BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFANT DUAL-HEATED EVAQUA BREATHING CIRCUIT

    MDR report key: 1857336 · Received October 6, 2010

    Report

    Report Number
    9611451-2010-00598
    Event Type
    Malfunction
    Date Received
    October 6, 2010
    Report Date
    September 9, 2010
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LTD
    Product Code
    BZE
    PMA / PMN Number
    K034026
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). METHOD: FIVE COMPLAINT DEVICES WERE RECEIVED. FOUR WERE COMPLAINT BREATHING CIRCUITS AND ONE WAS A SWIVEL. THE LOT NUMBER FOR TWO COMPLAINT DEVICES WAS 100713. THE LOT NUMBER FOR THE OTHER TWO COMPLAINT DEVICES WAS 100816. NO LOT NUMBER WAS PROVIDED FOR THE FIFTH COMPLAINT SWIVEL. THE COMPLAINT DEVICES WERE PRESSURE TESTED AND SUBMERGED IN A WATER BATH TO TEST FOR LEAKS. RESULTS: THE PRESSURE TEST REVEALED EXCESSIVE LEAK FOR ALL FIVE DEVICES. THE WATER BATH TEST IDENTIFIED THAT THERE WAS A LEAK AROUND THE SWIVEL. A LOT CHECK REVEALED NO OTHER COMPLAINTS OF THIS NATURE FOR THE LOT NUMBERS PROVIDED. 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 CIRCUITS WOULD HAVE MET THE REQUIRED SPECIFICATION AT THE TIME OR PRODUCTION. (B)(4).

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED THAT FIVE RT236 INFANT DUAL-HEATED EVAQUA BREATHING CIRCUITS FAILED THE LEAK TEST ON A BIRD VENTILATOR. THIS WAS FOUND PRIOR TO PATIENT USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INFANT DUAL-HEATED EVAQUA BREATHING CIRCUIT BZE BZE FISHER & PAYKEL HEALTHCARE LTD RT236 100713, 100816

    Patients

    Seq Age Sex Outcome Treatment
    1 BIRD VENTILATOR