BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFANT DUAL-HEATED EVAQUA BREATHING CIRCUIT

    MDR report key: 3997505 · Received August 10, 2014

    Report

    Report Number
    9611451-2014-00691
    Event Type
    Malfunction
    Date Received
    August 10, 2014
    Date of Event
    July 28, 2014
    Report Date
    July 29, 2014
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LIMITED
    Product Code
    BZE
    PMA / PMN Number
    K034026
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). METHOD: THE COMPLAINT RT236 INFANT BREATHING CIRCUIT WAS RETURNED TO FISHER & PAYKEL HEALTHCARE IN (B)(4) FOR EVALUATION. THE BREATHING CIRCUIT WAS VISUALLY INSPECTED AND PRESSURE TESTED. RESULTS: VISUAL INSPECTION REVEALED THAT THE RETURNED SWIVEL WYE WAS CRACKED. SCUFF MARKS WERE OBSERVED ON THE SWIVEL WYE. THE PRESSURE TEST IDENTIFIED THAT THE CIRCUIT WAS PERFORMING WITHIN SPECIFICATION. A LOT CHECK REVEALED NO OTHER COMPLAINTS OF THIS NATURE FOR LOT NUMBER 140324. CONCLUSION: BASED ON THE INSPECTION CONDUCTED, IT IS LIKELY THAT THE RETURNED BREATHING CIRCUIT MAY HAVE BEEN SUBJECTED TO A PHYSICAL FORCE SUFFICIENT ENOUGH TO DAMAGE THE SWIVEL WYE. 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 SUBJECT BREATHING CIRCUIT WAS 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."

    Description of Event or Problem · 1

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    474437 INFANT DUAL-HEATED EVAQUA BREATHING CIRCUIT BZE BZE FISHER & PAYKEL HEALTHCARE LIMITED RT236 140324

    Patients

    Seq Age Sex Outcome Treatment
    1