NOVALUNG CONSOLE (LINUX BOARD)
Received Jul 10, 2025 · Event occurred Jun 19, 2025
Report 3012172416-2025-00061 · MDR key 22467669
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
Additional Manufacturer Narrative
ADDITIONAL INFORMATION: B5, D9 PLANT INVESTIGATION: NON-CONFORMITY WAS NOT OBSERVED DURING THE MANUFACTURING PROCESS. NO OTHER COMPLAINTS HAVE BEEN REPORTED CONCERNING THIS CONSOLE. FIELD SERVICE TECHNICIANS EVALUATED THE DEVICE ONSITE AND COULD NOT REPLICATE THE ERROR. NO DEFECTS WERE FOUND; THE DEVICE WAS OPERATING AS INTENDED UPON DEVICE EVALUATION. A REVIEW OF PROVIDED MACHINE LOG DATA INDICATES THAT THE ALARMS OCCURRED DUE TO A DELAYED SYSTEM START. APART FROM THE ALARMS, NO FURTHER ISSUES ARE VISIBLE IN THE DATA. THE CAUSE OF THE DELAYED START IS UNKNOWN.
Description of Event or Problem
A USER FACILITY REPORTED THAT THERE WERE REPEATED AND MULTIPLE TECHNICAL FAILURE ALARMS WHILE SETTING UP AND TESTING THE SYSTEM. THE USER NOTED TECHNICAL FAILURE ALARMS - #009 - TECHNICAL FAILURE, CONTROL PANEL (INTERNAL COMMUNICATION ERROR) AND #00B - TECHNICAL FAILURE, CONTROL PANEL (AUDIBLE ALARM MALFUNCTION). ADDITIONALLY, THE USER PROVIDED VIDEO OF THE SYSTEM POWERED ON WITH A BLANK SCREEN ON THE CONTROL PANEL AND AN AUDIBLE ALARM. THERE WAS NO PATIENT INVOLVEMENT. THE COMPLAINT SAMPLE WAS AVAILABLE FOR PRODUCT EVALUATION BUT NOT RETURNED TO THE MANUFACTURER FOR INVESTIGATION.
Additional Manufacturer Narrative
ADDITIONAL INFORMATION: B5, D9 PLANT INVESTIGATION: NON-CONFORMITY WAS NOT OBSERVED DURING THE MANUFACTURING PROCESS. NO OTHER COMPLAINTS HAVE BEEN REPORTED CONCERNING THIS CONSOLE. FIELD SERVICE TECHNICIANS EVALUATED THE DEVICE ONSITE AND COULD NOT REPLICATE THE ERROR. NO DEFECTS WERE FOUND; THE DEVICE WAS OPERATING AS INTENDED UPON DEVICE EVALUATION. A REVIEW OF PROVIDED MACHINE LOG DATA INDICATES THAT THE ALARMS OCCURRED DUE TO A DELAYED SYSTEM START. APART FROM THE ALARMS, NO FURTHER ISSUES ARE VISIBLE IN THE DATA. THE CAUSE OF THE DELAYED START IS UNKNOWN.
Description of Event or Problem
A USER FACILITY REPORTED THAT THERE WERE REPEATED AND MULTIPLE TECHNICAL FAILURE ALARMS WHILE SETTING UP AND TESTING THE SYSTEM. THE USER NOTED TECHNICAL FAILURE ALARMS - #009 - TECHNICAL FAILURE, CONTROL PANEL (INTERNAL COMMUNICATION ERROR) AND #00B - TECHNICAL FAILURE, CONTROL PANEL (AUDIBLE ALARM MALFUNCTION). ADDITIONALLY, THE USER PROVIDED VIDEO OF THE SYSTEM POWERED ON WITH A BLANK SCREEN ON THE CONTROL PANEL AND AN AUDIBLE ALARM. THERE WAS NO PATIENT INVOLVEMENT. THE COMPLAINT SAMPLE WAS AVAILABLE FOR PRODUCT EVALUATION BUT NOT RETURNED TO THE MANUFACTURER FOR 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 THERE WERE REPEATED AND MULTIPLE TECHNICAL FAILURE ALARMS WHILE SETTING UP AND TESTING THE SYSTEM. THE USER NOTED TECHNICAL FAILURE ALARMS - #009 - TECHNICAL FAILURE, CONTROL PANEL (INTERNAL COMMUNICATION ERROR) AND #00B - TECHNICAL FAILURE, CONTROL PANEL (AUDIBLE ALARM MALFUNCTION). ADDITIONALLY, THE USER PROVIDED VIDEO OF THE SYSTEM POWERED ON WITH A BLANK SCREEN ON THE CONTROL PANEL AND AN AUDIBLE ALARM. THERE WAS NO PATIENT INVOLVEMENT. THE COMPLAINT SAMPLE WAS AVAILABLE FOR PRODUCT EVALUATION.