BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEBULIZER PARI PLUS LC

    MDR report key: 23647534 · Received November 25, 2025

    Report

    Report Number
    MW5179425
    Event Type
    Malfunction
    Date Received
    November 25, 2025
    Report Date
    November 21, 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 HIS NEBULIZER IS NOT WORKING. HE WASHED IT 3 TIMES WITH HOT WATER AND IT IS STILL NOT DISPENSING MEDICATION CORRECTLY. HE REPORTED THAT HE HAS GOOD AIRFLOW THROUGH THE TUBING OF NEBULIZER, BUT AIRFLOW IS LESS THAN NORMAL AT THE NEBULIZER. UNKNOWN WHEN PROBLEM WITH DISPENSING BECAME A PROBLEM. PATIENT WAS SENT A REPLACEMENT NEBULIZER. UNKNOWN IF MISSED DOSE OCCURRED. NO ADVERSE EVENT REPORTED. UNKNOWN IF AVAILABLE FOR RETURN. NO FURTHER INFORMATION PROVIDED. UNKNOWN IF MD IS AWARE. NO ADDITIONAL INFORMATION AVAILABLE. INDICATION: CHRONIC OBSTRUCTIVE PULMONARY DISEASE, UNSPECIFIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1948107 NEBULIZER PARI PLUS LC NEBULIZER (DIRECT PATIENT INTERFACE) CAF PARI RESPIRATORY EQUIPMENT, INC. 250613

    Patients

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