BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MINI-HEART®

    MDR report key: 19905355 · Received August 5, 2024

    Report

    Report Number
    19905355
    Event Type
    Malfunction
    Date Received
    August 5, 2024
    Date of Event
    May 28, 2024
    Report Date
    June 3, 2024
    Manufacturer
    WESTMED, INC.
    Product Code
    CAF
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    UT
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    HEALTHCARE PROVIDER FOUND THAT MINIHEART HI-FLO COMPRESSOR NEBULIZER SYSTEMS LOT 447757 ARE NOT NEBULIZING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1844762 MINI-HEART® NEBULIZER (DIRECT PATIENT INTERFACE) CAF WESTMED, INC. 100612 447757

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown