BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADULT DUAL HEATED EVAQUA BREATHING CIRCUIT

    MDR report key: 2796942 · Received October 18, 2012

    Report

    Report Number
    9611451-2012-00740
    Event Type
    Malfunction
    Date Received
    October 18, 2012
    Date of Event
    September 20, 2012
    Report Date
    September 20, 2012
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LTD
    Product Code
    BZE
    PMA / PMN Number
    SEE H10
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE RT340 ADULT DUAL-HEATED EVAQUA BREATHING CIRCUIT IS NOT SOLD IN THE USA BUT IT IS SIMILAR TO A PRODUCT SOLD IN THE USA. THE 510(K) FOR THAT PRODUCT IS K983112. METHOD: THE COMPLAINT RT340 BREATHING CIRCUIT WAS RETURNED TO FISHER & PAYKEL HEALTHCARE (FPH) (B)(4) FOR INSPECTION. THE INSPIRATORY AND EXPIRATORY LIMBS WERE PERFORMANCE TESTED. RESULTS: FULL INSERTION OF THE HEATER WIRE PINS OF THE EXPIRATORY LIMB WITH THE HEATER WIRE ADAPTOR WAS ACHIEVED, BUT FULL INSERTION OF THE HEATER WIRE PINS OF THE INSPIRATORY LIMB WITH THE HEATER WIRE ADAPTOR WAS NOT ACHIEVED. ONE OF THE HEATER WIRE PINS ON THE INSPIRATORY LIMB WAS FOUND TO BE BENT. A LOT CHECK REVEALED NO OTHER COMPLAINTS OF THIS TYPE FOR LOT 120424. 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 BENT OR SPLIT 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 VIA A FISHER & PAYKEL HEALTHCARE FIELD REPRESENTATIVE THAT THE HEATER WIRE PIN OF AN RT340 ADULT DUAL HEATED EVAQUA BREATHING CIRCUIT WAS DAMAGED. THIS WAS FOUND 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 120424

    Patients

    Seq Age Sex Outcome Treatment
    1