MAUDE Adverse Event Report: LIVANOVA DEUTSCHLAND ELECTRONIC GAS BLENDER; GAS CONTROL UNIT, CARDIOPULMONARY BYPASS

Model Number	COCKPIT
Medical Device Problem Codes	Gas Output Problem (1266); Application Program Freezes or Fails to Launch (4031)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/12/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Livanova received a report of an essenz cockpit which froze during procedure.Reportedly, the electronic gas blender shut off as consequence of cockpit freezing.The event occurred during procedure.There was no patient injury.
Additional Manufacturer Narrative
A.1.-a.5.Patient information was not provided.H11: through follow-up communication, the following information were received by livanova: the cockpit was frozen between 13:15 and 13:20, for 5 minutes; the screen did not become black in this period.During the failure, no area of the cockpit was functional.After cockpit freeze, the device returned functional and could be used properly.Reportedly, the electronic gas blender (egb) linked to the heart lung machine was shut off due to the cockpit issue.The cockpit log files were analysed, and no egb technical or communication error during the event timeframe was shown.The serdat log file from essenz perfusion monitor used during procedure were analysed: data showed values of fio2, co2 and "total flow" every 10 seconds, with no significant change during the time window of the event: co2 was always 0 during the entire procedure, fio2 was in the range [0,68;0,82] and total flow was in the range [2;3].Livanova initiated an investigation.If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.

• Brand Name: ELECTRONIC GAS BLENDER
• Common Device Name: GAS CONTROL UNIT, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): LIVANOVA DEUTSCHLAND; lindberghstrasse 25; munich 80939 ; GM 80939
• Manufacturer (Section G): LIVANOVA DEUTSCHLAND; lindberghstrasse 25; munich 80939 ; GM 80939
• Manufacturer Contact: annarita di lascio ; 14401 w. 65th way; arvada, CO 80004
• MDR Report Key: 23325428
• Report Number: 9611109-2025-90445
• Device Sequence Number: 9937812
• Product Code: DTX
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: K101046
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/21/2026

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: COCKPIT
• Device Catalogue Number: 25-40-45
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/18/2025
• Supplement Date Received by Manufacturer: 05/27/2026; 06/23/2026
• Initial Report FDA Received Date: 10/17/2025
• Supplement Report FDA Received Date: 05/29/2026; 07/21/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/20/2023
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown