BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFANT DUAL HEATED EVAQUA2 BREATHING CIRCUIT

    MDR report key: 5408937 · Received February 3, 2016

    Report

    Report Number
    9611451-2016-00033
    Event Type
    Malfunction
    Date Received
    February 3, 2016
    Date of Event
    January 8, 2016
    Report Date
    January 8, 2016
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LIMITED
    Product Code
    BZE
    PMA / PMN Number
    SEE H10
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    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 K103767. METHOD: THE COMPLAINT RT268 CIRCUIT WAS RECEIVED AND WAS VISUALLY INSPECTED AND MECHANICALLY TESTED. A PRESSURE TEST WAS ALSO PERFORMED TO CHECK FOR LEAK. RESULTS: THE ELBOW AND SWIVEL WERE RETURNED DISASSEMBLED. NO DAMAGE WAS OBSERVED TO EITHER COMPONENT. THE SWIVEL AND ELBOW WERE ASSEMBLED TOGETHER TO ALLOW THE BREATHING CIRCUIT TO BE PRESSURE TESTED. IT WAS ALSO NOTED THAT ONCE REASSEMBLED THE TWO SWIVEL COMPONENTS FORMED A TIGHT FIT. THE PRESSURE TEST REVEALED THAT THE BREATHING CIRCUIT WAS WITHIN SPECIFICATION AND NOT LEAKING. A LOT CHECK REVEALED NO OTHER COMPLAINTS FOR THE LOT NUMBER PROVIDED. CONCLUSION: WE ARE UNABLE TO DETERMINE WHAT MAY HAVE CAUSED THE PROBLEM REPORTED BY THE CUSTOMER. THE INFANT SWIVEL ELBOW AND SWIVEL WYE IS ASSEMBLED USING A MACHINE TO ENSURE A CONSISTENT TIGHTNESS OF CONNECTION. THE SWIVEL ASSEMBLY IS THEN 100% PRESSURE AND FLOW TESTED AS PART OF THE INFANT BREATHING CIRCUIT BEFORE LEAVING THE PRODUCTION LINE. ANY CIRCUITS THAT FAIL THESE TESTS ARE REJECTED. THE USER INSTRUCTIONS THAT ACCOMPANY THE RT268 ALSO 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.

    Additional Manufacturer Narrative · 1

    (B)(4). THE RT268 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 K103767. MANUFACTURER NARRATIVE: THE COMPLAINT BREATHING CIRCUIT IS EN ROUTE TO FISHER & PAYKEL HEALTHCARE IN (B)(4) FOR INVESTIGATION. WE WILL PROVIDE A FOLLOW-UP REPORT ONCE WE HAVE COMPLETED OUR INVESTIGATION.

    Description of Event or Problem · 1

    A HOSPITAL IN THE (B)(6) REPORTED TO A FISHER & PAYKEL HEALTHCARE (FPH) FIELD REPRESENTATIVE THAT WHILE A PATIENT WAS ON AN SLE5000 VENTILATOR, RECEIVING NITRIC THERAPY AND OSCILLATION, THE SWIVEL OF AN RT268 INFANT DUAL HEATED EVAQUA2 BREATHING CIRCUIT CAME APART. NO PATIENT HARM WAS REPORTED AS A RESULT OF THIS INCIDENT.

    Description of Event or Problem · 1

    A HOSPITAL IN THE UK REPORTED TO A FISHER & PAYKEL HEALTHCARE (FPH) FIELD REPRESENTATIVE THAT WHILE A PATIENT WAS ON AN SLE5000 VENTILATOR, RECEIVING NITRIC THERAPY AND OSCILLATION, THE SWIVEL OF AN RT268 INFANT EVAQUA2 BREATHING CIRCUIT CAME APART. NO PATIENT HARM WAS REPORTED AS A RESULT OF THIS INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    64885 INFANT DUAL HEATED EVAQUA2 BREATHING CIRCUIT BZE BZE FISHER & PAYKEL HEALTHCARE LIMITED RT268 1509070101

    Patients

    Seq Age Sex Outcome Treatment
    1