BEUDAMED
    FDA Adverse Event Summary report: N

    FLEX2

    MDR report key: 3001555 · Received February 10, 2013

    Report

    Report Number
    3001555
    Date Received
    February 10, 2013
    Date of Event
    December 3, 2012
    Report Date
    February 8, 2013
    Manufacturer
    KING SYSTEMS CORPORATION
    Product Code
    CAI
    Report Source
    User Facility report
    Reporter Location
    MI, US

    Narratives

    Description of Event or Problem · 1

    A COAXIAL ANESTHESIA CIRCUIT WAS SET UP IMPROPERLY, UNRECOGNIZED BY THE ANESTHESIA TECH AND THE PROVIDER. APPROPRIATE MEASURES WERE TAKEN TO PREVENT PATIENT HARM (VENTILATION BY BAG/MASK, CONVERSION TO AN ORDINARY CIRCUIT). PART OF THE CONFUSION IS LIKELY DUE TO THE CONVERSION FROM ANOTHER VENDOR'S PURPLE COAXIAL CIRCUITS TO THIS BLUE COAXIAL CIRCUIT.WHAT WAS THE ORIGINAL INTENDED PROCEDURE?ANESTHESIA FOR A RADIOLOGY PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    57992 FLEX2 BREATHING CIRCUIT, ANESTHESIA CAI KING SYSTEMS CORPORATION * IZ9X5

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR