BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFANT DUAL HEATED EVAQUA2 BREATHING CIRCUIT

    MDR report key: 3903454 · Received June 30, 2014

    Report

    Report Number
    9611451-2014-00579
    Event Type
    Malfunction
    Date Received
    June 30, 2014
    Date of Event
    May 17, 2014
    Report Date
    June 4, 2014
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LTD
    Product Code
    BZE
    PMA / PMN Number
    K103767
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). METHOD: THE COMPLAINT RT265 BREATHING CIRCUIT WAS RETURNED TO FISHER & PAYKEL HEALTHCARE (B)(4) AND WAS VISUALLY INSPECTED. RESULTS: VISUAL INSPECTION OF THE RETURNED BREATHING CIRCUIT REVEALED THAT THE COLLAR AT THE PATIENT END OF THE EXPIRATORY LIMB WAS CRACKED ALONG ITS LENGTH. A LOT CHECK WAS NOT PERFORMED AS A LOT NUMBER WAS NOT PROVIDED. CONCLUSION: WE WERE UNABLE TO DETERMINE WHAT HAS CAUSED THE COLLAR TO CRACK, HOWEVER IT MUST BE NOTED THAT THE SUBJECT BREATHING CIRCUIT HAD BEEN IN USE FOR TEN DAYS BEFORE THE CRACKING OCCURRED. 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 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. THIS PRODUCT IS INTENDED TO BE USED FOR A MAXIMUM OF 7 DAYS.

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED TO A FISHER & PAYKEL HEALTHCARE REPRESENTATIVE THAT THE PROXIMAL CONNECTOR ON THE EXPIRATORY LIMB OF AN RT265 INFANT DUAL-HEATED EVAQUA2 BREATHING CIRCUIT WAS CRACKED AFTER TEN DAYS OF USE WITH A HUMMING X VENTILATOR ON A PATIENT IN AN INCUBATOR. NO PATIENT CONSEQUENCE WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    379299 INFANT DUAL HEATED EVAQUA2 BREATHING CIRCUIT BZE BZE FISHER & PAYKEL HEALTHCARE LTD RT265

    Patients

    Seq Age Sex Outcome Treatment
    1 HUMMING X VENTILATOR