BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COMFORT SOFT PLUS

    MDR report key: 2537585 · Received April 9, 2012

    Report

    Report Number
    2537585
    Event Type
    Malfunction
    Date Received
    April 9, 2012
    Date of Event
    March 22, 2012
    Report Date
    April 9, 2012
    Manufacturer
    WESTMED, INC.
    Product Code
    CAI
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    VA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    A NURSE THOUGHT THERE WAS SOMETHING WRONG WITH THE FLOW OF OXYGEN IN THE PATIENT ROOM BECAUSE THE FLOW METER WOULD NOT ALLOW HER TO INCREASE THE OXYGEN ABOVE 2 LITERS ON A PATIENT. AFTER INVESTIGATION OF THE OXYGEN FLOW, FLOW METER, AND NASAL CANNULA, IT WAS DISCOVERED THAT THE NASAL CANNULA INTERNAL LUMEN WAS NOT COMPLETELY OPEN. THIS CAUSED TOO MUCH PRESSURE TO BUILD UP AS THE OXYGEN FLOW RATE WAS INCREASED, CAUSING FAILURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COMFORT SOFT PLUS NASAL CANNULA CAI WESTMED, INC. * *

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR