BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFANT DUAL-HEATED EVAQUA BREATHING CIRCUIT

    MDR report key: 1891391 · Received November 4, 2010

    Report

    Report Number
    9611451-2010-00664
    Event Type
    Malfunction
    Date Received
    November 4, 2010
    Report Date
    October 6, 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). COMPLAINT DEVICES WERE RECEIVED. TWO OF THESE WERE RETURNED IN SEALED PACKAGES. FOUR DEVICES HAD LOT NUMBER 100209, ONE DEVICE HAD LOT NUMBER 100601, THREE HAD LOT NUMBER 100602 AND THE LOT NUMBER FOR THE REMAINING THREE DEVICES WAS NOT AVAILABLE. THE DEVICES WERE VISUALLY INSPECTED, PRESSURE TESTED AND SUBMERGED IN A WATER BATH TO TEST FOR LEAKS. RESULTS: NO PHYSICAL DAMAGE WAS OBSERVED ON THE COMPLAINT DEVICES. THE PRESSURE TEST REVEALED THE PRESSURE DROP TO BE OUTSIDE SPECIFICATION FOR THE RETURNED COMPLAINT DEVICES. THE WATER BATH TEST IDENTIFIED LEAKS AROUND THE SWIVEL OF ALL RETURNED COMPLAINT DEVICES. A LOT CHECK REVEALED ONE OTHER COMPLAINT OF THIS NATURE FOR LOT NUMBER 100209, AND NO OTHER COMPLAINTS OF THIS NATURE FOR LOT NUMBERS 100601 OR 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. OUR MONITORING AND TRENDING OF SWIVEL LEAKS INVOLVING INFANT BREATHING CIRCUITS HAS A RATE OF OCCURRENCE OF (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). THE COMPLAINT DEVICE IS CURRENTLY EN ROUTE TO FISHER & PAYKEL HEALTHCARE IN (B)(4) FOR EVALUATION. 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 EIGHT RT236 INFANT DUAL-HEATED EVAQUA BREATHING CIRCUITS FAILED THE SERVO I VENTILATOR TEST. NO PATIENT CONSEQUENCE WAS REPORTED.

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED THAT EIGHT RT236 INFANT DUAL-HEATED EVAQUA BREATHING CIRCUITS FAILED THE SERVO I VENTILATOR 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, 100602, 100209

    Patients

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