BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VIOS LC AEROSOL DELIV SYST

    MDR report key: 24617021 · Received March 17, 2026

    Report

    Report Number
    MW5185284
    Event Type
    Malfunction
    Date Received
    March 17, 2026
    Report Date
    March 12, 2026
    Manufacturer
    PARI RESPIRATORY EQUIPMENT, INC.
    Product Code
    CAF
    UDI-DI
    83490031067
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    N

    Narratives

    Description of Event or Problem · 0

    PATIENT REPORTED THERE'S NO MIST AND DOESN'T THINK MEDICATION IS BEING ADMINISTERED. UNKNOWN IF MISSED DOSE OCCURRED. NO ADVERSE EVENT REPORTED. UNKNOWN IF AVAILABLE FOR RETURN. NO FURTHER INFORMATION PROVIDED. INDICATION: CHRONIC OBSTRUCTIVE PULMONARY DISEASE, UNSPECIFIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    551332 VIOS LC AEROSOL DELIV SYST NEBULIZER (DIRECT PATIENT INTERFACE) CAF PARI RESPIRATORY EQUIPMENT, INC. 83490031067

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male OHTUVAYRE INH SUSP.