MAUDE Adverse Event Report: LivaNova Deutschland Essenz Console Plus; Console, Heart-Lung Machine, Cardiopulmonary Bypass

Model Number	CONSOLE PLUS
Medical Device Problem Code	Application Program Problem (2880)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/27/2026
Type of Reportable Event	Malfunction
Event or Problem Description
Livanova deutschland received report that essenz hlm cockpit rebooted by itself during procedure.Reportedly, the pump remained controllable using the backup control unit.There was no patient injury.
Additional Manufacturer Narrative
A1-a5 patient information was not provided.H11 reportedly, perfusionist selected the profile and returned to operating the pump through the cockpit without any further problem.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 remains controllable through the backup control unit with no impact on the clinical procedure.Essenz hlm reboot is a rare event and represents a recovery mechanism designed to restore cockpit functionality in the unlikely case that the system enters a state that cannot be recovered by software.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.Livanova has in place a continuous improvement process in which enhancements and new functionalities are regularly integrated into essenz hlm future software revisions.These updates are part of the company¿s standard product lifecycle and development roadmap, rather than corrective actions tied to specific reported events.Devices in the field are typically updated to the latest software revision during scheduled periodic maintenance activities, in accordance with standard service procedures.This approach ensures that system remains current and helps prevent potential issues by proactively incorporating improvements over time.The risk is in the acceptable region.No specific action was currently deemed necessary.Livanova will keep monitoring the market.

• Brand Name: Essenz Console Plus
• 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: 50884930
• Report Number: 9611109-2026-90451
• Device Sequence Number: 16129309
• Product Code: DTQ
• UDI-Device Identifier: 04033817903062
• 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
• Type of Report: Initial
• Report Date (Section B): 09/24/2026

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: CONSOLE PLUS
• Device Catalogue Number: 49-00-10
• 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: 08/27/2026
• Initial Report FDA Received Date: 09/24/2026
• Date Device Manufactured: 03/25/2026
• Patient Sequence Number: 1
• Patient Sex: Unknown