BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFANT DUAL HEATED EVAQUA2 BREATHING CIRCUIT

    MDR report key: 4154173 · Received October 8, 2014

    Report

    Report Number
    9611451-2014-00801
    Event Type
    Malfunction
    Date Received
    October 8, 2014
    Date of Event
    September 4, 2014
    Report Date
    September 9, 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 RT268 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 COMPLAINT RT268 INFANT DUAL HEATED EVAQUA2 BREATHING CIRCUIT WAS RETURNED TO FISHER & PAYKEL HEALTHCARE IN (B)(4) WHERE IT WAS VISUALLY INSPECTED. RESULTS: VISUAL INSPECTION REVEALED THAT THE RESTRICTOR WAS CRACKED IN TWO PLACES. A LOT CHECK REVEALED NO OTHER COMPLAINTS OF THIS NATURE FOR LOT 140506. CONCLUSION: WE WERE UNABLE TO DETERMINE THE ROOT CAUSE OF THE DAMAGE OBSERVED ON THE RETURNED RESTRICTOR. OUR INVESTIGATION INCLUDED A CHECK OF OUR MANUFACTURING RECORDS WHICH DID NOT REVEAL ANY ISSUES. ALL INFANT BREATHING CIRCUITS ARE VISUALLY INSPECTED AND PRESSURE TESTED PRIOR TO BEING RELEASED FOR DISTRIBUTION. ANY CIRCUITS THAT FAIL THIS TEST ARE DISCARDED. THIS SUGGESTS THE RETURNED RESTRICTOR WAS ONLY DAMAGED AFTER BEING RELEASED FOR DISTRIBUTION. OUR USER INSTRUCTIONS THAT ACCOMPANY THE RT268 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 OCCLUSIONS BEFORE CONNECTING TO A PATIENT." - "SET APPROPRIATE VENTILATOR ALARMS".

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED TO A FISHER & PAYKEL HEALTHCARE (FPH) REPRESENTATIVE THAT A CRACK WAS FOUND ON THE RESTRICTOR OF AN RT268 INFANT DUAL HEATED EVAQUA2 BREATHING CIRCUIT. THIS WAS FOUND PRIOR TO PATIENT USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    631940 INFANT DUAL HEATED EVAQUA2 BREATHING CIRCUIT BZE BZE FISHER & PAYKEL HEALTHCARE LTD RT268 140506

    Patients

    Seq Age Sex Outcome Treatment
    1