BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADULT DUAL HEATED EVAQUA2 BREATHING CIRCUIT

    MDR report key: 4602217 · Received March 15, 2015

    Report

    Report Number
    9611451-2015-00132
    Event Type
    Malfunction
    Date Received
    March 15, 2015
    Report Date
    February 11, 2015
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LTD
    Product Code
    BZE
    PMA / PMN Number
    K122432
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). METHOD: THE COMPLAINT RT380 EVAQUA2 BREATHING CIRCUIT WAS RETURNED TO FISHER & PAYKEL HEALTHCARE (B)(4) AND WAS VISUALLY INSPECTED. RESULT: THE VISUAL INSPECTION FOUND THAT THERE WAS NO DAMAGE TO THE MDI PORT OR THE PORT CAP. THE MDI PORT AND PORT CAP WERE MEASURED AND WERE FOUND TO BE OUT OF SPECIFICATION. A LOT CHECK WAS PERFORMED AND NO SIMILAR COMPLAINTS WERE FOUND FOR LOT 140909. CONCLUSION: WE WERE UNABLE TO DETERMINE THE CAUSE OF THE REPORTED EVENT. ALL RT380 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. IF ANY FAULTS ARE DETECTED THE WHOLE BATCH IS PLACED ON HOLD FOR INVESTIGATION. THIS SUGGESTS THAT THE DAMAGE OCCURRED AFTER THE PRODUCT WAS RELEASED FOR DISTRIBUTION, DURING TRANSPORTATION OR STORAGE. THE USER INSTRUCTIONS THAT ACCOMPANY THE RT380 BREATHING CIRCUIT STATE THE FOLLOWING: -"CHECK ALL CONNECTIONS ARE TIGHT BEFORE USE." -"SET APPROPRIATE VENTILATOR ALARMS." -"PERFORM A PRESSURE AND LEAK TEST ON THE BREATHING SYSTEM AND CHECK FOR OCCLUSIONS BEFORE CONNECTING TO A PATIENT."

    Description of Event or Problem · 1

    A HOSPITAL IN THE (B)(6) REPORTED THAT THE CAP OF THE MDI PORT OF AN RT380 BREATHING CIRCUIT IS DISCONNECTING EASILY.NO PATIENT CONSEQUENCE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    176659 ADULT DUAL HEATED EVAQUA2 BREATHING CIRCUIT BZE BZE FISHER & PAYKEL HEALTHCARE LTD RT380 140909

    Patients

    Seq Age Sex Outcome Treatment
    1