BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AIR LIFE NEO-VERSO "Y" AIRWAY ACCESS ADAPTER

    MDR report key: 2809957 · Received October 19, 2012

    Report

    Report Number
    2809957
    Event Type
    Malfunction
    Date Received
    October 19, 2012
    Date of Event
    September 21, 2012
    Report Date
    October 18, 2012
    Manufacturer
    CAREFUSION
    Product Code
    BZA
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    NY, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    ETT AIRWAY ADAPTOR BECAME DISCONNECTED FROM VENT, CAUSING PT TO BE DISCONNECTED FROM VENTILATOR. IT WAS DISCOVERED THAT THE ETT SIZE ADAPTOR WAS NOT TIGHTLY CONNECTED TO THE "Y" ADAPTER. WHEN THE NURSE WENT TO RE-CONNECT IT WAS NOTED THAT A SMALL CLEAR RUBBER RING THAT HAD FALLEN OFF THE ADAPTER WAS NOTED TO BE IN THE ETT. THE ADAPTER WAS REMOVED AND A NEW DEVICE ASSEMBLED AND ATTACHED. THERE WAS NO HARM TO THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AIR LIFE NEO-VERSO "Y" AIRWAY ACCESS ADAPTER NONE BZA CAREFUSION

    Patients

    Seq Age Sex Outcome Treatment
    1 Other