NOVALUNG CONSOLE (LINUX BOARD)
Received Aug 11, 2025 · Event occurred Jul 25, 2025
Report 3012172416-2025-00075 · MDR key 22769762
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
- Device Alarm System
- Protective Measures Problem
- Insufficient Device Problem Information
Patient
NA · Unknown
- No Consequences Or Impact To Patient
- No Clinical Signs, Symptoms or Conditions
- No Consequences Or Impact To Patient
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
A USER FACILITY REPORTED AN ERROR 208 MESSAGE ON THE NOVALUNG CONSOLE DURING PRIMING FOR EXTRACORPOREAL MEMBRANE OXYGENATION SUPPORT. THERE WAS NO PATIENT INVOLVEMENT. THE COMPLAINT SAMPLE WAS RECEIVED FOR PRODUCT INVESTIGATION.
Additional Manufacturer Narrative
ADDITIONAL INFORMATION: B5, D9, H3, H6 PLANT INVESTIGATION: NON-CONFORMITY WAS NOT OBSERVED DURING MANUFACTURING PROCESS. THE REVIEW OF THE REPAIR HISTORY IN THE QTRAK COMPLAINT AMD SYSTEM OF THE DEVICES XEN0648 AND XCON0550 SHOWED NO REPAIR ACTIVITIES. THE MACHINE FILES OF THE CONSOLE WERE PROVIDED, AND THE SENSOR BOX WAS RETURNED FOR EVALUATION AND RECEIVED ON SEPTEMBER 16, 2025. THE ALARM 208 INDICATES A TECHNICAL FAILURE OF THE FLOW MEASUREMENT (FAILURE OF THE COMMUNICATION TO THE PRINTED CIRCUIT BOARD IN THE SENSOR BOX. THE MACHINE FILES SHOW THAT ALARM 208 OCCURRED ON (B)(6) 2025, AT 11:21 P.M., AND THE FLOW WAS NO LONGER DISPLAYED. HOWEVER, VISUAL INSPECTION OF THE SENSOR BOX SHOWED NO DEFECT, AND ELECTRICAL TESTING REVEALED NO ABNORMALITY. THE ALARM COULD NOT BE REPRODUCED DURING THE FUNCTIONAL TEST.
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 AN ERROR 208 MESSAGE ON THE NOVALUNG CONSOLE DURING PRIMING FOR EXTRACORPOREAL MEMBRANE OXYGENATION SUPPORT. THERE WAS NO PATIENT INVOLVEMENT. THE COMPLAINT SAMPLE WAS AVAILABLE FOR PRODUCT INVESTIGATION.