BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AERONOX NITRIC OXIDE DELIVERY DEVICE

    MDR report key: 10553032 · Received September 18, 2020

    Report

    Report Number
    10553032
    Event Type
    Malfunction
    Date Received
    September 18, 2020
    Date of Event
    August 24, 2020
    Report Date
    September 10, 2020
    Manufacturer
    INTERNATIONAL BIOMEDICAL, LTD.
    Product Code
    MRN
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    UT
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 0

    (B)(6) RN NOTE: NITRIC 2.0 WOULD NOT CHARGE PLUGGED INTO THE ISOLETTE. THIS WAS NOT NOTICED UNTIL WE WERE IN THE AIR AND THE OTHER CORD WAS IN THE TAIL. ROUGHLY 5 MINUTES FROM LANDING, THE NITRIC MACHINE STOPPED READING. BAGGER WAS SET UP AND READY TO GO. PATIENT BAGGED AND TOLERATED BAGGING WELL. ONCE HELICOPTER LANDED AT THE HOSPITAL, GRABBED PLUG FROM TAIL AND ATTEMPTED TO USE THAT, BUT IT WOULD NOT CHARGE EITHER. PATIENT BAGGED TO NICU AND PLACED ON THEIR EQUIPMENT. CLINICAL ENGINEERING CAME TO NICU AND LOOKED AT THE EQUIPMENT. THEY FOUND THAT THE MIDDLE PART OF THE NORMAL PLUG WAS LOOSE AND THAT IS WHY IT WOULD NOT CHARGE WITH THAT. THE ISOLETTE PLUG HAD POWER, BUT WOULD ONLY CHARGE WHEN HELD IT JUST RIGHT. PATIENT WAS ALREADY VERY SICK SO IT IS UNKNOWN IF THE MALFUNCTION CAUSED MORE HARM TO THE PATIENT DUE TO ALTERNATIVE MEASURES. CLINICAL ENGINEERING NOTE: DC INPUT JACK ON REAR OF AERONOX DOES NOT HOLD CABLE CONNECTOR TIGHTLY, THE CABLE CAN FALL OUT. THE CHARGER WAS CARRIED ON THE TRANSPORT AND THE POWER CORD WAS NOT CONNECTED TIGHTLY TO THE CHARGER SO THAT WHEN THE ATTEMPT WAS MADE TO POWER THE AERONOX FROM THE CHARGER AFTER THE BATTERY FAILED, THERE WAS NO POWER FROM THE CHARGER. THE CONNECTOR ON THE CABLE THAT POWERS THE AERONOX FROM THE INCUBATOR ALSO FAILED DUE TO PROBLEMS OF FIT AND LOOSENESS. THIS CAUSED THE AERONOX TO BE RUNNING ON ITS INTERNAL BATTERY EVEN THOUGH THE CONNECTOR WAS CONNECTED. CLINICAL ENGINEER MADE TEMPORARY RESOLUTION TO DC POWER INPUT CONFIGURATION TO ASSURE CONNECTION. THERE HAVE BEEN SIMILAR EVENTS IN THE PAST.

    Description of Event or Problem · 1

    LIFE FLIGHT RN NOTE: NITRIC 2.0 WOULD NOT CHARGE PLUGGED INTO THE ISOLETTE. THIS WAS NOT NOTICED UNTIL WE WERE IN THE AIR AND THE OTHER CORD WAS IN THE TAIL. ROUGHLY 5 MINUTES FROM LANDING, THE NITRIC MACHINE STOPPED READING. BAGGER WAS SET UP AND READY TO GO. PATIENT BAGGED AND TOLERATED BAGGING WELL. ONCE HELICOPTER LANDED AT (B)(6), GRABBED PLUG FROM TAIL AND ATTEMPTED TO USE THAT, BUT IT WOULD NOT CHARGE EITHER. PATIENT BAGGED TO NICU AND PLACED ON THEIR EQUIPMENT. CLINICAL ENGINEERING CAME TO NICU AND LOOKED AT THE EQUIPMENT. THEY FOUND THAT THE MIDDLE PART OF THE NORMAL PLUG WAS LOOSE AND THAT IS WHY IT WOULD NOT CHARGE WITH THAT. THE ISOLETTE PLUG HAD POWER, BUT WOULD ONLY CHARGE WHEN HELD IT JUST RIGHT. PATIENT WAS ALREADY VERY SICK SO IT IS UNKNOWN IF THE MALFUNCTION CAUSED MORE HARM TO THE PATIENT DUE TO ALTERNATIVE MEASURES. CLINICAL ENGINEERING NOTE: DC INPUT JACK ON REAR OF AERONOX DOES NOT HOLD CABLE CONNECTOR TIGHTLY, THE CABLE CAN FALL OUT. THE CHARGER WAS CARRIED ON THE TRANSPORT AND THE POWER CORD WAS NOT CONNECTED TIGHTLY TO THE CHARGER SO THAT WHEN THE ATTEMPT WAS MADE TO POWER THE AERONOX FROM THE CHARGER AFTER THE BATTERY FAILED, THERE WAS NO POWER FROM THE CHARGER. THE CONNECTOR ON THE CABLE THAT POWERS THE AERONOX FROM THE INCUBATOR ALSO FAILED DUE TO PROBLEMS OF FIT AND LOOSENESS. THIS CAUSED THE AERONOX TO BE RUNNING ON ITS INTERNAL BATTERY EVEN THOUGH THE CONNECTOR WAS CONNECTED. CLINICAL ENGINEER MADE TEMPORARY RESOLUTION TO DC POWER INPUT CONFIGURATION TO ASSURE CONNECTION. THERE HAVE BEEN SIMILAR EVENTS IN THE PAST.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1019905 AERONOX NITRIC OXIDE DELIVERY DEVICE APPARATUS, NITRIC OXIDE DELIVERY MRN INTERNATIONAL BIOMEDICAL, LTD. AERONOX X-143

    Patients

    Seq Age Sex Outcome Treatment
    1