BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNIVERSAL FLEX 2 BREATHING CIRCUIT

    MDR report key: 1079819 · Received July 17, 2008

    Report

    Report Number
    1824226-2008-00002
    Event Type
    Malfunction
    Date Received
    July 17, 2008
    Date of Event
    July 2, 2008
    Report Date
    July 15, 2008
    Manufacturer
    KING SYSTEMS CORP.
    Product Code
    CAI
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SD, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    KING SYSTEMS INVESTIGATION SUMMARY OF RETURNED PRODUCT: RETURNED DEVICE WAS RECEIVED 07/03/08. THE REVIEW OF THE RETURNED SAMPLE, CONFIRMED THAT, AT THE END OF THE INNER TUBE CONNECTED TO THE MACHINE END (F2 FILTER END), THERE WAS A BREAK IN THE INNER TUBE (15MM PURPLE TUBE) AT THE SIXTH CORRUGATE. THE BREAK IN THE TUBING WAS CLEAN (IN THAT THE PURPLE TUBE WAS IN TWO PIECES).

    Description of Event or Problem · 1

    REPORTED TO KING SYSTEMS IN 2008: AS STATED IN COMPLAINT RECEIVED FROM USER FACILITY: LAST EVENING ONE OF THE STAFF DID AN INDUCTION AND THEN KEPT GETTING HIGH ETCO2 ALARMS AND WASN'T ABLE TO DELIVER THE SET TIDAL VOLUME. THE CO2 KEPT CLIMBING AND THEN THEY NOTICED THE PURPLE INNER TUBING OF THE CIRCUIT WAS IN TWO PIECES LIKE IT HAD BEEN CUT. CIRCUITS SWITCHED AND EVERYTHING RETURNED TO NORMAL. THEY DISCOVERED THE PROBLEM BEFORE THERE WAS ANY PATIENT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNIVERSAL FLEX 2 BREATHING CIRCUIT FLEX 2 CIRCUIT CAI KING SYSTEMS CORP. NA IKVB5

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention