BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AERONOX NITRIC OXIDE DELIVERY DEVICE

    MDR report key: 8748159 · Received July 1, 2019

    Report

    Report Number
    8748159
    Event Type
    Malfunction
    Date Received
    July 1, 2019
    Date of Event
    June 6, 2019
    Report Date
    June 10, 2019
    Manufacturer
    INTERNATIONAL BIOMEDICAL, LTD.
    Product Code
    MRN
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    FL
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    WHILE PREPARING TO TRANSPORT A PATIENT ON A HELICOPTER, WHILE TESTING THE UNIT BEFORE USE, IT TURNED OFF AFTER A COUPLE MINUTES OF BEING TURNED ON. THE DEVICE HAD A NEW BATTERY REPLACED ON (B)(6) 2019 AND IT WAS SERVICED BY THE MANUFACTURER ON (B)(6) 2018. THE UNIT WAS MAINTAINED ON A CHARGE CYCLE. UPON REVIEWING RECORDS, THERE HAS BEEN A COUPLE OF INSTANCES ON VARIOUS UNITS WITH THE SAME BATTERY ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    542395 AERONOX NITRIC OXIDE DELIVERY DEVICE APPARATUS, NITRIC OXIDE DELIVERY MRN INTERNATIONAL BIOMEDICAL, LTD. AERONOX

    Patients

    Seq Age Sex Outcome Treatment
    1