NOVALUNG CONSOLE (LINUX BOARD)
Received May 4, 2026 · Event occurred Apr 4, 2026
Report 3012172416-2026-00032 · MDR key 25067004
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
Description of Event or Problem
A USER FACILITY REPORTED THAT A #00A ALARM OCCURRED AFTER PRIMING THE SYSTEM. BEFORE THE USER ATTEMPTED TO CONNECT THE XLUNG KIT 230 CIRCUIT TO THE PATIENT, THE USER WAS UNABLE TO RESOLVE THE ALARM. THE USER EXCHANGED THE PUMP DRIVE WHICH RESOLVED THE ALARM AND THE PATIENT WAS ABLE TO CONTINUE SUPPORT. THERE WAS NO PATIENT INVOLVEMENT. THE PUMP DRIVE COMPONENT OF THE CONSOLE WAS AVAILABLE FOR PRODUCT EVALUATION.
Additional Manufacturer Narrative
THE PLANT INVESTIGATION IS IN PROCESS. A SUPPLEMENTAL MDR WILL BE SUBMITTED UPON COMPLETION OF THIS ACTIVITY.