AERONOX 2.0 NITRIC OXIDE TITRATION & MONITORING

Description of Event or Problem

ODOR IN PLANE COMING FROM A DIFFERENT AERONOX DEVICE, FOUR PERSONNEL BECAME ILL (HEADACHE, RESPIRATORY IRRITATION, LOSS OF CONSCIOUSNESS, REQUIRED TREATMENT. ONE PERSONNEL REQUIRED HOSPITALIZATION WITH CONTINUED RESPIRATORY ISSUES. NO PATIENT INVOLVED. DETAIL: THE AERONOX WAS PLUGGED IN TO KEEP BATTERY CHARGED BUT WAS NOT IN USE AT TIME OF EVENT. ALL UNITS WERE REMOVED FROM SERVICE. EVENT REPORTED TO MANUFACTURER. MANUFACTURER SENT EMAIL THEY WERE FILING WITH FDA BUT I CAN NOT FIND A REPORT IN THE FDA SYSTEM. UNITS WERE SENT TO ECRI FOR TESTING. ENGINEER CONDUCTED TESTING AND WAS UNABLE TO REPLICATE THE ODORS IN THE LAB SETTING. A REPORT WAS PROVIDED BY ECRI OF THE LAB TESTING AND RESULTS. ON-SITE TESTING CONNECTED TO THE ISOLETTE IS NOT POSSIBLE AT THIS IS TIME DUE TO COVID 19. FDA SAFETY REPORT ID# (B)(4).