NOVALUNG CONSOLE (LINUX BOARD)
Received Mar 18, 2026 · Event occurred Feb 6, 2026
Report 3012172416-2026-00023 · MDR key 24625579
Device
Generic name
Extracorporeal System For Long-term Respiratory / Cardiopulmonary Failure
Manufacturer
Xenios AgCatalog number
F30000162
Product problems
- Circuit Failure
- 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 WHEN EXTRACORPOREAL MEMBRANE OXYGENATION SUPPORT WAS INITIATED ON (B)(6) 2026, SEVERAL ALARMS, INCLUDING #008, #00A, #238 AND #239, WERE NOTED BY THE USER. A NURSE TRIED TO RESTART THE DEVICE, BUT ALARMS PERSISTED WITH NEARLY NO PARAMETERS DISPLAYED ON THE CONSOLE. AFTER SOME TIME OR SOME OPERATION (EXACT DETAILS NOT PROVIDED), THERE WAS ONLY THE #00A ALARM. THE USER TRIED TO START THE SECOND DP3 AND A TECHNICIAN WAS CONTACTED. WHEN THE TECHNICIAN ARRIVED ONSITE, IT WAS SUGGESTED THAT THE PATIENT BE TRANSFERRED TO ANOTHER DEVICE FOR SAFETY PURPOSES; HOWEVER, THE USER HAD NO OTHER DEVICE AVAILABLE AND SUPPORT COULD NOT BE PAUSED. NO FURTHER TESTING WAS ABLE TO BE CONDUCTED BY THE TECHNICIAN. A NEW SENSOR BOX AND DP3 WERE PROVIDED BY THE FACILITY. AFTER THE SPARE PARTS ARRIVED, THE #00A ALARM REMAINED WHEN THE SENSOR BOX WAS REPLACED, BUT RESOLVED AFTER REPLACING THE DP3, AND SUPPORT WAS ABLE TO CONTINUE. THERE WAS NO SPECIFIED RESULTING PATIENT SERIOUS INJURY. THE CONSOLE¿S PUMP DRIVE 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.