BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFANT DUAL HEATED EVAQUA2 BREATHING CIRCUIT

    MDR report key: 2461386 · Received February 19, 2012

    Report

    Report Number
    9611451-2012-00085
    Event Type
    Malfunction
    Date Received
    February 19, 2012
    Report Date
    January 27, 2012
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LTD
    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 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 COMPLAINT RT265 INFANT BREATHING CIRCUIT WAS RETURNED TO FISHER & PAYKEL HEALTHCARE (B)(4) FOR EVALUATION. THE COMPLAINT DEVICE WAS PRESSURE TESTED AND SUBSEQUENTLY IMMERSED IN A WATERBATH TO TEST FOR LEAKS. RESULT: THE PRESSURE TEST RESULTS REVEALED THAT THE COMPLAINT DEVICE PERFORMED WITHIN THE REQUIRED SPECIFICATION. IMMERSION IN A WATERBATH SHOWED THAT THERE WAS A SMALL HOLE AT THE EXPIRATORY LIMB, APPROXIMATELY 0.6CM FROM THE HEATER WIRE SOCKET. A LOT CHECK REVEALED NO OTHER COMPLAINT OF THIS TYPE FOR LOT NUMBER 111102. CONCLUSION: WE WERE NOT ABLE TO REPLICATE THE REPORTED FAULT AS THE COMPLAINT RT265 BREATHING CIRCUIT WAS ABLE TO PASS THE PRESSURE TEST EVEN WITH A SMALL HOLE IN THE EXPIRATORY LIMB. ALL INFANT BREATHING CIRCUITS ARE PRESSURE AND FLOW TESTED BEFORE THEY ARE ALLOWED TO LEAVE THE PRODUCTION LINE. THIS IS AN AUTOMATED PROCESS AND THE CIRCUIT WOULD HAVE MET THE REQUIRED SPECIFICATION AT THE TIME OF PRODUCTION. OUR USER INSTRUCTIONS THAT ACCOMPANY THE RT265 STATE THE FOLLOWING: "CHECK ALL CONNECTIONS ARE TIGHT BEFORE USE." "PERFORM A PRESSURE AND LEAK TEST ON THE BREATHING SYSTEM AND CHECK FOR OCCLUSIONS 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 SALES REPRESENTATIVE THAT AN RT265 INFANT BREATHING CIRCUIT KIT WAS LEAKING AND UNABLE TO ACHIEVE AIRWAY PRESSURES. THIS WAS FOUND PRIOR TO PATIENT USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INFANT DUAL HEATED EVAQUA2 BREATHING CIRCUIT BZE BZE FISHER & PAYKEL HEALTHCARE LTD RT265 111102

    Patients

    Seq Age Sex Outcome Treatment
    1