BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DOUBLE SWIVEL ELBOW WITH 9.5 MM PORT

    MDR report key: 1365337 · Received April 15, 2009

    Report

    Report Number
    MW5010807
    Event Type
    Injury
    Date Received
    April 15, 2009
    Date of Event
    February 7, 2009
    Report Date
    April 15, 2009
    Manufacturer
    INTERSURGICAL INC.
    Product Code
    BZO
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    OR, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THIS PATIENT WAS TRANSFERRED FROM A HOSPITAL TO A FACILITY POST CARDIAC ARREST. OUR AMBULANCE SERVICE USED A PORTABLE VENTILATOR DURING THE TRANSPORT. UPON ARRIVAL AT THE RECEIVING HOSPITAL, IT WAS NOTED THAT THE FLIP-CAP LID ON THE SWIVEL ELBOW USED BETWEEN THE VENTILATION CIRCUIT AND THE ENDOTRACHEAL TUBE WAS OPEN. THIS LID IS DESIGNED TO ALLOW FOR TRACHEAL SUCTIONING WITHOUT REMOVING THE VENTILATION CIRCUIT. WITH THIS LID OPEN, THE MAJORITY OF AIRFLOW BYPASSES THE PATIENT. IT MOST LIKELY OCCURRED DURING THE MOVEMENT OF THE PATIENT FROM THE BACK OF THE AMBULANCE INTO THE RECEIVING FACILITY. IT WAS NOTED BY OUR STAFF, AS WELL AS THE RESPIRATORY THERAPIST AT THE HOSPITAL, THAT THE FLIP-CAP STYLE LID USED OPENS TOO EASILY. A SIMPLE CATCH OF A CORD WILL POP THE DEVICE OPEN ALLOWING VENTILATIONS TO ESCAPE. WE FEEL THIS IS A POOR DESIGN. OUR SERVICE HAS REMOVED ALL OF THESE SWIVEL ELBOWS AND REPLACED THEM WITH A NON-SUCTION PORT STYLE. DATES OF USE: 2009. DIAGNOSIS: RESPIRATORY FAILURE. EVENT ABATED AFTER USE STOPPED: YES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DOUBLE SWIVEL ELBOW WITH 9.5 MM PORT SWIVEL ELBOW WITHSUCTION PORT BZO INTERSURGICAL INC. 1996-3-E 2071629

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Other| S