AERONOX 2.0 NITRIC OXIDE TITRATION & MONITORING

Description of Event or Problem

ODOR IN PLANE COMING FROM AERONOX 2.0 DEVICE, STAFF BECAME ILL (HEADACHE, RESPIRATORY IRRITATION, REQUIRED TREATMENT. DETAIL: THE AERONOX WAS PLUGGED IN TO KEEP BATTERY CHARGED BUT WAS NOT IN USE AT TIME OF EVENT. IN ROUTE, THREE PERSONNEL RN/RT/PILOT REPORTED HEADACHES. WHEN LOADING THE PATIENT, AN ODOR WAS DETECTED. DURING THE RETURN TRIP, THE ODOR WAS MORE PRONOUNCED AND THE RN AND RT GOT NAUSEOUS AND HAD DIFFICULTY BREATHING. OXYGEN WAS DEPLOYED. UPON ARRIVAL AT THE HOSPITAL, THE RN AND RT WERE SHOWING SIGNS CONSISTENT WITH FUME EXPOSURE AND RECEIVED TREATMENT. THE PATIENT WAS NOT HARMED. PLANE TESTED NO FINDINGS. DEVICE INTERNALLY TESTED WITH NO FINDINGS. REPORTED TO MANUFACTURER. UNIT WAS SENT TO MANUFACTURER WHO TESTED IT WITH NO FINDINGS. UNIT WAS PUT BACK IN SERVICE AND ON (B)(6) 2020 ODOR WAS DETECTED FROM SAME UNIT. UNIT WAS REMOVED FROM SERVICE. ODOR WAS REPLICATED DURING INTERNAL TESTING ON (B)(6) 2020 CONNECTED TO ISOLETTE UNIT INSIDE OF AMBULANCE. FDA SAFETY REPORT ID # (B)(4).