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

Model Number	8621500
Medical Device Problem Codes	Decrease in Pressure (1490); Inaccurate Delivery (2339); Gas/Air Leak (2946)
Health Effect - Clinical Code	Cardiac Arrest (1762)
Date of Event	05/20/2026
Type of Reportable Event	Serious Injury
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 a patient experienced a cardiac arrest during a surgical procedure.The users did not allege a device malfunction and admitted that they did not recognize the alarms the device had posted during the course of event.
Additional Manufacturer Narrative
The investigation of the log file demonstrates that there was no issue with the device which would require repair or correction.At a certain point in time the device did not sense a valid breath anymore and posted an apnea alarm, shortly afterwards was a fresh gas deficit detected and the corresponding alarm was posted.The device did then initiate countermeasures to equalize the fresh gas deficit - the emergency air inlet was activated to take in room air, and the device posted the dedicated alarm which was reportedly noticed by the user.About 2.5 minutes after the first apnea alarm there was user interaction with the device, the alarm silence button was pressed which deactivates the audio alarms for 2 minutes.The entire sequence of disturbances lasted approx.10 minutes, the ventilation was unremarkable and stable again afterwards.The user admitted to dräger that the ventilation hose became detached from the inspiratory port which caused the leak and the resulting fresh gas deficit.Dräger concludes that the device has responded as designed upon the disturbances in ventilation which were caused by non-device related aspects.The delay in operator intervention which has presumably contributed to the deterioration in patient's health was also caused by factors outside the control mechanisms the device manufacturer can establish.
Event or Problem Description
It was reported that a patient experienced a cardiac arrest during a surgical procedure.The users did not allege a device malfunction and admitted that they did not recognize the alarms the device had posted during the course of event.

• 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: 25483760
• Report Number: 9611500-2026-00290
• Device Sequence Number: 18754187
• Product Code: BSZ
• UDI-Device Identifier: 04048675556176
• UDI-Public: (01)04048675556176(11)250821(93)8621500-20
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/19/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• 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: 05/20/2026
• Supplement Date Received by Manufacturer: 06/18/2026
• Initial Report FDA Received Date: 06/12/2026
• Supplement Report FDA Received Date: 06/22/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/21/2025
• 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
• Outcome Attributed to Adverse Event: Life Threatening
• Patient Sex: Unknown