BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADULT DUAL HEATED EVAQUA BREATHING CIRCUIT

    MDR report key: 2844160 · Received November 25, 2012

    Report

    Report Number
    9611451-2012-00852
    Event Type
    Malfunction
    Date Received
    November 25, 2012
    Date of Event
    November 5, 2012
    Report Date
    November 6, 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 COMPLAINT BREATHING CIRCUIT WAS RETURNED TO THE MANUFACTURER FOR EVALUATION. THE PINS ON BOTH THE EXPIRATORY AND INSPIRATORY LIMB OF THE COMPLAINT 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 PINS OF THE EXPIRATORY LIMB WAS BENT, CONFIRMING THE REPORTED FAULT. FULL INSERTION OF THE INSPIRATORY PINS AND HEATER WIRE ADAPTOR WAS SUCCESSFUL. A LOT CHECK COULD NOT BE PERFORMED AS NO LOT NUMBER WAS PROVIDED. 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 THE HEATER WIRE PINS DURING USE IF THE HEATER WIRE ADAPTOR IS INSERTED INTO THE HEATER WIRE PLUG ON AN ANGLE. FOR BENT PINS REPORTED TO US BY HEALTHCARE FACILITIES, IT IS IMPOSSIBLE FOR US TO DETERMINE WHETHER THE PINS WERE BENT DURING PRODUCTION OR BY THE END USER. (B)(4).

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED THAT THEY COULD NOT CONNECT THE HEATER WIRE TO THE EXPIRATORY LIMB OF AN RT340 ADULT DUAL HEATED EVAQUA BREATHING CIRCUIT. THIS WAS REPORTED PRIOR TO PATIENT USE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1