BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADULT DUAL HEATED EVAQUA2 BREATHING CIRCUIT

    MDR report key: 5371725 · Received January 15, 2016

    Report

    Report Number
    9611451-2016-00016
    Event Type
    Malfunction
    Date Received
    January 15, 2016
    Date of Event
    November 16, 2015
    Report Date
    November 30, 2015
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LTD
    Product Code
    BZE
    PMA / PMN Number
    K122432
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) METHOD: THE INSPIRATORY LIMB FROM AN RT380 ADULT DUAL HEATED EVAQUA 2 BREATHING CIRCUIT WAS RETURNED TO FISHER & PAYKEL HEALTHCARE IN (B)(4). RESULTS: VISUAL INSPECTION OF THE RETURNED INSPIRATORY LIMB REVEALED THAT BOTH THE PROXIMAL AND DISTAL CONNECTORS WERE LOOSE. A LOT CHECK REVEALED NO OTHER COMPLAINTS OF THIS NATURE FOR LOT 150729. CONCLUSION: ALL RT380 ADULT DUAL HEATED EVAQUA 2 BREATHING CIRCUITS ARE VISUALLY INSPECTED AND LEAK TESTED PRIOR TO BEING RELEASED FOR DISTRIBUTION. BOTH THE PROXIMAL AND DISTAL CONNECTIONS ARE ALSO VISUALLY INSPECTED DURING THE ASSEMBLY PROCESS. ANY CIRCUITS THAT FAIL ARE REJECTED. THIS SUGGESTS THAT THE REPORTED PROBLEM OCCURRED AFTER THE CIRCUIT WAS RELEASED FOR DISTRIBUTION. THE HOSPITAL FURTHER REPORTED THAT THE REPORTED PROBLEM WAS ONLY NOTED AFTER SIX DAYS OF USE. THE USER INSTRUCTIONS THAT ACCOMPANY THE RT380 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 (FPH) REPRESENTATIVE THAT THE RT380 ADULT DUAL HEATED EVAQUA2 BREATHING CIRCUIT WAS CAUSING AN ALARM ON THE MR850 RESPIRATORY HUMIDIFIER. INSPECTION OF THE RETURNED DEVICE ON 16 DECEMBER 2015 REVEALED THAT THE CONNECTORS ON THE INSPIRATORY LIMB WERE LOOSE. THIS WAS FOUND AFTER SIX DAYS OF USE. NO PATIENT CONSEQUENCE WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    28420 ADULT DUAL HEATED EVAQUA2 BREATHING CIRCUIT BZE BZE FISHER & PAYKEL HEALTHCARE LTD RT380 1507290301

    Patients

    Seq Age Sex Outcome Treatment
    1