BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFANT DUAL-HEATED EVAQUA BREATHING CIRCUIT

    MDR report key: 3962139 · Received July 28, 2014

    Report

    Report Number
    9611451-2014-00655
    Event Type
    Malfunction
    Date Received
    July 28, 2014
    Report Date
    July 9, 2014
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LTD
    Product Code
    BZE
    PMA / PMN Number
    K034026
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    RESPIRATORY THERAPIST

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE COMPLAINT RT236 INFANT DUAL HEATED EVAQUA BREATHING CIRCUIT WAS NOT RETURNED TO FPH IN (B)(4) FOR EVALUATION. THEREFORE THE INVESTIGATION IS BASED ON OUR KNOWLEDGE OF THE PRODUCT AND THE INFORMATION PROVIDED BY THE HOSPITAL. WITHOUT THE RETURN OF THE COMPLAINT DEVICE, WE WERE UNABLE TO DETERMINE THE CAUSE OF THE REPORTED EVENT. BASED ON OUR KNOWLEDGE OF THE PRODUCT, IT IS LIKELY THAT THE BREATHING CIRCUIT MAY HAVE BEEN SUBJECTED TO A PHYSICAL FORCE SUFFICIENT ENOUGH TO PARTIALLY SEPARATE THE SWIVEL ELBOW AND SWIVEL WYE. IT WAS REPORTED BY THE HOSPITAL THAT THE INCIDENT OCCURRED WHILE THE CIRCUIT WAS BEING HANDLED, AND EXCESSIVE FORCE APPLIED AT THIS TIME COULD HAVE CAUSED THE SWIVEL ELBOW AND WYE TO SEPARATE. 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 IT 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 ALARM."

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED VIA A FISHER & PAYKEL HEALTHCARE REPRESENTATIVE THAT THE SWIVEL ELBOW AND SWIVEL WYE OF AN RT236 NEONATAL BREATHING CIRCUIT SEPARATED DURING USE. NO PATIENT CONSEQUENCE WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    437947 INFANT DUAL-HEATED EVAQUA BREATHING CIRCUIT BZE BZE FISHER & PAYKEL HEALTHCARE LTD RT236

    Patients

    Seq Age Sex Outcome Treatment
    1