BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNI-HEART¿ LO-FLO CONTINUOUS NEBULIZER

    MDR report key: 7925736 · Received October 2, 2018

    Report

    Report Number
    7925736
    Event Type
    Malfunction
    Date Received
    October 2, 2018
    Date of Event
    February 6, 2018
    Report Date
    March 12, 2018
    Manufacturer
    WESTMED, INC.
    Product Code
    CAF
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    THREE DIFFERENT UNIHEART LO-FLO CONTINUOUS NEBULIZER BUBBLING AND NOT NEBULIZING ALL FROM SAME LOT NUMBER 122617U21.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    766042 UNI-HEART¿ LO-FLO CONTINUOUS NEBULIZER NEBULIZER (DIRECT PATIENT INTERFACE) CAF WESTMED, INC. 100850 122617U21

    Patients

    Seq Age Sex Outcome Treatment
    1