BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADULT DUAL-HEATED BREATHING CIRCUIT

    MDR report key: 2705240 · Received August 19, 2012

    Report

    Report Number
    9611451-2012-00560
    Event Type
    Malfunction
    Date Received
    August 19, 2012
    Report Date
    July 26, 2012
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LIMITED
    Product Code
    BTT
    PMA / PMN Number
    SEE H10
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).LOT NUMBER MANUFACTURING DATE QUANTITY AFFECTED110310 03/10/2011 1110816 08/16/2011 1111219 12/19/2011 1THE COMPLAINT RT200 ADULT DUAL-HEATED BREATHING CIRCUITS ARE EN ROUTE TO FISHER & PAYKEL HEALTHCARE FOR INVESTIGATION. WE WILL PROVIDE A FOLLOW-UP REPORT ONCE WE HAVE COMPLETED OUR INVESTIGATION.

    Additional Manufacturer Narrative · 1

    (B)(4). LOT NUMBER: 110310, 110816, 111219, MANUFACTURING DATE: 03/10/2011, 08/16/2011, 12/19/2011, QUANTITY AFFECTED: (B)(4). THE RT200 ADULT DUAL-HEATED 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: THE COMPLAINT RT200 ADULT BREATHING CIRCUITS WERE RETURNED TO FISHER & PAYKEL HEALTHCARE IN (B)(4) FOR INSPECTION. A BENT PIN TEST WAS PERFORMED ON THE RETURNED BREATHING CIRCUITS TO SEE IF IT COULD BE CONNECTED TO A HEATER WIRE ADAPTOR. RESULTS: A HEATER WIRE ADAPTOR COULD NOT FULLY CONNECTED TO THE HEATER WIRE SOCKETS OF THE RETURNED BREATHING CIRCUITS. FURTHER INSPECTIONS REVEALED THAT THE BREATHING CIRCUITS WITH LOT NUMBERS 110310 AND 110816 HAD BENT INSPIRATORY HEATER WIRE PINS. THE EXPIRATORY HEATER WIRE PINS OF THE BREATHING CIRCUIT WITH LOT NUMBER 111219 WERE ALSO FOUND BENT. LOT CHECKS REVEALED NO OTHER COMPLAINTS OF THIS NATURE FOR THE ABOVE LOT NUMBERS. 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 HEALTHCARE 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 DISTRIBUTOR IN (B)(6) REPORTED THAT THREE RT200 ADULT DUAL-HEATED BREATHING CIRCUITS EACH HAD A BENT HEATER WIRE PIN. THIS WAS NOTICED WHEN THE BREATHING CIRCUITS WERE FIRST TAKEN OUT OF THE BAG.

    Description of Event or Problem · 1

    A DISTRIBUTOR IN (B)(6) REPORTED THAT THREE RT200 ADULT DUAL-HEATED BREATHING CIRCUITS EACH HAD A BENT HEATER WIRE PIN. THIS WAS NOTICED WHEN THE BREATHING CIRCUITS WERE FIRST TAKEN OUT OF THE PACKAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ADULT DUAL-HEATED BREATHING CIRCUIT BTT BTT FISHER & PAYKEL HEALTHCARE LIMITED RT200 SEE H10

    Patients

    Seq Age Sex Outcome Treatment
    1