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

Model Number	CONSOLE PLUS
Medical Device Problem Code	Unexpected Shutdown (4019)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/29/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A1-a5 patient information was not provided.H11 livanova deutschland manufactures the essenz console plus, the event occurred in united states.Livanova field service engineer was dispatched to customer facility and could not reproduce the issue; as a precautionary measure, he replaced the cockpit and the unit returned to service.Investigation is ongoing.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 the essenz hlm cockpit rebooted during procedure.There is no patient injury.
Additional Manufacturer Narrative
H11.Through follow up communication it was confirmed that the reboot occurred during a case.If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.
Event or Problem Description
See initial report.

• 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 ; arvada, CO 80004
• MDR Report Key: 23836094
• Report Number: 9611109-2025-90607
• Device Sequence Number: 5067929
• 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
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/15/2026

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: 11/18/2025
• Supplement Date Received by Manufacturer: 01/27/2026; 05/19/2026
• Initial Report FDA Received Date: 12/18/2025
• Supplement Report FDA Received Date: 02/25/2026; 06/15/2026
• Date Device Manufactured: 05/10/2024
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown