BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADULT HEATED INSPIRATORY BREATHING CIRCUIT

    MDR report key: 2843194 · Received November 21, 2012

    Report

    Report Number
    9611451-2012-00833
    Event Type
    Malfunction
    Date Received
    November 21, 2012
    Date of Event
    October 22, 2012
    Report Date
    October 23, 2012
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LTD
    Product Code
    BTT
    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 INSPIRATORY LIMB OF THE COMPLAINT RT202 ADULT HEATED INSPIRATORY BREATHING CIRCUIT WAS RETURNED TO FISHER & PAYKEL HEALTHCARE IN (B)(4) FOR EVALUATION. THE INSPIRATORY HEATER WIRE PINS WERE TESTED TO SEE IF THEY COULD BE CONNECTED TO A HEATER WIRE ADAPTOR. RESULTS: FULL INSERTION OF THE INSPIRATORY HEATER WIRE PINS WITH THE HEATER WIRE ADAPTOR WAS NOT ACHIEVED. THE HEATER WIRE PINS ARE OUT OF SPECIFICATION. A LOT CHECK REVEALED NO OTHER COMPLAINTS OF THIS NATURE FOR LOT NUMBER 120605. 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 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 NOT POSSIBLE 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 TO A FISHER & PAYKEL HEALTHCARE REPRESENTATIVE THAT THEY COULD NOT CONNECT THE HEATER WIRE ADAPTOR TO THE INSPIRATORY LIMB OF AN RT202 ADULT HEATED INSPIRATORY BREATHING CIRCUIT. THIS WAS FOUND PRIOR TO PATIENT USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ADULT HEATED INSPIRATORY BREATHING CIRCUIT BTT BTT FISHER & PAYKEL HEALTHCARE LTD RT202 120605

    Patients

    Seq Age Sex Outcome Treatment
    1