BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AERONOX 2.0 NITRIC OXIDE TITRATION & MONITORING

    MDR report key: 10835603 · Received November 13, 2020

    Report

    Report Number
    MW5097818
    Event Type
    Injury
    Date Received
    November 13, 2020
    Date of Event
    June 17, 2020
    Report Date
    November 9, 2020
    Manufacturer
    INTERNATIONAL BIOMEDICAL LTD.
    Product Code
    MRN
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TX, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    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).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1301829 AERONOX 2.0 NITRIC OXIDE TITRATION & MONITORING APPARATUS, NITRIC OXIDE DELIVERY MRN INTERNATIONAL BIOMEDICAL LTD. AERONOX 2.0

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR Hospitalization| L