BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFANT DUAL HEATED EVAQUA2 BREATHING CIRCUIT

    MDR report key: 3882434 · Received June 18, 2014

    Report

    Report Number
    9611451-2014-00534
    Event Type
    Malfunction
    Date Received
    June 18, 2014
    Date of Event
    May 18, 2014
    Report Date
    May 21, 2014
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LTD
    Product Code
    BZE
    PMA / PMN Number
    K103767
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). METHOD: THE COMPLAINT RT265 INFANT BREATHING CIRCUIT WAS NOT RETURNED TO FISHER & PAYKEL HEALTHCARE (FPH) (B)(4) FOR EVALUATION. THE INVESTIGATION IS THEREFORE BASED ON INFORMATION RECEIVED FROM THE CUSTOMER AND OUR KNOWLEDGE OF THE PRODUCT. RESULTS: THE HOSPITAL INFORMED FPH THAT THE RT265 CIRCUIT HAD PASSED THE VENTILATOR LEAK TEST WITH NO LEAK EXHIBITED, SO WE KNOW THAT THE BREATHING CIRCUIT WAS OPERATING PROPERLY AT THE OUTSET. THEY FURTHER STATED THAT THE LEAK OCCURRED AFTER 1.5 DAYS OF USE. CONCLUSION: THE BREATHING CIRCUIT HAD FUNCTIONED WITHOUT ISSUE FOR A DAY AND A HALF. WITHOUT THE COMPLAINT BREATHING CIRCUIT WE WERE UNABLE TO DETERMINE WHAT HAD CAUSED THE PROBLEM AS REPORTED BY THE CUSTOMER. ALL RT265 INFANT DUAL-HEATED EVAQUA2 BREATHING CIRCUITS ARE VISUALLY INSPECTED AND PRESSURE AND FLOW TESTED DURING PRODUCTION, AND THOSE THAT FAIL ARE REJECTED. THIS SUGGESTS THAT THE COMPLAINT CIRCUIT BECAME DAMAGED DURING USE. 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 THAT AN RT265 INFANT BREATHING CIRCUIT KIT THAT HAD BECOME DISCONNECTED FROM THE SWIVEL Y-PIECE. NO PATIENT CONSEQUENCE WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    357535 INFANT DUAL HEATED EVAQUA2 BREATHING CIRCUIT BZE BZE FISHER & PAYKEL HEALTHCARE LTD RT265

    Patients

    Seq Age Sex Outcome Treatment
    1