BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFANT DUAL HEATED EVAQUA2 BREATHING CIRCUIT

    MDR report key: 4191439 · Received October 21, 2014

    Report

    Report Number
    9611451-2014-00823
    Event Type
    Malfunction
    Date Received
    October 21, 2014
    Date of Event
    September 21, 2014
    Report Date
    September 22, 2014
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LTD
    Product Code
    BZE
    PMA / PMN Number
    K103767
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). METHOD: THE COMPLAINT RT265 INFANT EVAQUA2 BREATHING CIRCUIT WAS RETURNED TO FISHER & PAYKEL HEALTHCARE IN (B)(4) FOR EVALUATION. THE CIRCUIT WAS VISUALLY INSPECTED AND PRESSURE TESTED. RESULTS: THE PRESSURE TEST RESULT REVEALED THAT THE CIRCUIT WAS OUT OF SPECIFICATION. VISUAL INSPECTION REVEALED THAT THE SWIVEL WYE WAS CRACKED. A LOT CHECK REVEALED NO OTHER SIMILAR COMPLAINTS FOR LOT DATE 140609. CONCLUSION: WE WERE UNABLE TO DETERMINE THE CAUSE OF THE REPORTED FAULT. BASED ON THE SCUFF MARKS ON THE SWIVEL IT APPEARS LIKELY THAT THE CRACKING WAS CAUSED BY SOME FORM OF PHYSICAL IMPACT. ALL RT265 INFANT DUAL-HEATED EVAQUA2 BREATHING CIRCUITS ARE VISUALLY INSPECTED AND PRESSURE AND FLOW TESTED DURING PRODUCTION, AND THOSE THAT FAIL ARE REJECTED. THE HOSPITAL REPORTED THAT THE DAMAGE OCCURRED AFTER FOUR DAYS OF USE WHICH SUGGESTS THAT THE COMPLAINT SWIVEL BECAME DAMAGED AFTER THE PRODUCT WAS RELEASED FOR DISTRIBUTION. OUR USER INSTRUCTIONS THAT ACCOMPANY THE RT265 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 REPRESENTATIVE THAT THE PATIENT END CONNECTOR ON THE EXPIRATORY AND INSPIRATORY LIMBS OF AN RT265 INFANT DUAL-HEATED EVAQUA2 BREATHING CIRCUIT CRACKED AFTER FOUR DAYS OF USE. NO PATIENT CONSEQUENCE WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    668947 INFANT DUAL HEATED EVAQUA2 BREATHING CIRCUIT BZE BZE FISHER & PAYKEL HEALTHCARE LTD RT265 140609

    Patients

    Seq Age Sex Outcome Treatment
    1