BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COMFORT SOFT PLUS

    MDR report key: 2968390 · Received February 13, 2013

    Report

    Report Number
    2968390
    Event Type
    Malfunction
    Date Received
    February 13, 2013
    Date of Event
    February 7, 2013
    Report Date
    February 13, 2013
    Manufacturer
    WESTMED, INC.
    Product Code
    CAT
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    IL, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    INFANT NOTED TO BE DESATURATING. INFANT REPOSITIONED AND WHEN INFANT TURNED OVER, THE NASAL CANNULA NOTED TO BE BROKEN AT CONNECTION. CANNULA CHANGED TO STANDARD INFANT CANNULA AND INFANT'S SATS REMAINED WITHIN NORMAL LIMITS. NO HARM TO INFANT.WHAT WAS THE ORIGINAL INTENDED PROCEDURE?OXYGEN ADMINISTRATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    62325 COMFORT SOFT PLUS NASAL CANNULA, INFANT CAT WESTMED, INC. * 04202012N04

    Patients

    Seq Age Sex Outcome Treatment
    1 *