BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFANT DUAL HEATED EVAQUA2 BREATHING CIRCUIT

    MDR report key: 3686486 · Received March 18, 2014

    Report

    Report Number
    9611451-2014-00244
    Event Type
    Malfunction
    Date Received
    March 18, 2014
    Date of Event
    February 6, 2014
    Report Date
    February 20, 2014
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LTD
    Product Code
    BZE
    PMA / PMN Number
    SEE H10
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE RT267 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 K020332. METHOD: THE COMPLAINT BREATHING CIRCUIT WAS RETURNED TO FISHER & PAYKEL HEALTHCARE AND WAS VISUALLY INSPECTED. RESULTS: VISUAL INSPECTION REVEALED A CRACK IN THE RED SLE RESTRICTOR, ALONG THE FLOW LINE. A LOT CHECK REVEALED NO OTHER COMPLAINTS FOR LOT NUMBER 121005. CONCLUSION: THE CRACK ALONG THE FLOW LINE COULD HAVE MADE IT WEAKER THAN USUAL, AND IT THUS CRACKED WHEN THE USER TIGHTENED THE CONNECTORS DURING SET UP. THIS WAS LIKELY CAUSED BY A MOLDING DEFECT IN THE RESTRICTOR. ALL INFANT BREATHING CIRCUITS ARE VISUALLY INSPECTED AND PRESSURE AND FLOW TESTED DURING PRODUCTION, AND THOSE THAT FAIL ARE REJECTED. OUR USER INSTRUCTIONS THAT ACCOMPANY THE RT267 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 THAT THEY FOUND A CRACK ON THE RESTRICTOR DURING SET UP OF AN RT267 INFANT EVAQUA 2 BREATHING CIRCUIT. THIS WAS FOUND PRIOR TO PATIENT USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    160743 INFANT DUAL HEATED EVAQUA2 BREATHING CIRCUIT BZE BZE FISHER & PAYKEL HEALTHCARE LTD RT267 121005

    Patients

    Seq Age Sex Outcome Treatment
    1