BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFANT DUAL-HEATED EVAQUA BREATHING CIRCUIT

    MDR report key: 1934806 · Received December 21, 2010

    Report

    Report Number
    9611451-2010-00766
    Event Type
    Malfunction
    Date Received
    December 21, 2010
    Date of Event
    November 22, 2010
    Report Date
    November 22, 2010
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LTD
    Product Code
    BZE
    PMA / PMN Number
    K034026
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). LOT NUMBER AND MANUFACTURER DEVICE DATE: 100629 - 06/29/2010, 100601 - 06/01/2010, 100804 - 08/04/2010, 100706 - 07/06/2010, 100602 - 06/02/2010. METHOD: EIGHT RETURNED COMPLAINT BREATHING CIRCUITS WERE VISUALLY INSPECTED, PRESSURE TESTED AND SUBMERGED IN A WATERBATH TO TEST FOR LEAKS. RESULTS: NO DAMAGES WERE OBSERVED ON THE BREATHING CIRCUITS. THE PRESSURE TEST REVEALED THE EIGHT COMPLAINT DEVICES TO BE OUT OF THE SPECIFICATION FOR THIS PRODUCT. THE WATERBATH TEST IDENTIFIED A LEAK AROUND THE SWIVEL OF THE EIGHT COMPLAINT DEVICES. A LOT CHECK REVEALED: NO OTHER SIMILAR COMPLAINTS OF THIS NATURE FOR LOT NUMBERS 100804, 100706 AND 100629. 1 OTHER SIMILAR COMPLAINT OF THIS NATURE FOR LOT NUMBER 100601. 2 OTHER SIMILAR COMPLAINTS OF THIS NATURE OF LOT NUMBER 100602. CONCLUSION: BREATHING CIRCUITS ARE COMPOSED OF MANY PARTS, THEREFORE LEAKS CAN OCCUR AT ANY OF THE CONNECTIONS. 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 IN PLACE, THE LEAK AT THE SWIVEL JOINT CAN BE 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).

    Additional Manufacturer Narrative · 1

    (B)(4). WE ARE CURRENTLY ENDEAVOURING TO OBTAIN MORE INFORMATION FROM THE CUSTOMER WITH REGARD TO THE COMPLAINT DEVICE. WE WILL PROVIDE A FOLLOW-UP REPORT UPON COMPLETION OF OUR INVESTIGATION.

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED THAT THE Y-PIECES THE RT236 INFANT DUAL-HEATED EVAQUA BREATHING CIRCUITS WERE FAILING THE VENTILATOR LEAK TEST. NO PATIENT CONSEQUENCE WAS REPORTED.

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED THAT THE Y-PIECES THE RT236 INFANT DUAL-HEATED EVAQUA BREATHING CIRCUITS WERE FAILING THE VENTILATOR LEAK TEST. NO PATIENT CONSEQUENCE WAS REPORTED.

    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 100601

    Patients

    Seq Age Sex Outcome Treatment
    1 SERVO-I VENTILATOR| SERVO-I VENTILATOR