BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HUDSON RCI

    MDR report key: 14914163 · Received July 5, 2022

    Report

    Report Number
    14914163
    Event Type
    Malfunction
    Date Received
    July 5, 2022
    Date of Event
    June 1, 2022
    Report Date
    June 24, 2022
    Manufacturer
    TELEFLEX INCORPORATED
    Product Code
    CAF
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CT
    Reporter Occupation
    RISK MANAGER
    Health Professional
    N

    Narratives

    Description of Event or Problem · 0

    HUDSON RCI NEBULIZER BECAME DETACHED INTERNALLY FROM THE FLOW METER, WHICH WAS NOT OBVIOUSLY VISIBLE. PATIENT BEGAN TO DESATURATE, AND EQUIPMENT WAS TEMPORARILY FIXED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1449894 HUDSON RCI NEBULIZER (DIRECT PATIENT INTERFACE) CAF TELEFLEX INCORPORATED

    Patients

    Seq Age Sex Outcome Treatment
    1 27010 DA Female