BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFANT DUAL HEATED EVAQUA2 BREATHING CIRCUIT

    MDR report key: 3882174 · Received June 18, 2014

    Report

    Report Number
    9611451-2014-00518
    Event Type
    Malfunction
    Date Received
    June 18, 2014
    Date of Event
    May 9, 2014
    Report Date
    May 19, 2014
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LTD
    Product Code
    BZE
    PMA / PMN Number
    K103767
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE COMPLAINT RT266 INFANT EVAQUA2 BREATHING CIRCUIT IS EN ROUTE TO FISHER & PAYKEL HEALTHCARE (B)(4) FOR EVALUATION. A FOLLOW UP REPORT WILL BE PROVIDED UPON COMPLETION OF OUR INVESTIGATION.

    Additional Manufacturer Narrative · 1

    (B)(4). THE COMPLAINT RT266 INFANT EVAQUA2 BREATHING CIRCUIT IS EN ROUTE TO FISHER & PAYKEL HEALTHCARE (B)(4) FOR EVALUATION. A FOLLOW UP REPORT WILL BE PROVIDED UPON COMPLETION OF OUR INVESTIGATION. CORRECTION: THIS COMPLAINT DID NOT INVOLVE AN ADVERSE EVENT AND NO MEDICAL INTERVENTION WAS REQUIRED.

    Additional Manufacturer Narrative · 1

    (B)(4). THE COMPLAINT RT266 INFANT DUAL HEATED EVAQUA2 BREATHING CIRCUIT WAS NOT RETURNED TO FISHER AND PAYKEL HEALTHCARE IN (B)(4) FOR EVALUATION. DESPITE REQUESTS FOR THE RETURN OF THE RT266 BREATHING CIRCUIT THE DEVICE WILL NOT BE RETURNING FOR INVESTIGATION. THEREFORE, OUR INVESTIGATION IS BASED ON THE EVENT DESCRIPTION AND OUR KNOWLEDGE OF THE PRODUCT. THE HOSPITAL HAS CONFIRMED THAT THE SUBJECT BREATHING CIRCUIT WAS IN USE WHEN THE DISCONNECTION ISSUE WAS FIRST NOTICED. THEY HAVE SINCE CONFIRMED THAT THE PROBE BECOMING DISCONNECTED WAS CAUSED BY USER ERROR, AS OPPOSED TO A PRODUCT PROBLEM. ALL RT266 BREATHING CIRCUITS ARE PRESSURE TESTED BEFORE LEAVING THE PRODUCTION LINE AND THOSE THAT FAIL ARE DISCARDED. THE USER INSTRUCTIONS THAT ACCOMPANY THE RT266 INFANT DUAL HEATED EVAQUA2 BREATHING CIRCUIT STATE THE FOLLOWING: - "CHECK ALL CONNECTIONS ARE TIGHT BEFORE USE." - "PERFORM A PRESSURE AND LEAK TEST ON THE BREATHING SYSTEM AND CHECK FOR OCCLUSION BEFORE CONNECTING TO A PATIENT." - "SET APPROPRIATE VENTILATOR ALARMS."

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED VIA A FISHER & PAYKEL HEALTHCARE REPRESENTATIVE THAT TWO RT265 INFANT BREATHING CIRCUIT KIT TEMPERATURE PROBES BECAME DISCONNECTED FROM THE PATIENT END. NO PATIENT CONSEQUENCE WAS REPORTED.

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED VIA A FISHER & PAYKEL HEALTHCARE REPRESENTATIVE THAT TWO RT265 INFANT BREATHING CIRCUIT KIT TEMPERATURE PROBES BECAME DISCONNECTED FROM THE PATIENT END. NO PATIENT CONSEQUENCE WAS REPORTED. CORRECTION: THIS COMPLAINT DID NOT INVOLVE AN ADVERSE EVENT AND NO MEDICAL INTERVENTION WAS REQUIRED.

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED VIA A FISHER & PAYKEL HEALTHCARE REPRESENTATIVE THAT TWO RT265 INFANT BREATHING CIRCUIT KIT TEMPERATURE PROBES BECAME DISCONNECTED FROM THE PATIENT END. NO PATIENT CONSEQUENCE WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    358647 INFANT DUAL HEATED EVAQUA2 BREATHING CIRCUIT BZE BZE FISHER & PAYKEL HEALTHCARE LTD RT266 120926

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention