NOVALUNG CONSOLE (LINUX BOARD)
Received Apr 21, 2026 · Event occurred Mar 30, 2026
Report 3012172416-2026-00030 · MDR key 24938187
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 · Unknown
- 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 THE FACILITY WAS ATTEMPTING TO PLACE A PATIENT ON EXTRACORPOREAL MEMBRANE OXYGENATION (ECMO) SUPPORT. EVERYTHING WAS FINE FOR ABOUT 20 MINUTES UNTIL THEY RECEIVED AN #211 ALARM FROM THE CONSOLE INVOLVING THE FLOW SENSOR. THE FLOW PROBE APPEARED TO BE CLEAN AND CONNECTED APPROPRIATELY. ADDITIONALLY, THEY RECEIVED A SERIES OF AIR ALARMS WITH NO VISIBLE AIR IN THE CIRCUIT AND NO OBVIOUS SOURCE OF AIR. THEY RECEIVED ANOTHER #211 ALARM AND DECIDED TO SWITCH OUT THE FLOW PROBE. THIS DID NOT SOLVE THE ISSUE AND THEY CONTINUED TO GET AIR ALARMS AND AN ADDITIONAL #211 ALARM. THEY FINALLY DECIDED TO SWITCH OUT THE SENSOR BOX WHICH SOLVED THE ISSUE. THERE WAS NO PATIENT SERIOUS INJURY AS A RESULT. IT WAS UNKNOWN IF THE SENSOR BOX OF THE CONSOLE WAS AVAILABLE FOR PRODUCT EVALUATION.