BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADULT DUAL-HEATED BREATHING CIRCUIT

    MDR report key: 2192367 · Received August 4, 2011

    Report

    Report Number
    9611451-2011-00471
    Event Type
    Malfunction
    Date Received
    August 4, 2011
    Date of Event
    June 16, 2011
    Report Date
    July 5, 2011
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LTD
    Product Code
    BTT
    PMA / PMN Number
    REFER TO H10
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE RT204 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 (B)(4). METHOD: THE PINS ON THE EXPIRATORY AND INSPIRATORY LIMB OF THE COMPLAINT BREATHING CIRCUIT WERE TESTED TO SEE IF THEY COULD BE CONNECTED TO A HEATER WIRE ADAPTOR. RESULTS: THE HEATER WIRE PINS OF THE INSPIRATORY LIMB WERE WITHIN SPECIFICATION FOR THIS PRODUCT AS FULL INSERTION OF THE HEATER WIRE ADAPTOR WAS ACHIEVED. THE HEATER WIRE PINS OF THE EXPIRATORY LIMB WERE OUT OF SPECIFICATION AS A HEATER WIRE PIN WAS SPLIT, THEREFORE FULL INSERTION OF THE HEATER WIRE ADAPTOR WAS NOT POSSIBLE. A LOT CHECK REVEALED NO OTHER COMPLAINTS OF THIS NATURE FOR THIS LOT NUMBER. 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 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).

    Additional Manufacturer Narrative · 1

    (B)(4). THE COMPLAINT DEVICE HAS RECENTLY BEEN RETURNED TO FISHER & PAYKEL HEALTHCARE AND INVESTIGATION IS ANTICIPATED. WE WILL SEND A FOLLOW-UP REPORT UPON COMPLETION OF OUR INVESTIGATION.

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED VIA OUR DISTRIBUTOR THAT THE EXPIRATORY LIMB HEATER WIRE OF AN (B)(4) ADULT DUAL-HEATED BREATHING CIRCUIT COULD NOT BE CONNECTED. THIS WAS FOUND PRIOR TO USE.

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED VIA OUR DISTRIBUTOR THAT THE EXPIRATORY LIMB HEATER WIRE OF AN RT204 ADULT DUAL-HEATED BREATHING CIRCUIT COULD NOT BE CONNECTED. THIS WAS FOUND PRIOR TO USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ADULT DUAL-HEATED BREATHING CIRCUIT BTT BTT FISHER & PAYKEL HEALTHCARE LTD RT204 100129

    Patients

    Seq Age Sex Outcome Treatment
    1