NOVALUNG CONSOLE (LINUX BOARD)
Received Jun 12, 2026 · Event occurred May 19, 2026
Report 3012172416-2026-00050 · MDR key 25487612
Device
Generic name
Extracorporeal System For Long-term Respiratory / Cardiopulmonary Failure
Manufacturer
Xenios AgCatalog number
F30000162
Product problems
- Device Alarm System
- Protective Measures Problem
- Insufficient Device Problem Information
Patient
NA · Female
- 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 AN AIR BUBBLE ALARM WAS TRIGGERED ON THE NOVALUNG CONSOLE WITHOUT AIR NOTED IN THE CIRCUIT. THE PATIENT HAD BEEN ON EXTRACORPOREAL MEMBRANE OXYGENATION SUPPORT FOR 4 TO 5 DAYS WHEN THIS ALARM STARTED TO OCCUR DURING THE DAY SHIFT. ADVICE ON TROUBLESHOOTING AIR VERSUS TECHNICAL FAILURE WAS PROVIDED BY THE LOCAL CLINICAL SUPPORT SPECIALIST. THE ALARM RESOLVED WITHOUT INTERVENTION ON ALL SUBSEQUENT SHIFTS. THERE WAS NO PATIENT SERIOUS INJURY OR ADVERSE EVENT RESULTING. THE COMPLAINT SAMPLE WAS RETAINED BY THE USER FACILITY AND UNAVAILABLE FOR PRODUCT EVALUATION.