BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFANT DUAL HEATED EVAQUA2 BREATHING CIRCUIT

    MDR report key: 6393561 · Received March 9, 2017

    Report

    Report Number
    9611451-2017-00178
    Event Type
    Malfunction
    Date Received
    March 9, 2017
    Report Date
    February 8, 2017
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LTD
    Product Code
    BZE
    PMA / PMN Number
    SEE H10
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IS
    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. THE COMPLAINT RT268 INFANT DUAL-HEATED EVAQUA2 BREATHING CIRCUIT IS EXPECTED BUT HAS NOT YET BEEN RETURNED TO FISHER & PAYKEL HEALTHCARE TO DETERMINE IF IT CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. WE WILL SUBMIT A FOLLOW UP REPORT UPON COMPLETION OF OUR INVESTIGATION.

    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 CIRCUIT WAS RETURNED TO FISHER AND PAYKEL HEALTHCARE (B)(4) FOR INSPECTION. IT WAS VISUALLY INSPECTED AND PRESSURE TESTED. RESULT: VISUAL INSPECTION REVEALED THAT THERE WAS NO DAMAGE TO THE BREATHING CIRCUIT AT THE CONNECTION BETWEEN THE CIRCUIT AND THE SWIVEL WYE. THE PRESSURE TEST RESULT WAS WITHIN THE SPECIFICATION. CONCLUSION: WE WERE UNABLE TO DETERMINE WHAT MAY HAVE CAUSED THE EVENT REPORTED BY THE CUSTOMER AS THERE WERE NO FAULT FOUND WITH THE COMPLAINT RT268 CIRCUIT THAT WAS RETURNED FOR INVESTIGATION. ALL RT268 INFANT DUAL HEATED EVAQUA2 BREATHING CIRCUITS ARE VISUALLY INSPECTED AND PRESSURE AND FLOW TESTED DURING PRODUCTION, AND THOSE THAT FAIL ARE REJECTED. OUR USER INSTRUCTIONS THAT ACCOMPANY THE RT268 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 FIELD REPRESENTATIVE THAT THERE WERE LOOSE CONNECTIONS IN THE RT268 INFANT EVAQUA2 BREATHING CIRCUIT. IT WAS REPORTED THAT THE PROXIMAL LINE DIDN'T FIT PROPERLY AND THE SWIVEL WYE DISCONNECTED FROM THE REST OF THE CIRCUIT. NO PATIENT CONSEQUENCE WAS REPORTED.

    Description of Event or Problem · 1

    A DISTRIBUTOR IN (B)(4) REPORTED TO A FISHER AND PAYKEL HEALTHCARE FIELD REPRESENTATIVE THAT THERE WERE LOOSE CONNECTIONS IN THE RT268 INFANT EVAQUA2 BREATHING CIRCUIT. IT WAS REPORTED THAT THE PROXIMAL LINE DIDN'T FIT PROPERLY AND THE SWIVEL WYE DISCONNECTED FROM THE REST OF THE CIRCUIT. NO PATIENT CONSEQUENCE WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    175560 INFANT DUAL HEATED EVAQUA2 BREATHING CIRCUIT BZE BZE FISHER & PAYKEL HEALTHCARE LTD RT268 1509040101

    Patients

    Seq Age Sex Outcome Treatment
    1