BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLEX 2 CIRCUIT

    MDR report key: 3201969 · Received June 26, 2013

    Report

    Report Number
    1824226-2013-00001
    Event Type
    Malfunction
    Date Received
    June 26, 2013
    Date of Event
    May 6, 2013
    Report Date
    June 6, 2013
    Manufacturer
    KING SYSTEMS
    Product Code
    CAI
    PMA / PMN Number
    K880683
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    INNER TUBE OF COAXIAL ANESTHESIA CIRCUIT DETACHED RESULTING IN CO2 AND GASES BEING INHALED BY THE PT. THERE WERE NO NEGATIVE OBSERVABLE EFFECTS TO THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    290561 FLEX 2 CIRCUIT CIRCUIT, BREATHING W/CONNECTOR, ADAPTER CAI KING SYSTEMS CF070-61 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Other