MAUDE Adverse Event Report: LIVANOVA DEUTSCHLAND ESSENZ; CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS

Model Number	COCKPIT COMPLETT
Medical Device Problem Code	Application Program Problem (2880)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/01/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H11: livanova initiated an investigation.If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.
Event or Problem Description
Livanova deutschland received a report of an essenz cockpit restart occurred two times during a procedure.There was no patient injury.
Additional Manufacturer Narrative
Complaints database review revealed that similar events have been reported by other customers.Notably, throughout the essenz hlm cockpit reboot events, the pumps continued to operate fully, and the system remained controllable through the backup control unit with no impact on the clinical procedure.Reboot is an intended mitigation to reestablish the user interface in case of an unrecoverable exception at the tscp board level.This causes the linux operating system to reset the application to resolve the problem.By design, during the reboot, the heart-lung machine's critical functions, including pumps, alarms, sensors, and safety systems, continue to perform as expected.During the reboot, the cockpit screen shows the livanova logo and once the cockpit user interface is restored, the ¿last case¿ button enables users to retrieve all prior settings and proceed without any data loss.Livanova initiated an improvement action in order to further decrease the already low frequency of occurrence of this type of event.The risk is low and in the acceptable region.Livanova will keep monitoring the market.
Event or Problem Description
See initial report.

• Brand Name: ESSENZ
• Common Device Name: CONSOLE, HEART-LUNG MACHINE, 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: 23706075
• Report Number: 9611109-2025-90569
• Device Sequence Number: 16112586
• Product Code: DTQ
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K232291
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/08/2026

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 COMPLETT
• Device Catalogue Number: 49-00-10
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/03/2025
• Supplement Date Received by Manufacturer: 03/13/2026
• Initial Report FDA Received Date: 12/03/2025
• Supplement Report FDA Received Date: 04/08/2026
• Date Device Manufactured: 09/03/2024
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown