BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NOXBOX INHALED NITRIC OXIDE DELIVERY SYSTEM

    MDR report key: 19730693 · Received July 11, 2024

    Report

    Report Number
    MW5157242
    Event Type
    Injury
    Date Received
    July 11, 2024
    Date of Event
    July 7, 2024
    Report Date
    July 10, 2024
    Manufacturer
    PRAXAIR/LINDE GAS & EQUIPMENT INC.
    Product Code
    MRP
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NV, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    PRAXAIR/LINDE NOXBOX INHALED NITRIC OXIDE SYSTEM EXPERIENCING SWINGS IN DELIVERED INHALED NITRIC OXIDE WHEN USED WITH HIGH FREQUENCY JET VENTILATOR (HFJV). THE HFJV HAD TO HAVE SETTINGS MANIPULATED IN ORDER TO BALANCE AND STABILIZE THE DESIRED PARTS PER MILLION (PPM) OF INHALED NITRIC OXIDE. HAVE HAD SIMILAR EXPERIENCES WHEN THE NOXBOX IS USED WITH HIGH FREQUENCY OSCILLATOR VENTILATOR (HFOV). PRAXAIR HAS BEEN MADE AWARE OF THE ISSUE AND IS UNABLE TO PROVIDE DIRECTION TO CORRECT THE SITUATION OTHER THAN TO INDICATE MANIPULATING VENTILATOR SETTINGS. THIS IS OCCURRING IN THE NEONATAL INTENSIVE CARE UNIT (NICU), WHERE PRECISE VENTILATOR SETTINGS ARE REQUIRED AND EVEN THE SLIGHTEST VARIATION IN SETTINGS CAN HAVE SIGNIFICANT IMPACT ON THE PATIENT CARE. PRAXAIR/LINDE, DANBURY, CT 06810 US.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1269597 NOXBOX INHALED NITRIC OXIDE DELIVERY SYSTEM ANALYZER, NITRIC OXIDE MRP PRAXAIR/LINDE GAS & EQUIPMENT INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 5 MO Prefer Not To Disclose Required Intervention