BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AERONOX 2.0

    MDR report key: 9106492 · Received September 23, 2019

    Report

    Report Number
    MW5089979
    Event Type
    Malfunction
    Date Received
    September 23, 2019
    Date of Event
    September 4, 2019
    Report Date
    September 19, 2019
    Manufacturer
    INTERNATIONAL BIOMEDICAL LTD.
    Product Code
    MRN
    UDI-DI
    08656480003370
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    IN, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    AERONOX 2.0 DEVICE WAS POWERED ON DURING DELIVERY OF NITRIC OXIDE. UPON ARRIVAL TO THE HOSPITAL STEPS AWAY FROM THE NEONATAL ICU THE DEVICE WENT INTO A COMPLETE POWER FAILURE WHICH STOPPED THE NITRIC OXIDE ADMINISTRATION IMMEDIATELY. THE DEVICE PLUGGED INTO WALL POWER AND RESTARTED WITHIN A FEW MINUTES TO RESTART THE ADMINISTRATION. THERE ARE THREE ISSUES; IT HAS BEEN DETERMINED THE LEAD ACID BATTERY DOES NOT HOLD A FULL CHARGE AFTER A COMPLETE POWER DRAIN. THE LEAD ACID BATTERY IS CAPABLE OF 50% CAPACITY AFTERWARDS. AFTER SPEAKING WITH THE INTERNATIONAL BIOMEDICAL TECHNICAL SUPPORT THEY ARE UNABLE TO PROVIDE A LITHIUM ION BATTERY WHICH WOULD RESOLVE THE ISSUE; THE POWER CORD FROM THE WALL TO THE UNIT IS NOT SECURE. THE BIOMEDICAL SERVICES AT OUR FACILITY WAS ABLE TO PLACE A CORD RETAINER TO SECURE THE CORD. WHEN THE UNIT IS PLUGGED INTO THE WALL POWER IT IS ONLY CHARGING THE BATTERY NOT POWERING THE UNIT. THEREFORE IT IS IMPOSSIBLE TO KNOW THE DURATION BATTERY LIFE AND THE UNIT UTILIZES THE BATTERY POWER FASTER THAN THE CHARGING CAPABILITY.; IT IS IMPOSSIBLE TO KNOW THE AMOUNT OF TIME THE LEAD ACID BATTERY HAS LEFT ONCE THE UNIT POWERED ON. THREE OF OUR DEVICES WERE TURNED ON WITHOUT USE AND ONE HAD A FEW MINUTES, THE SECOND HAD 28 MINUTES AND THE LAST ONE WAS ONE HOUR AND EIGHT MINUTES. FDA SAFETY REPORT ID # (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    896273 AERONOX 2.0 APPARATUS, NITRIC OXIDE MRN INTERNATIONAL BIOMEDICAL LTD. 731-9159 IP33 08656480003370
    896274 AERONOX 2.0 APPARATUS, NITRIC OXIDE MRN INTERNATIONAL BIOMEDICAL LTD.
    896275 AERONOX 2.0 APPARATUS, NITRIC OXIDE MRN INTERNATIONAL BIOMEDICAL LTD.

    Patients

    Seq Age Sex Outcome Treatment
    1 0 DA