BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VIOS LC AEROSOL DELIV SYST

    MDR report key: 23276113 · Received October 14, 2025

    Report

    Report Number
    MW5177229
    Event Type
    Malfunction
    Date Received
    October 14, 2025
    Report Date
    October 8, 2025
    Manufacturer
    PARI RESPIRATORY EQUIPMENT, INC.
    Product Code
    CAF
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    US
    Reporter Occupation
    003
    Health Professional
    N

    Narratives

    Description of Event or Problem · 0

    PATIENT REPORTS VIOS LC AEROSOL NOT WORKING, IT ONLY HUMS. PT IS JUST STARTING MEDICATION, UNKNOWN IF AN ADVERSE EVENT OCCURRED, UNKNOWN IF DEFECTIVE DEVICE IS ON HAND FOR INDICATION: CHRONIC OBSTRUCTIVE PULMONARY DISEASE, UNSPECIFIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    198869 VIOS LC AEROSOL DELIV SYST NEBULIZER (DIRECT PATIENT INTERFACE) CAF PARI RESPIRATORY EQUIPMENT, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male OHTUVAYRE INH SUSP