BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFANT DUAL HEATED EVAQUA2 BREATHING CIRCUIT

    MDR report key: 3083789 · Received April 29, 2013

    Report

    Report Number
    9611451-2013-00331
    Event Type
    Malfunction
    Date Received
    April 29, 2013
    Report Date
    April 5, 2013
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LIMITED
    Product Code
    BZE
    PMA / PMN Number
    SEE H10
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE RT265 INFANT DUAL HEATED EVAQUA2 BREATHING CIRCUIT IS NOT SOLD IN THE USA BUT IT IS SIMILAR TO A PRODUCT SOLD IN THE USA. THE 510(K) FOR THAT PRODUCT IS K034026. METHOD: THE RT265 BREATHING CIRCUIT KIT WAS RETURNED TO FPH IN (B)(4) IN AN UNSEALED CONDITION. IT WAS VISUALLY INSPECTED AND PRESSURE TESTED FOR LEAKS. RESULTS: THE BREATHING CIRCUIT KIT WAS INSPECTED EXTERNALLY AND NO ISSUES WERE NOTED. THE PRESSURE TEST RESULT WAS ALSO WITHIN SPECIFICATION. A LOT CHECK REVEALED NO OTHER COMPLAINTS OF THIS NATURE FOR LOT NUMBER 121102. CONCLUSION: NO FAULT WAS FOUND WITH THE RETURNED BREATHING CIRCUIT KIT. ALL BREATHING CIRCUITS ARE VISUALLY INSPECTED AND PRESSURE TESTED FOR LEAKS DURING PRODUCTION, AND THOSE THAT FAIL ARE REJECTED. THE USER INSTRUCTIONS SUPPLIED WITH THE RT265 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 ALARM."

    Additional Manufacturer Narrative · 1

    (B)(4). THE RT265 INFANT DUAL HEATED EVAQUA2 BREATHING CIRCUIT IS NOT SOLD IN THE USA BUT IT IS SIMILAR TO A PRODUCT SOLD IN THE USA. THE 510(K) FOR THAT PRODUCT IS K034026. THE COMPLAINT INFANT BREATHING CIRCUIT IS EN ROUTE TO FISHER & PAYKEL HEALTHCARE FOR INVESTIGATION. WE WILL PROVIDE A FOLLOW-UP REPORT ONCE WE HAVE COMPLETED OUR INVESTIGATION.

    Description of Event or Problem · 1

    A MEDICAL CENTRE IN (B)(6) REPORTED TO A FISHER & PAYKEL HEALTHCARE (FPH) FIELD REPRESENTATIVE THAT AN RT265 INFANT DUAL HEATED EVAQUA2 BREATHING CIRCUIT FAILED THE VENTILATOR LEAK TEST DURING SET UP.

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED TO A FISHER & PAYKEL HEALTHCARE (FPH) FIELD REPRESENTATIVE THAT AN RT265 INFANT DUAL HEATED EVAQUA2 BREATHING CIRCUIT FAILED THE VENTILATOR LEAK TEST DURING SET UP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    183294 INFANT DUAL HEATED EVAQUA2 BREATHING CIRCUIT BZE BZE FISHER & PAYKEL HEALTHCARE LIMITED RT265 121102

    Patients

    Seq Age Sex Outcome Treatment
    1