BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFANT DUAL-HEATED EVAQUA BREATHING CIRCUIT

    MDR report key: 1846338 · Received September 17, 2010

    Report

    Report Number
    9611451-2010-00559
    Event Type
    Malfunction
    Date Received
    September 17, 2010
    Date of Event
    August 19, 2010
    Report Date
    August 19, 2010
    Manufacturer
    FISHER & PAYKEL HEALTHCARE, LTD.
    Product Code
    BZE
    PMA / PMN Number
    K034026
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). METHOD: TWO COMPLAINT BREATHING CIRCUITS WERE RECEIVED. THE LOT NUMBER FOR ONE DEVICE WAS 100506. THE SECOND DEVICE LOT NUMBER WAS 100310. BOTH DEVICES WERE PRESSURE TESTED AND SUBMERGED IN A WATERBATH TO TEST FOR LEAKS. RESULTS: THE PRESSURE FOR BOTH DEVICES WAS OUT OF SPECIFICATION FOR THIS PRODUCT. THE WATERBATH TEST IDENTIFIED A LEAK AROUND THE SWIVEL IN BOTH BREATHING CIRCUITS. A LOT CHECK REVEALED NO OTHER COMPLAINTS OF THIS NATURE FOR LOT NUMBER 100506. THE LOT CHECK REVEALED 2 OTHER COMPLAINTS OF THIS NATURE FOR LOT NUMBER 100310. CONCLUSION: THE TWO PARTS THAT MAKE UP THE Y-SWIVEL ARE HELD TOGETHER BY A SNAP-FIT, WHICH HAS SOME INHERENT LEAKAGE THAT IS DETECTED AND COMPENSATED FOR BY THE VENTILATOR. IT IS POSSIBLE THAT IF NOT PROPERLY LOCKED INTO PLACE, THE LEAK BETWEEN THE SWIVEL JOINT WAS ENHANCED DURING TRANSPORT OR SETUP DESPITE HAVING PASSED THE LEAK TEST AT THE TIME OF PRODUCTION. ALL CIRCUITS ARE PRESSURE TESTED BEFORE THEY ARE ALLOWED TO LEAVE THE PRODUCTION LINE. THIS IS AN AUTOMATED PROCESS AND THE CIRCUIT WOULD HAVE MET THE REQUIRED SPECIFICATION AT THE TIME OF PRODUCTION. (B)(4).

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED THAT TEN RT235 BREATHING CIRCUITS HAVE FAILED THE VENTILATOR LEAK TEST. THIS WAS FOUND BEFORE PT USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INFANT DUAL-HEATED EVAQUA BREATHING CIRCUIT BZE FISHER & PAYKEL HEALTHCARE, LTD. RT235 100505

    Patients

    Seq Age Sex Outcome Treatment
    1