BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADULT BREATHING CIRCUIT

    MDR report key: 2203208 · Received August 11, 2011

    Report

    Report Number
    9611451-2011-00476
    Event Type
    Malfunction
    Date Received
    August 11, 2011
    Date of Event
    July 11, 2011
    Report Date
    July 18, 2011
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LTD
    Product Code
    BTT
    PMA / PMN Number
    SEE H10
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE RT112 ADULT BREATHING CIRCUIT IS NOT SOLD IN THE USA BUT IT IS SIMILAR TO A PRODUCT WHICH IS SOLD IN THE USA. THE 510(K) FOR THAT PRODUCT IS K983112. METHOD: A BENT PIN TEST WAS PERFORMED ON THE INSPIRATORY HEATER WIRE OF THE RETURNED COMPLAINT RT112 BREATHING CIRCUIT TO SEE IF IT COULD BE CONNECTED TO A HEATER WIRE ADAPTOR. RESULTS: ONE OF THE INSPIRATORY HEATER WIRE PINS WAS BENT AND A HEATER WIRE ADAPTOR COULD NOT BE FULLY CONNECTED TO THE HEATER WIRE SOCKET IN THE INSPIRATORY TUBE. THIS PREVENTS FULL INSERTION OF THE HEATER WIRE ADAPTOR TO THE HEATER WIRE SOCKET. A LOT CHECK REVEALED NO OTHER COMPLAINTS OF THIS NATURE FOR LOT NUMBER 101217. 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 DAMAGE THE HEATER WIRE PINS DURING USE, FOR EXAMPLE, IF THE HEATER WIRE ADAPTOR IS INSERTED INTO THE HEATER WIRE PLUG ON AN ANGLE. FOR DAMAGED PINS REPORTED TO US BY HEALTH CARE FACILITIES, IT IS IMPOSSIBLE FOR US TO DETERMINE WHETHER THE PINS WERE DAMAGED DURING PRODUCTION OR BY THE END USER. (B)(4).

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED VIA A DISTRIBUTOR THAT A HEATER WIRE PIN OF A RT112 ADULT BREATHING CIRCUIT WAS DAMAGED. NO PATIENT CONSEQUENCE WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ADULT BREATHING CIRCUIT BTT BTT FISHER & PAYKEL HEALTHCARE LTD RT112 101217

    Patients

    Seq Age Sex Outcome Treatment
    1