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

Model Number	8609141
Medical Device Problem Codes	Use of Device Problem (1670); Failure to Deliver (2338)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/30/2024
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
Vent fail message during use.No patient injury reported.
Event or Problem Description
Vent fail message during use.No patient injury reported.
Additional Manufacturer Narrative
The hospital biomed checked the electronic log file and found entries related to a blocked pressure sensor.The atlan was analyzed by a dräger service technician subsequently.The pressure sensor was checked without finding.The printed circuit board (pba connector board) was replaced to remedy a potential failure related to the pressure measurement.The board was returned to the manufacturing site and subject to both visual inspection and a functional test in a comparable atlan device.The reported issue could not be reproduced.The root cause could finally not be determined.The atlan detected a deviation related to the pressure sensor and reacted as specified by stopping mechanical ventilation and generating a correspond alarm.In case mechanical ventilation fails, manual ventilation, gas dosage and monitoring remain available to continue the case.The number of similar cases, related to the same phenomenon, 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: 21310013
• Report Number: 9611500-2025-00060
• Device Sequence Number: 12964977
• Product Code: BSZ
• UDI-Device Identifier: 04048675556183
• UDI-Public: (01)04048675556183(11)240607(93)8621600-17
• Combination Product (Y/N): N
• PMA/510(K) Number: K230931
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date (Section B): 03/13/2025

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: 8609141
• Device Catalogue Number: 8609141
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/10/2025
• Supplement Date Received by Manufacturer: 03/12/2025
• Initial Report FDA Received Date: 02/05/2025
• Supplement Report FDA Received Date: 03/13/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/07/2024
• 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
• Patient Sex: Unknown