BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFANT DUAL-HEATED EVAQUA BREATHING CIRCUIT

    MDR report key: 2330785 · Received November 9, 2011

    Report

    Report Number
    9611451-2011-00691
    Event Type
    Malfunction
    Date Received
    November 9, 2011
    Date of Event
    October 10, 2011
    Report Date
    October 14, 2011
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LTD
    Product Code
    BZE
    PMA / PMN Number
    K034026
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). METHOD: THE EXTENSION LIMB OF THE COMPLAINT RT235 INFANT BREATHING CIRCUIT WAS RETURNED TO FISHER & PAYKEL HEALTHCARE NEW ZEALAND FOR VISUAL INSPECTION. RESULT: VISUAL INSPECTION REVEALED THAT THE PROBE CONNECTOR WAS CONNECTED TO THE COMPLAINT EXTENSION LIMB INSTEAD OF A 12M-12M CONNECTOR. TWO CORRUGATIONS NEAR THE PROBE CONNECTOR, WERE FOUND TO BE DAMAGED ON THE COMPLAINT EXTENSION LIMB. IT IS ALSO NOTED THAT THE PROBE CONNECTOR IS NOT PROPERLY INSERTED INTO THE TUBE. A LOT CHECK REVEALED NO OTHER COMPLAINT OF THIS TYPE FOR LOT 110406. CONCLUSION: WE ARE UNABLE TO DETERMINE IF THE REPORTED FAULT WAS DONE DURING ASSEMBLY OR ALTERED AFTER THE DEVICE HAS LEFT PRODUCTION. THERE ARE STANDARD OPERATING PROCEDURES THAT INSTRUCT THE OPERATORS TO SUFFICIENTLY INSERT THE CONNECTORS INTO THE TUBE. ALL BREATHING CIRCUITS ARE PRESSURE TESTED PRIOR TO LEAVING THE PRODUCTION LINE AND THE PRESENCE OF THE PROBE CONNECTOR IN THE UNHEATED LIMB WOULD HAVE BEEN IDENTIFIED BY THE PRODUCTION STAFF DURING THE PRESSURE TEST.

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED THAT THE PORT OF AN RT235 BREATHING CIRCUIT WAS INCORRECTLY ATTACHED TO THE EXTENSION TUBE OF THE EXPIRATORY CIRCUIT. 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 RT235 110406

    Patients

    Seq Age Sex Outcome Treatment
    1