BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LUNGFIT PH

    MDR report key: 21850900 · Received April 16, 2025

    Report

    Report Number
    MW5169142
    Event Type
    Malfunction
    Date Received
    April 16, 2025
    Date of Event
    March 30, 2025
    Report Date
    April 10, 2025
    Manufacturer
    BEYOND AIR INC.
    Product Code
    QTB
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    FL, US
    Reporter Occupation
    RISK MANAGER
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    BEYOND AIR MACHINE WAS ALARMING "MAIN DELIVERY FAILURE." MACHINE SWITCHED INTO BACKUP MODE AND SWAPPED OUT WITH ALTERNATE MACHINE. VITAL SIGNS WERE STABLE BEFORE, DURING, AND AFTER TRANSFER TO NEW MACHINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    134370 LUNGFIT PH NITRIC OXIDE GENERATOR AND DELIVERY SYSTEM QTB BEYOND AIR INC. 90002

    Patients

    Seq Age Sex Outcome Treatment
    1 1 MO Female