NOVALUNG CONSOLE (LINUX BOARD)
Received Feb 12, 2026 · Event occurred Jan 23, 2026
Report 3012172416-2026-00008 · MDR key 24321440
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 · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
ADDITIONAL INFORMATION: B5, D9 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 FOLLOWING APPROXIMATELY 10 MINUTES AFTER PRIMING THE SYSTEM, THE CONSOLE SHOWED ERROR '206/208'. THE FLOW SENSOR WAS REPOSITIONED BUT DID NOT SOLVE THE ISSUE. THE ERROR MESSAGE WAS REPEATEDLY DISPLAYED UNTIL THE CONSOLE AND KIT WERE EXCHANGED DUE TO THERAPEUTIC REASONS AND NOT BECAUSE OF THE ERROR MESSAGES. ON (B)(6) 2026, A FIELD TECHNICIAN CHECKED THE SENSOR BOX AND BUILT-IN VOLTAGE REGULATOR. IT WAS FOUND THAT THE SENSOR BOX WAS NOT UPDATED WITH THE FIELD CORRECTION AS THE DEVICE WAS TOO OLD. THE CONSOLE WAS FIXED ON SITE. THE REPLACED COMPONENT WAS RETURNED TO XENIOS FOR PRODUCT INVESTIGATION. THERE WAS NO PATIENT INVOLVEMENT.
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 FOLLOWING APPROXIMATELY 10 MINUTES AFTER PRIMING THE SYSTEM, THE CONSOLE SHOWED ERROR '206/208'. THE FLOW SENSOR WAS REPOSITIONED BUT DID NOT SOLVE THE ISSUE. THE ERROR MESSAGE WAS REPEATEDLY DISPLAYED UNTIL THE CONSOLE AND KIT WERE EXCHANGED DUE TO THERAPEUTICAL REASONS AND NOT BECAUSE OF THE ERROR MESSAGES. ON (B)(6) 2026, A FIELD TECHNICIAN CHECKED THE SENSOR BOX AND BUILT IN VOLTAGE REGULATOR. IT WAS FOUND THAT THE SENSOR BOX WAS NOT UPDATED WITH THE FIELD CORRECTION AS THE DEVICE WAS TOO OLD. THERE WAS NO PATIENT INVOLVEMENT. THE COMPLAINT SAMPLE WAS AVAILABLE FOR PRODUCT EVALUATION.