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

Model Number	8621500
Medical Device Problem Codes	Gas Output Problem (1266); Inaccurate Delivery (2339); Output Problem (3005); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/12/2025
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 the device failed during operation.No injury was reported.
Additional Manufacturer Narrative
The log file provided was analyzed for the investigation.On the day of the event, large external leaks in the breathing circuit were detected in man/spont and alarmed optically and acoustically with "apnea".Also internal leaks were repeatedly detected and alarmed in automatic ventilation mode.Possible causes for these leaks in the respiratory system are the fresh gas decoupling valve, the o2 sensor cap or the inspiratory safety valve.Based on the available data, however, the cause could not be narrowed down any further.Pneumatic leaks during therapy lead to a drop in pressure in the system and a loss of volume.The atlan has integrated pressure monitoring.During therapy, pressure alarms are signaled optically and acoustically according to the alarm limits set by the user (e.G.Lack of fresh gas or leakage, minute volume low, apnea, etc.).All alarms, possible causes and remedial measures are described in the atlan instructions for use.It can be concluded that the atlan has detected both external and internal leaks and informed the user of this condition according to its specification.
Event or Problem Description
It was reported that the device failed during operation.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 23542 ; GM 23542
• Manufacturer Contact: moislinger allee 53-55; lübeck 23542 ; 4518822868
• MDR Report Key: 22094356
• Report Number: 9611500-2025-00276
• Device Sequence Number: 18114168
• Product Code: BSZ
• UDI-Device Identifier: 04048675556176
• UDI-Public: (01)04048675556176(11)231115(93)8621500-15
• 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
• Type of Report: Initial,Followup
• Report Date (Section B): 07/25/2025

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): Initial
• Initial Date Received by Manufacturer: 05/13/2025
• Supplement Date Received by Manufacturer: 07/22/2025
• Initial Report FDA Received Date: 05/28/2025
• Supplement Report FDA Received Date: 07/25/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/15/2023
• 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