BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADULT DUAL-HEATED WITH EVAQUA BREATHING CIRCUIT

    MDR report key: 2834509 · Received November 15, 2012

    Report

    Report Number
    9611451-2012-00827
    Event Type
    Malfunction
    Date Received
    November 15, 2012
    Date of Event
    October 12, 2012
    Report Date
    October 19, 2012
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LTD
    Product Code
    BZE
    PMA / PMN Number
    K983112
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). METHOD: THE PINS ON THE RETURNED COMPLAINT BREATHING DEVICE WERE TESTED TO SEE IF THEY COULD BE CONNECTED TO A HEATER WIRE ADAPTOR. RESULTS: FULL INSERTION OF THE HEATER WIRE ADAPTOR WAS NOT POSSIBLE AS THE HEATER WIRE PIN OF THE INSPIRATORY LIMB WAS SPLIT. FULL INSERTION OF THE EXPIRATORY PINS AND HEATER WIRE ADAPTOR WAS SUCCESSFUL. A LOT CHECK REVEALED NO OTHER COMPLAINTS OF THIS NATURE FOR THIS LOT NUMBER. CONCLUSION: ALL BREATHING CIRCUITS ARE TESTED FOR CONNECTIVITY AND ELECTRICAL CONTINUITY DURING PRODUCTION AND THOSE THAT FAIL ARE REJECTED. IT IS POSSIBLE FOR THE USER TO BEND OR SPLIT THE HEATER WIRE PINS DURING USE IF THE HEATER WIRE ADAPTOR IS INSERTED INTO THE HEATER WIRE PLUG ON AN ANGLE. FOR DAMAGED PINS REPORTED TO US BY HEALTHCARE FACILITIES, IT IS IMPOSSIBLE FOR US TO DETERMINE WHETHER THE PINS WERE BENT OR SPLIT DURING PRODUCTION OR BY THE END USER. (B)(4).

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED THAT THE HEATER WIRE OF THE INSPIRATORY LIMB OF AN RT340 ADULT DUAL-HEATED WITH EVAQUA BREATHING CIRCUIT COULD NOT BE CONNECTED. THIS WAS REPORTED PRIOR TO PATIENT USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ADULT DUAL-HEATED WITH EVAQUA BREATHING CIRCUIT BZE BZE FISHER & PAYKEL HEALTHCARE LTD RT340 120716

    Patients

    Seq Age Sex Outcome Treatment
    1