BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AIRLIFE INFANT COMFORT SOFT PLUS NASAL CANNULA

    MDR report key: 17912432 · Received October 10, 2023

    Report

    Report Number
    MW5146796
    Event Type
    Malfunction
    Date Received
    October 10, 2023
    Date of Event
    September 26, 2023
    Report Date
    October 6, 2023
    Manufacturer
    WESTMED, INC.
    Product Code
    CAT
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TX, US
    Reporter Occupation
    RISK MANAGER
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    NASAL CANNULA WAS ASSESSED AND TUBING WAS BLACK. VENDOR ITEM WM0187; LOT: UNKNOWN. AIRLIFE WESTMED INC. GRAND RAPIDS, MI 49544. US.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2115000 AIRLIFE INFANT COMFORT SOFT PLUS NASAL CANNULA CANNULA, NASAL, OXYGEN CAT WESTMED, INC. 0556

    Patients

    Seq Age Sex Outcome Treatment
    1 5 YR Male