BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFANT DUAL-HEATED WITH EVAQUA BREATHING CIRCUIT

    MDR report key: 2024536 · Received March 20, 2011

    Report

    Report Number
    9611451-2011-00176
    Event Type
    Malfunction
    Date Received
    March 20, 2011
    Date of Event
    February 22, 2011
    Report Date
    February 22, 2011
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LIMITED
    Product Code
    BZE
    PMA / PMN Number
    K034026
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EI
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). METHOD: TWO OF THE SIX AFFECTED RT236 INFANT BREATHING CIRCUITS WERE RETURNED TO FPH (B)(4) FOR INVESTIGATION. BOTH RETURNED BREATHING CIRCUITS WERE PRESSURE TESTED AND SUBMERGED IN A WATER BATH TO TEST FOR LEAKS. RESULTS: THE INFANT BREATHING CIRCUITS FAILED THE PRESSURE TEST. THE PRESSURE TEST RESULTS WERE OUTSIDE THE REQUIRED SPECIFICATIONS. UPON SUBMERSION IN A WATER BATH, THE LEAK WAS DETECTED AROUND THE SWIVEL Y-PIECE. A STRONG FORMATION OF BUBBLES WERE NOTICED AROUND THE SWIVEL. A LOT CHECK REVEALED FOUR OTHER COMPLAINTS OF THIS NATURE FOR LOT NUMBER 100712. CONCLUSION: THE LEAK WAS CAUSED BY AN INSUFFICIENT SEAL BETWEEN THE TWO PARTS OF THE SWIVEL Y-PIECE THAT ARE HELD TOGETHER BY A SNAP-FIT. ALL BREATHING CIRCUITS ARE PRESSURE TESTED DURING PRODUCTION AND THOSE THAT FAIL ARE REJECTED. THIS SUGGESTS THE LEAK DEVELOPED POST PRODUCTION. (B)(4).

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED TO A FISHER & PAYKEL HEALTHCARE (FPH) FIELD REPRESENTATIVE THAT SIX OUT OF A BOX OF 10 RT236 INFANT DUAL-HEATED WITH EVAQUA BREATHING CIRCUITS FAILED THE LEAK TEST DURING SET UP ON A VENTILATOR. NO PATIENT CONSEQUENCE WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INFANT DUAL-HEATED WITH EVAQUA BREATHING CIRCUIT BZE BZE FISHER & PAYKEL HEALTHCARE LIMITED RT236 100712

    Patients

    Seq Age Sex Outcome Treatment
    1