Novalung console (Linux Board)
Received Jun 25, 2026 · Event occurred Jun 10, 2026
Report 3012172416-2026-00054 · MDR key 25619011
Device
Generic name
Extracorporeal System For Long-term Respiratory / Cardiopulmonary Failure
Manufacturer
Xenios AgCatalog number
F30000162
Product problems
- Incorrect, Inadequate or Imprecise Result or Readings
- Output Problem
- Insufficient Device Problem Information
Patient
Unknown
- 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 DURING SEVERAL PAST EXTRACORPOREAL MEMBRANE OXYGENATION SUPPORT RUNS, THE USER NOTICED AIR ALARMS THAT HE COULD NOT EXPLAIN TO HIMSELF. THESE ALARMS OCCURRED DURING THE START OF SUPPORT AND DISAPPEARED LATER ON. THE USER EXPLAINED THAT THEY CLEANED THE SENSOR AND HAS NOT USED ULTRASOUND GEL OR THE LIKE. THE USER HAS NOT STATED INDIVIDUAL DATES FOR THESE OCCURRENCES. THERE WAS NO INDICATION OF PATIENT SERIOUS INJURY. THE COMPLAINT SAMPLE WAS AVAILABLE FOR PRODUCT INVESTIGATION.