BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADULT DUAL-HEATED WITH EVAQUA BREATHING CIRCUIT

    MDR report key: 2853835 · Received December 3, 2012

    Report

    Report Number
    9611451-2012-00881
    Event Type
    Malfunction
    Date Received
    December 3, 2012
    Date of Event
    November 5, 2012
    Report Date
    November 9, 2012
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LIMITED
    Product Code
    BZE
    PMA / PMN Number
    K983112
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). METHOD: THE EXPIRATORY AND INSPIRATORY LIMBS OF THE COMPLAINT RT340 ADULT DUAL-HEATED EVAQUA BREATHING CIRCUIT WAS RETURNED TO FPH IN (B)(4) FOR INSPECTION. THE HEATER WIRE PINS WERE TESTED TO SEE IF THEY COULD BE CONNECTED TO A HEATER WIRE ADAPTOR. RESULTS: FULL INSERTION OF THE HEATER WIRE ADAPTOR ON THE EXPIRATORY LIMB WAS NOT ACHIEVED AS ONE OF THE HEATER WIRE PINS WAS BENT. NO FAULT WAS FOUND WITH THE INSPIRATORY HEATER WIRE. A LOT CHECK REVEALED NO OTHER COMPLAINTS OF THIS NATURE FOR LOT NUMBER 120713. CONCLUSION: ALL BREATHING CIRCUITS ARE TESTED FOR CONNECTIVITY AND ELECTRICAL CONTINUITY DURING PRODUCTION AND THOSE THAT FAIL ARE REJECTED. THIS SUGGESTS THAT THE INSPIRATORY HEATER WIRE PINS WERE DAMAGED POST PRODUCTION. IT IS POSSIBLE FOR THE USER TO DAMAGE 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).

    Additional Manufacturer Narrative · 1

    (B)(4). THE COMPLAINT RT340 ADULT DUAL-HEATED WITH EVAQUA BREATHING CIRCUIT IS EN ROUTE TO FISHER & PAYKEL HEALTHCARE FOR INVESTIGATION. WE WILL PROVIDE A FOLLOW-UP REPORT ONCE WE HAVE COMPLETED OUR INVESTIGATION.

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED TO A FISHER & PAYKEL HEALTHCARE (FPH) FIELD REPRESENTATIVE THAT THE EXPIRATORY HEATER WIRE PINS OF AN RT340 ADULT DUAL-HEATED WITH EVAQUA BREATHING CIRCUIT WERE DAMAGED, PREVENTING CONNECTION OF THE BREATHING CIRCUIT TO THE HEATER WIRE ADAPTOR. THIS WAS OBSERVED PRIOR TO PATIENT USE.

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED TO A FISHER & PAYKEL HEALTHCARE (FPH) FIELD REPRESENTATIVE THAT THE EXPIRATORY HEATER WIRE PINS OF AN RT340 ADULT DUAL-HEATED WITH EVAQUA BREATHING CIRCUIT WERE DAMAGED, PREVENTING CONNECTION OF THE BREATHING CIRCUIT TO THE HEATER WIRE ADAPTOR. THIS WAS OBSERVED 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 LIMITED RT340 120713

    Patients

    Seq Age Sex Outcome Treatment
    1