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

Model Number	COCKPIT
Medical Device Problem Code	Application Program Problem (2880)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/24/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A.1.-a.5.Patient information was not provided.H11: livanova deutschland manufactures the essenz console.The incident occurred in amsterdam, netherlands.The cockpit log files have been requested and analyzed.The analysis confirmed the problem.The backup control unit maintains control during the reboot.In this type of event, the cockpit screen may reboot showing 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.During the reboot, the heart-lung machine's critical functions, including pumps, alarms, sensors, and safety systems, continued to perform as designed.The gas blender may return to the original settings selected by the user and may require the operator to adjust flows if changed during operation.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 that, at the end of the case, the cockpit screen of an essenz console was frozen.It was tried to lower the arterial flow, but it was not visible on the screen.Then, the flow was lowered through the backup control unit, which was also not visible on the cockpit screen.After sixty (60) seconds suddenly the cockpit rebooted by itself and functioned again.Then the lowered flow was visible again on the cockpit (the flow was apparently lowered, but that was not visible on the cockpit where the value was still the same until it rebooted).There was no patient injury.
Additional Manufacturer Narrative
Through follow-up communication, it was learned that the cockpit will be scrapped.A detailed investigation has been conducted.Results revealed that this type of event can be caused by specific high-level processes, such as the logger or window manager applications, which can trigger a segmentation fault or watchdog timeout.This leads the operating system to reset the applications to restore normal operation.Livanova initiated an improvement action in order to further decrease the already low frequency of occurrence of this type of event.The risk is in the acceptable region.No specific action was currently deemed necessary.Livanova will keep monitoring the market.

• 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 80309 ; GM 80309
• Manufacturer Contact: antonella donatiello ; 14401 w. 65th way; arvada, CO 80004
• MDR Report Key: 22076620
• Report Number: 9611109-2025-90137
• Device Sequence Number: 8766336
• Product Code: DTQ
• UDI-Device Identifier: 04033817903048
• UDI-Public: (01)04033817903048(11)241202
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• 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
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/07/2025

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: 28-97-10
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/24/2025
• Supplement Date Received by Manufacturer: 07/23/2025
• Initial Report FDA Received Date: 05/23/2025
• Supplement Report FDA Received Date: 08/07/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/02/2024
• 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
• Patient Sex: Unknown