BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFANT DUAL-HEATED EVAQUA BREATHING CIRCUIT

    MDR report key: 1843159 · Received September 23, 2010

    Report

    Report Number
    9611451-2010-00577
    Event Type
    Malfunction
    Date Received
    September 23, 2010
    Date of Event
    August 19, 2010
    Report Date
    August 26, 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: THE COMPLAINT DEVICES HAVE NOT BEEN RECEIVED FOR EVALUATION, HOWEVER PHOTOGRAPHS AND A VIDEO WERE PROVIDED BY THE HOSPITAL. RESULTS: THE VIDEO CLEARLY SHOWED THAT ONE OF THE DEVICES WAS LEAKING AT THE SEAL BETWEEN THE SWIVEL ELBOW AND THE SWIVEL WYE. THE PHOTOGRAPHS PROVIDED SHOWED THE BIRD VENTILATOR DISPLAYING A FAILED LEAK TEST. A LOT CHECK REVEALED TWO OTHER COMPLAINTS FOR LOT NUMBER 100310 AND ONE OTHER SIMILAR COMPLAINT FOR LOT NUMBER 100506. 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 OF PRODUCTION. (B)(4).

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED THAT TWO RT235 BREATHING CIRCUITS HAD FAILED THE LEAK TEST ON A BIRD VIP GOLD VENTILATOR IN THE THEIR NEONATAL UNIT. THIS WAS FOUND BEFORE 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 RT235 100310, 100516

    Patients

    Seq Age Sex Outcome Treatment
    1 BIRD VIP GOLD VENTILATOR