BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BREATHING CIRCUIT

    MDR report key: 7409751 · Received April 9, 2018

    Report

    Report Number
    1319447-2018-00002
    Event Type
    Malfunction
    Date Received
    April 9, 2018
    Report Date
    April 9, 2018
    Manufacturer
    INTERSURGICAL INC.
    Product Code
    CAI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    RESPIRATORY THERAPIST

    Narratives

    Additional Manufacturer Narrative · 1

    DURING USAGE THE EXHALATION VENT MAY BECOME COVERED OR BLOCKED WHEN ASSEMBLING HME OR FILTER ON THE CONNECTOR. IN PLACING THE HME OR FILTER ON THE CONNECTOR THE TUBING MAY BE PUSHED UP THE CONNECTOR. THIS FORCE WOULD OVERCOME THE TUBING/ CONNECTOR INTERFERENCE FIT AND ALLOWED THE TUBE TO MOVE. THIS COULD POTENTIALLY COVER THE EXHALATION PORT. THERE WERE NO PATIENT ISSUES REPORTED DURING THIS EVALUATION. THE INSTRUCTIONS FOR USE PROVIDE SAFE AND EFFECTIVE DIRECTIONS. THE INSTRUCTIONS FOR USE STATE "WHEN ASSEMBLING ANY CONNECTORS USE A PUSH AND TWIST ACTION TO ENSURE A SECURE FIT". IT ALSO STATES DURING SET UP "SECURE ALL CONNECTIONS, PRESSURIZE DEVICE AND CHECK FOR LEAKAGE AND BLOCKAGE PRIOR TO USE". THERE WERE NO PATIENT ISSUES REPORTED DURING THIS USAGE.

    Description of Event or Problem · 1

    DURING USAGE THE EXHALATION VENT MAY BECOME COVERED OR BLOCKED WHEN ASSEMBLING HME OR FILTER ON THE CONNECTOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    248782 BREATHING CIRCUIT BREATHING CIRCUIT CAI INTERSURGICAL INC. B0062000

    Patients

    Seq Age Sex Outcome Treatment
    1