BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VERSO AIRWAY ACCESS ADAPTER

    MDR report key: 1649635 · Received March 19, 2010

    Report

    Report Number
    1649635
    Event Type
    Malfunction
    Date Received
    March 19, 2010
    Date of Event
    March 10, 2010
    Report Date
    March 19, 2010
    Manufacturer
    CAREFUSION AIRLIFE
    Product Code
    BZA
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MD, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PT IN ICU ON VENTILATOR. WHILE PATIENT WAS BEING TURNED THE NURSE HEARD AIR LEAK. THE VERSO ADAPTER HAD SNAPPED IN TWO AND PART OF IT REMAINED IN THE PATIENT. THE PT. BECAME DISCONNECTED FROM THE VENTILATOR. ONE NURSE HELD ON TO THE ADAPTER AND KEEPING INLINE SUCTION TOGETHER WHILE ANOTHER WAS USING AMBU BAG TO VENTILATE PATIENT. PIECE WAS REMOVED FROM PATIENT'S THROAT WITH FORCEPS WITHOUT INJURY. INLINE SUCTION WAS REPLACED.====================== HEALTH PROFESSIONAL'S IMPRESSION======================NO ADVERSE EVENT. INLINE ADAPTER SNAPPED, OPENING THE CLOSED SYSTEM====================== MANUFACTURER RESPONSE FOR ADAPTER FOR VENTILATOR INLINE SUCTION, VERSO AIRWAY ACCESS ADAPTER======================"WE HAVE HAD ONLY ONE VERSO SNAP BEFORE..."IT WAS TESTED AND APPEARED FINE. MAKING SEVERAL MODIFICATIONS TO DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VERSO AIRWAY ACCESS ADAPTER ADAPTER FOR VENTILATOR INLINE SUCTION BZA CAREFUSION AIRLIFE CE0086 09060014

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR OTHER