NOVALUNG CONSOLE (LINUX BOARD)
Received Aug 19, 2025 · Event occurred Aug 1, 2025
Report 3012172416-2025-00082 · MDR key 22838530
Device
Generic name
Extracorporeal System For Long-term Respiratory / Cardiopulmonary Failure
Manufacturer
Xenios AgModel number
NOVALUNG CONSOLE (LINUX BOARD)Catalog number
F30000162
Product problems
- Incorrect, Inadequate or Imprecise Result or Readings
- Output Problem
- Insufficient Device Problem Information
- Incorrect, Inadequate or Imprecise Result or Readings
- Output Problem
- Insufficient Device Problem Information
Patient
NA · Unknown
- No Consequences Or Impact To Patient
- Insufficient Information
- No Clinical Signs, Symptoms or Conditions
- No Consequences Or Impact To Patient
- Insufficient Information
- No Clinical Signs, Symptoms or Conditions
Narrative
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 ON (B)(6) 2025 AT APPROXIMATELY 7:15 PM (LOCAL), THE XENIOS CONSOLE (S/N: (B)(6), WHICH HAD BEEN ON STANDBY AND PRIMED SINCE ON (B)(6) 2025 AT 2800 RPM AND 2.0 L/MIN FLOW, UNEXPECTEDLY SWITCHED TO EMERGENCY MODE AND TWO CRITICAL ALARMS WERE TRIGGERED: # 403 - TECHNICAL FAILURE: OPERATOR PANEL AND #10E - PUMP DRIVE IN EMERGENCY MODE. THIS WAS ACCOMPANIED BY CONTINUOUS AUDIBLE WARNING. UPON INSPECTION, THE TOUCH PANEL WAS RESPONSIVE, BUT THE ROTARY KNOB AND SWITCH KEYS WERE NONFUNCTIONAL. AFTER REMOVING AND INSERTING THE CONSOLE´S BATTERIES, THE SYSTEM RESTARTED AND FUNCTIONED NORMALLY. THERE WAS NO PATIENT INVOLVEMENT. THE COMPLAINT SAMPLE WAS NOT AVAILABLE FOR PRODUCT EVALUATION.
Additional Manufacturer Narrative
ADDITIONAL INFORMATION: 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 CONSOLE SHOWED NO REPAIR ACTIVITIES. THE CONSOLE WAS INSPECTED ONSITE, AND THE REPORTED FAILURE COULD NOT BE REPRODUCED. NO DEFECT WAS FOUND. A SOFTWARE UPDATE TO THE LATEST VERSION (3.2.4) HAS BEEN PERFORMED, AND THE DEVICE IS READY FOR USE AGAIN.
Description of Event or Problem
A USER FACILITY REPORTED THAT ON (B)(6) 2025 AT APPROXIMATELY 7:15 PM (LOCAL), THE XENIOS CONSOLE (S/N (B)(6)), WHICH HAD BEEN ON STANDBY AND PRIMED SINCE (B)(6) 2025 AT 2800 RPM AND 2.0 L/MIN FLOW, UNEXPECTEDLY SWITCHED TO EMERGENCY MODE AND TWO CRITICAL ALARMS WERE TRIGGERED: # 403 - TECHNICAL FAILURE: OPERATOR PANEL AND #10E - PUMP DRIVE IN EMERGENCY MODE. THIS WAS ACCOMPANIED BY CONTINUOUS AUDIBLE WARNING. UPON INSPECTION, THE TOUCH PANEL WAS RESPONSIVE, BUT THE ROTARY KNOB AND SWITCH KEYS WERE NONFUNCTIONAL. AFTER REMOVING AND INSERTING THE CONSOLE´S BATTERIES, THE SYSTEM RESTARTED AND FUNCTIONED NORMALLY. THERE WAS NO PATIENT INVOLVEMENT. THE COMPLAINT SAMPLE WAS NOT AVAILABLE FOR PRODUCT EVALUATION.