BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VIOS LC AEROSOL DELIV SYST

    MDR report key: 23348508 · Received October 21, 2025

    Report

    Report Number
    MW5177695
    Event Type
    Malfunction
    Date Received
    October 21, 2025
    Report Date
    October 16, 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 NEBULIZATION MACHINE IS NOT WORKING PROPERLY. UNKNOWN WHAT TYPE OF DEFECT MACHINE HAS AS NO SPECIFICS WERE PROVIDED. UNKNOWN IF MD IS AWARE. NO FURTHER INFORMATION PROVIDED. UNKNOWN IF PATIENT MISSED DOSE. UNKNOWN IF PATIENT EXPERIENCED ANY ADVERSE EVENTS. UNKNOWN IF PRODUCT IS AVAILABLE FOR RETURN. UNKNOWN IF MD AWARE. NO FURTHER INFORMATION, DETAILS, OR DATES AVAILABLE. DIAGNOSIS FOR USE: CHRONIC OBSTRUCTIVE PULMONARY DISEASE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    242162 VIOS LC AEROSOL DELIV SYST NEBULIZER (DIRECT PATIENT INTERFACE) CAF PARI RESPIRATORY EQUIPMENT, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female OHTUVAYRE INH SUSP