BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VIOS LC AEROSOL DELIV SYST

    MDR report key: 23680125 · Received December 1, 2025

    Report

    Report Number
    MW5179572
    Event Type
    Malfunction
    Date Received
    December 1, 2025
    Report Date
    November 24, 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 REPORTED NEBULIZER MACHINE NOT WORKING PROPERLY. PATIENT STATED IT TAKES TOO LONG TO INHALE. IT SHOULD ONLY TAKE 5 TO 7 MINUTES FOR THE INHALATION TO COMPLETE. HOWEVER, IT IS TAKING 40-45 MINUTES. PROVIDED THE MANUFACTURER PHONE NUMBER FOR THE REPLACEMENT. MISSED DOSE REPORTED. NO ADVERSE EVENTS REPORTED. NO FURTHER INFORMATION PROVIDED. INDICATION: CHRONIC OBSTRUCTIVE PULMONARY DISEASE, UNSPECIFIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2400460 VIOS LC AEROSOL DELIV SYST NEBULIZER (DIRECT PATIENT INTERFACE) CAF PARI RESPIRATORY EQUIPMENT, INC. AD2514485

    Patients

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