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

Model Number	8621500
Medical Device Problem Codes	Gas Output Problem (1266); Decrease in Pressure (1490); Appropriate Device Problem Term/Code Not Available (3191); Intermittent Communication Failure (4038)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/12/2025
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 atlan has been displaying error codes while in use (err messages in display), and the unit was reported to have shutdown down late yesterday after displaying err, display went black and the unit shutdown.No reported patient injury.
Event or Problem Description
It was reported that the atlan has been displaying error codes while in use (err messages in display), and the unit was reported to have shutdown down late yesterday after displaying err, display went black and the unit shutdown.No reported patient injury.
Additional Manufacturer Narrative
For the investigation the provided logfile was analyzed.The reported ¿err messages¿ being reportedly alarmed prior to the restart could neither be reconstructed nor confirmed.Nevertheless it was found that on the date of event the system performed a reboot during ongoing ventilation.In case of such a reboot, therapy is be interrupted briefly.After a maximum of 15 s, the ventilation is automatically continued with the latest valid device setting as it was in this special case.Manual ventilation remains possible at all time.Root cause for the reboot was a problem within the memory allocation.This memory allocation takes place via the m48 board, it was found that a sd card, which is located on this board, was faulty.On site the respective sd card was replaced and the device was tested according to the manufacturer's specifications.The number of similar cases, related to the same root cause, is within the expected range of the respective risk assessment and thus accepted.The ffr is monitored in the responsible pqb, in case it is decided that measures are necessary, this is derived from the pqb.

• 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: 22288925
• Report Number: 9611500-2025-00321
• Device Sequence Number: 8373836
• Product Code: BSZ
• UDI-Device Identifier: 04048675556176
• UDI-Public: (01)04048675556176(11)240808(93)8621500-17
• Combination Product (Y/N): N
• Initial Reporter Country: US
• 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: Biomedical Engineer
• 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: 8621500
• 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: 05/29/2025
• Supplement Date Received by Manufacturer: 07/25/2025
• Initial Report FDA Received Date: 06/19/2025
• Supplement Report FDA Received Date: 07/29/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/08/2024
• 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