BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFANT DUAL-HEATED EVAQUA BREATHING CIRCUIT

    MDR report key: 4133700 · Received October 1, 2014

    Report

    Report Number
    9611451-2014-00790
    Event Type
    Malfunction
    Date Received
    October 1, 2014
    Report Date
    September 4, 2014
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LIMITED
    Product Code
    BZE
    PMA / PMN Number
    K034026
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FI
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE COMPLAINT RT236 INFANT BREATHING CIRCUITS WERE NOT RETURNED TO FISHER AND PAYKEL HEALTHCARE IN (B)(4) FOR EVALUATION. DESPITE REQUESTS FOR THE RETURN OF THE RT236 INFANT BREATHING CIRCUITS, THE DEVICES WILL NOT BE RETURNING FOR INVESTIGATION. THEREFORE, OUR INVESTIGATION IS BASED ON THE EVENT DESCRIPTION, INFORMATION PROVIDED BY THE HOSPITAL AND OUR KNOWLEDGE OF THE PRODUCT. THE HOSPITAL REPORTED THAT TWO RT236 INFANT BREATHING CIRCUITS HAD A CRACKED SWIVEL WYE. A LOT CHECK REVEALED ONE OTHER SIMILAR COMPLAINT FOR LOT DATE 131015. WITHOUT THE RETURN OF THE COMPLAINT DEVICES WE ARE UNABLE TO DETERMINE WHAT MAY HAVE CAUSED THE PROBLEM EXPERIENCED BY THE CUSTOMER. ALL RT236 BREATHING CIRCUITS ARE VISUALLY INSPECTED AND PRESSURE TESTED FOR LEAKS BEFORE RELEASING FOR DISTRIBUTION. ANY BREATHING CIRCUIT WHICH FAILS ANY OF THESE TESTS IS DISCARDED. THIS SUGGESTS THAT THE SWIVEL ASSEMBLY WAS DAMAGED AFTER THE BREATHING CIRCUITS WERE RELEASED FOR DISTRIBUTION. OUR USER INSTRUCTIONS THAT ACCOMPANY THE RT236 INFANT DUAL HEATED EVAQUA 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."

    Additional Manufacturer Narrative · 1

    (B)(4). THE COMPLAINT RT236 INFANT BREATHING CIRCUITS ARE CURRENTLY EN ROUTE TO FISHER & PAYKEL HEALTHCARE FOR EVALUATION. WE WILL PROVIDE A FOLLOW UP REPORT UPON COMPLETION OF OUR INVESTIGATION.

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED VIA A FISHER & PAYKEL HEALTHCARE FIELD REPRESENTATIVE THAT THE SWIVELS OF TWO RT236 INFANT BREATHING CIRCUITS WERE DAMAGED. THIS WAS OBSERVED PRIOR TO PATIENT USE.

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED VIA A FISHER & PAYKEL HEALTHCARE FIELD REPRESENTATIVE THAT THE SWIVELS OF TWO RT236 INFANT BREATHING CIRCUITS WERE DAMAGED. THIS WAS OBSERVED PRIOR TO PATIENT USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    610890 INFANT DUAL-HEATED EVAQUA BREATHING CIRCUIT BZE BZE FISHER & PAYKEL HEALTHCARE LIMITED RT236 131015

    Patients

    Seq Age Sex Outcome Treatment
    1