BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VYAIRE MEDICAL, INC

    MDR report key: 19148747 · Received April 19, 2024

    Report

    Report Number
    8030673-2024-01004
    Event Type
    Malfunction
    Date Received
    April 19, 2024
    Date of Event
    March 20, 2024
    Report Date
    April 19, 2024
    Manufacturer
    VYAIRE MEDICAL
    Product Code
    BZA
    UDI-DI
    10190752147690
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE OBSTRUCTION OF AIRFLOW TO THE PATIENT WHEN THE ADPATER IS SPLITM OR COLLAPSES WOULD CAUSE A LOSS OF OXYGEN. THERE IS A POSSIBLITY OF THE SPLINTERING OF THE ADAPTER TO CAUSE SHARDS THAT PATIENT COULD INHALE. THIS WOULD DELAY PATIENT THERAPY OR VENTILATION

    Additional Manufacturer Narrative · 0

    THE OBSTRUCTION OF AIRFLOW TO THE PATIENT WHEN THE ADPATER IS SPLITM OR COLLAPSES WOULD CAUSE A LOSS OF OXYGEN. THERE IS A POSSIBLITY OF THE SPLINTERING OF THE ADAPTER TO CAUSE SHARDS THAT PATIENT COULD INHALE. THIS WOULD DELAY PATIENT THERAPY OR VENTILATION SINCE THE REPORTED DEFECT WAS NOT CONFIRMED AND THE ROOT CAUSE WAS NOT ESTABLISHED NO CORRECTIVE OR PREVENTIVE ACTIONS WERE TAKEN. HOWEVER, ASSEMBLY PERSONNEL WERE NOTIFIED ABOUT THE COMPLAINT.".

    Description of Event or Problem · 0

    ONCE THE PLASTIC COLLAPSES, THE AIRFLOW TO MY PATIENT IS PARTIALLY OBSCURED. THE PLASTIC ALSO LOOKS LIKE IT WILL START TO SPLINTER AND OPEN, WHICH COULD POTENTIALLY CAUSE MY PATIENT TO INHALE PLASTIC SHARDS.

    Description of Event or Problem · 0

    ONCE THE PLASTIC COLLAPSES, THE AIRFLOW TO MY PATIENT IS PARTIALLY OBSCURED. THE PLASTIC ALSO LOOKS LIKE IT WILL START TO SPLINTER AND OPEN, WHICH COULD POTENTIALLY CAUSE MY PATIENT TO INHALE PLASTIC SHARDS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1272394 VYAIRE MEDICAL, INC ADAPTER OMNIFLEX PEDIATRIC BZA VYAIRE MEDICAL 3215 0004256278 10190752147690

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other