibration of all valves and sensors is done and all device functions get tested.Further, leakages, system compliance and system resistance get calculated.After the test, the final test result is displayed on the standby screen.Ventilator malfunctions are recognised by the device in the daily system test.During therapy, alarms are signalled visually and acoustically.The device would alarm a ventilator failure with the highest alarm priority acoustically and visually.In this state, manual ventilation can be performed immediately via the manual ventilation bag (spontaneous breathing is also possible).The user is notified on the screen to confirm the change of therapy.Fresh gas dosing and anaesthetic dosing via the connected vapore are still possible, and monitoring is also retained.All alarms and the ventilator failure are described in the atlan instructions for use.No problems during ventilation were found.It was not possible to reproduce the described problem on the basis of the provided information.
Event or Problem Description
It was reported that the equipment failed during ventilation.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: 22192521
• Report Number: 9611500-2025-00305
• Device Sequence Number: 18469195
• Product Code: BSZ
• UDI-Device Identifier: 04048675556176
• UDI-Public: (01)04048675556176(11)240112(93)8621500-15
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• 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): 11/28/2025

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: 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: 05/28/2025
• Supplement Date Received by Manufacturer: 11/24/2025
• Initial Report FDA Received Date: 06/12/2025
• Supplement Report FDA Received Date: 11/28/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/12/2024
• 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