BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFANT DUAL HEATED EVAQUA2 BREATHING CIRCUIT

    MDR report key: 3780743 · Received April 30, 2014

    Report

    Report Number
    9611451-2014-00385
    Event Type
    Malfunction
    Date Received
    April 30, 2014
    Report Date
    March 31, 2014
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LIMITED
    Product Code
    BZE
    PMA / PMN Number
    K103767
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). METHOD: THE COMPLAINT RT265 INFANT EVAQUA2 BREATHING CIRCUIT WAS RETURNED TO FISHER & PAYKEL HEALTHCARE AND WAS VISUALLY INSPECTED. RESULTS: VISUAL INSPECTION REVEALED THAT THE STRAIGHT CONNECTOR ON THE EXPIRATORY LIMB AT THE PATIENT END WAS CRACKED ACROSS THE ENTIRE LENGTH OF THE COLLAR. TWO MINOR CRACKS WERE OBSERVED AT THE OPPOSITE SIDE OF THE STRAIGHT CONNECTOR. A LOT CHECK COULD NOT BE PERFORMED AS NO LOT INFORMATION WAS PROVIDED. CONCLUSION: WE WERE UNABLE TO DETERMINE WHAT HAS CAUSED THE CONNECTOR TO CRACK. ALL RT265 INFANT EVAQUA2 BREATHING CIRCUITS ARE VISUALLY INSPECTED AND PRESSURE AND FLOW TESTED DURING PRODUCTION, AND THOSE THAT FAIL ARE REJECTED. THE CUSTOMER HAS CONFIRMED THAT THE SUBJECT BREATHING CIRCUIT WAS IN USE FOR 7 - 14 DAYS BEFORE THE DAMAGE WAS OBSERVED, WHICH INDICATES THAT THE 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." "THIS PRODUCT IS INTENDED TO BE USED FOR A MAXIMUM OF 7 DAYS."

    Description of Event or Problem · 1

    A HEALTHCARE FACILITY IN (B)(6) REPORTED TO A FISHER & PAYKEL HEALTHCARE FIELD REPRESENTATIVE THAT AN RT265 INFANT DUAL-HEATED EVAQUA2 BREATHING CIRCUIT CAME APART DURING USE. IT WAS REPORTED THAT THE PATIENT DESATURATED BRIEFLY BUT RECOVERED QUICKLY WITHOUT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    258676 INFANT DUAL HEATED EVAQUA2 BREATHING CIRCUIT BZE BZE FISHER & PAYKEL HEALTHCARE LIMITED RT265

    Patients

    Seq Age Sex Outcome Treatment
    1