INTELLIOX PLUS
Received Sep 18, 2023 · Event occurred Aug 14, 2023
Report 3003764448-2023-00002 · MDR key 17764160
Device
Generic name
Gas Regulator
Manufacturer
RotarexProduct problems
- Gas Output Problem
- Gas Output Problem
Patient
Unknown
- Unspecified Respiratory Problem
- Unspecified Respiratory Problem
Narrative
Additional Manufacturer Narrative
FDA MW5144785.
Description of Event or Problem
PATIENT WAS PLACED ON 6L HIGH FLOW ON THE PORTABLE TANK. DURING TRANSPORT, TRANSPORT STAFF FLAGGED DOWN NURSING STAFF AS PATIENT WAS BECOMING LESS RESPONSIVE AND DISKY IN COLOR ENROUTE. PATIENT PUT ON MONITOR SHOWING DESATURATION. SWITCHED TO WALL O2 AND PUT ON FACE MASK. PATIENT'S OXYGENATION QUICKLY IMPROVED. IT WAS NOTED THAT THE PORTABLE O2 TANK WAS SHOWING FULL BUT NO O2 IS COMING OUT, NO MATTER HOW MANY LITERS IT IS SET TO. DEVICE WAS TAKEN OUT OF SERVICE. ALTHOUGH MALFUNCTION HAS BEEN PROPOSED BY USER, THE DEVICE HAS NOT BEEN RETURNED TO MANUFACTURER FOR INSPECTION.