MAUDE Adverse Event Report: LIVANOVA DEUTSCHLAND ESSENZ HLM; 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	10/20/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Livanova deutschland received a report of an essenz hlm cockpit which initially froze and after about 5 mins the screen turned black and restarted.When the home screen reappeared the button 'last case' was not present, so a new profile needed to be opened.Case was completed successfully.The event occurred during procedure.There was no patient injury.
Additional Manufacturer Narrative
A1 to a5: patient information was not provided.H11: livanova manufactures the essenz hlm, the event occurred in sweden.Livanova has started an investigation.If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.
Additional Manufacturer Narrative
H11 complaints database review revealed that similar events have been reported by other customers.Notably, throughout the reboot event , 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 HLM
• 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 ; arvada, CO 80004
• MDR Report Key: 23633412
• Report Number: 9611109-2025-90551
• Device Sequence Number: 9316968
• Product Code: DTQ
• Combination Product (Y/N): N
• Initial Reporter Country: SW
• 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
• Type of Report: Initial,Followup
• Report Date (Section B): 04/07/2026

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
• Device Model Number: COCKPIT COMPLETT
• Device Catalogue Number: 28-97-10
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/20/2025
• Supplement Date Received by Manufacturer: 03/11/2026
• Initial Report FDA Received Date: 11/24/2025
• Supplement Report FDA Received Date: 04/07/2026
• Date Device Manufactured: 06/30/2025
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown