BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFANT DUAL-HEATED EVAQUA BREATHING CIRCUIT

    MDR report key: 1958963 · Received January 12, 2011

    Report

    Report Number
    9611451-2011-00031
    Event Type
    Malfunction
    Date Received
    January 12, 2011
    Report Date
    December 14, 2010
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LTD
    Product Code
    BZE
    PMA / PMN Number
    K034026
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE MANUFACTURER DATES: 04/20/2010, 07/13/2010, 01/13/2010. THE COMPLAINT DEVICE IS CURRENTLY EN ROUTE TO FISHER & PAYKEL HEALTHCARE FOR EVALUATION. WE WILL PROVIDE A FOLLOW UP REPORT UPON RECEIPT OF THE DEVICE AND COMPLETION OF OUR INVESTIGATION.

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE MANUFACTURER DATE - 04/20/2010; 07/13/2010; 01/13/2010. METHOD: EIGHT COMPLAINT DEVICES WERE RETURNED UNSEALED. THEY WERE VISUALLY INSPECTED, PRESSURE TESTED AND SUBMERGED IN A WATERBATH TO TEST FOR LEAKS: (B)(4) HAD LOT NUMBER 100113; (B)(4) HAD LOT NUMBER 100420; (B)(4) HAD LOT NUMBER 100713. RESULTS: THE VISUAL INSPECTION REVEALED NO DAMAGES TO THE EIGHT RETURNED COMPLAINT DEVICES. THE PRESSURE TEST FOUND THE PRESSURE DROP TO BE OUTSIDE THE SPECIFICATION FOR THIS PRODUCT, AND THE WATER BATH TEST IDENTIFIED THE LEAK TO BE AROUND THE SWIVEL OF THE BREATHING CIRCUIT FOR THE EIGHT RETURNED DEVICES. A LOT CHECK REVEALED: -NO OTHER COMPLAINTS OF THIS NATURE WITH LOT NUMBER 100113. (B)(4) OTHER COMPLAINTS OF THIS NATURE WITH LOT NUMBER 100420. (B)(4) OTHER COMPLAINTS OF THIS NATURE WITH LOT NUMBER 100713. 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).

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED THAT THE RT236 INFANT DUAL-HEATED EVAQUA BREATHING CIRCUITS DID NOT PASS THE SERVO-I VENTILATOR LEAK TEST. THIS WAS FOUND PRIOR TO PATIENT USE.

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED THAT NINE RT236 INFANT DUAL-HEATED EVAQUA BREATHING CIRCUITS DID NOT PASS THE SERVO-I VENTILATOR LEAK TEST. 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 100420, 100713, 100113

    Patients

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