NOVALUNG CONSOLE (LINUX BOARD)
Received Jul 22, 2025 · Event occurred Apr 20, 2025
Report 3012172416-2025-00072 · MDR key 22564072
Device
Generic name
Extracorporeal System For Long-term Respiratory / Cardiopulmonary Failure
Manufacturer
Xenios AgCatalog number
F30000162
Product problems
- Circuit Failure
- Electrical /Electronic Property Problem
- Loss of Power
- Electrical Power Problem
- Circuit Failure
- Electrical /Electronic Property Problem
- Loss of Power
- Electrical Power Problem
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
ADDITIONAL INFORMATION: B5, D9. H6 PLANT INVESTIGATION: NONCONFORMITY WAS NOT OBSERVED DURING THE MANUFACTURING PROCESS. THE REVIEW OF THE REPAIR HISTORY OF THIS CONSOLE SHOWED NO REPAIR ACTIVITIES. UPON INSPECTION, IT WAS FOUND THAT THE INTERNAL FUSES HAD BLOWN. REPLACEMENT FUSES WERE INSTALLED; HOWEVER, THEY BLEW IMMEDIATELY UPON POWERING ON THE DEVICE. THE POWER SUPPLY BOARD WAS RECEIVED AND FORWARDED TO THE SUPPLIER FOR INVESTIGATION. A DEFECT IN THE RETURN POWER SUPPLY BOARD WAS CONFIRMED. A DEFINITIVE CAUSE FOR THE DEFECT COULD NOT BE FOUND. IT WAS DETERMINED THAT A SHORT CIRCUIT HAD CAUSED DAMAGE TO A COMPONENT ON THE POWER SUPPLY BOARD. THIS SHORT CIRCUIT WAS MORE THAN LIKELY CAUSED BY A HIGH VOLTAGE SPIKE FROM THE MAIN POWER SUPPLY. THE DEFECTIVE PARTS INVOLVED HAVE BEEN REPLACED AND THE UNIT WAS RETESTED AS IT PROVIDED THE CORRECT OUTPUT VOLTAGE AS EXPECTED.
Description of Event or Problem
A USER FACILITY REPORTED THAT THE NOVALUNG CONSOLE WAS IN USE ON A PATIENT WHEN THE AC POWER SUPPLY INDICATOR UNEXPECTEDLY DISAPPEARED FROM THE SCREEN, AND THE SYSTEM AUTOMATICALLY SWITCHED TO BATTERY MODE. UPON INSPECTION, IT WAS FOUND THAT THE INTERNAL FUSES HAD BLOWN. REPLACEMENT FUSES WERE INSTALLED; HOWEVER, THEY BLEW IMMEDIATELY UPON POWERING ON THE DEVICE. THE ISSUE WAS REPORTED TO THE XENIOS SERVICE TEAM FOR FURTHER INVESTIGATION AND THEY SUGGESTED TO RETURN THE CONSOLE TO XENIOS. THERE WAS NO RESULTING PATIENT SERIOUS INJURY. THE COMPLAINT SAMPLE WAS RETURNED TO THE MANUFACTURER FOR PRODUCT INVESTIGATION.
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 NOVALUNG CONSOLE WAS IN USE ON A PATIENT WHEN THE AC POWER SUPPLY INDICATOR UNEXPECTEDLY DISAPPEARED FROM THE SCREEN, AND THE SYSTEM AUTOMATICALLY SWITCHED TO BATTERY MODE. UPON INSPECTION, IT WAS FOUND THAT THE INTERNAL FUSES HAD BLOWN. REPLACEMENT FUSES WERE INSTALLED; HOWEVER, THEY BLEW IMMEDIATELY UPON POWERING ON THE DEVICE. THE ISSUE HAS BEEN REPORTED TO THE XENIOS SERVICE TEAM FOR FURTHER INVESTIGATION AND THEY SUGGESTED TO RETURN THE CONSOLE TO XENIOS. THERE WAS NO RESULTING PATIENT SERIOUS INJURY. THE COMPLAINT SAMPLE WAS AVAILABLE FOR PRODUCT INVESTIGATION.