NOVALUNG CONSOLE (LINUX BOARD)
Received Mar 11, 2026 · Event occurred Dec 17, 2025
Report 3012172416-2026-00020 · MDR key 24574362
Device
Generic name
Extracorporeal System For Long-term Respiratory / Cardiopulmonary Failure
Manufacturer
Xenios AgCatalog number
F30000162
Product problems
- Electrical /Electronic Property Problem
- Insufficient Device Problem Information
Patient
NA · Male
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
THE PLANT INVESTIGATION IS IN PROCESS. A SUPPLEMENTAL MDR WILL BE SUBMITTED UPON COMPLETION OF THIS ACTIVITY.
Description of Event or Problem
A USER FACILITY REPORTED THAT APPROXIMATELY 30 TO 45 MINUTES AFTER INITIATION OF SUPPORT, A TEMPORARY MALFUNCTION OF THE EXTRACORPOREAL MEMBRANE OXYGENATION (ECMO) SYSTEM OCCURRED. THE EVENT WAS CHARACTERIZED BY A BRIEF SHUTDOWN OF THE CONSOLE DISPLAY AND A SHORT INTERRUPTION OF BLOOD FLOW. FOLLOWING SPONTANEOUS RECOVERY OF THE CONSOLE, AN ALARM INDICATING LOSS OF COMMUNICATION BETWEEN THE SENSOR BOX AND THE CONSOLE WAS DISPLAYED. IMMEDIATE CLINICAL ACTIONS WERE TAKEN, INCLUDING CLAMPING OF THE CANNULAS AND RESTORATION OF BLOOD FLOW. THE SYSTEM RESUMED NORMAL OPERATION AFTER A SHORT INTERRUPTION AND CONTINUED TO FUNCTION WITHOUT RECURRENCE FOR THE REMAINDER OF THE ECMO SUPPORT. THERE WAS NO PATIENT SERIOUS INJURY. THE COMPLAINT SAMPLE WAS AVAILABLE FOR PRODUCT EVALUATION.