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	08/24/2026
Type of Reportable Event	Malfunction
Event or Problem Description
Livanova deutschland received report that, before initiating procedure, essenz hlm cockpit rebooted by itself.Reportedly, perfusionist started a new case and the procedure was completed without further problems.There was no patient injury.
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.

• 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: 50836341
• Report Number: 9611109-2026-90439
• Device Sequence Number: 10059879
• Product Code: DTQ
• UDI-Device Identifier: 04033817903062
• 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
• Type of Report: Initial
• Report Date (Section B): 09/21/2026

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: 08/24/2026
• Initial Report FDA Received Date: 09/21/2026
• Date Device Manufactured: 05/11/2023
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown