BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADULT INSPIRATORY HEATED BREATHING CIRCUIT

    MDR report key: 3473593 · Received November 18, 2013

    Report

    Report Number
    9611451-2013-00918
    Event Type
    Malfunction
    Date Received
    November 18, 2013
    Date of Event
    September 11, 2013
    Report Date
    September 13, 2013
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LIMITED
    Product Code
    BTT
    PMA / PMN Number
    SEE H10
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE RT206 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. PS139127 WAS ORIGINALLY DEEMED NON-REPORTABLE DUE TO THE EVENT DESCRIPTION. UPON RECEIPT OF THE DEVICE AND COMPLETION OF OUR INVESTIGATION ON 15 NOVEMBER 2013 THE COMPLAINT WAS RE-ASSESSED AND FOUND TO BE REPORTABLE. METHOD: THE COMPLAINT RT206 ADULT BREATHING CIRCUIT WAS RETURNED FOR EVALUATION. THE ELECTRICAL RESISTANCE OF THE INSPIRATORY HEATER WIRE WAS TESTED USING A MULTIMETER. RESULTS: ELECTRICAL RESISTANCE TESTING SHOWED THAT THE INSPIRATORY LIMB HEATER WIRE WAS OPEN CIRCUIT. CONTINUITY TESTING SHOWED THAT THE OPEN CIRCUIT IN THE INSPIRATORY LIMB HEATER WIRE WAS LOCATED IN THE CONNECTION BETWEEN THE HEATER WIRE AND THE HEATER WIRE PIN INSIDE THE OVERMOULDED PLUG. A LOT CHECK REVEALED NO OTHER COMPLAINTS OF THIS NATURE FOR LOT NUMBER 130426. CONCLUSION: ELECTRICAL OPEN CIRCUITS IN HEATER WIRES ARE OFTEN ASSOCIATED WITH IMPROPER CRIMPING OF THE HEATER WIRE DURING PRODUCTION. ALL BREATHING CIRCUITS ARE ELECTRICALLY TESTED DURING PRODUCTION AND THOSE THAT FAIL ARE REJECTED. THIS SUGGESTS THAT THE OPEN CIRCUIT MUST HAVE DEVELOPED AFTER IT WAS RELEASED FOR DISTRIBUTION. THE HOSPITAL ALSO REPORTED THAT THE RT206 CIRCUIT STOPPED WORKING AFTER TWO DAYS OF USE. (B)(4).

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED VIA OUR DISTRIBUTOR THAT THE INSPIRATORY LIMB OF AN RT206 ADULT BREATHING CIRCUIT DID NOT WORK AFTER TWO DAYS OF USE. NO PATIENT CONSEQUENCE WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    596342 ADULT INSPIRATORY HEATED BREATHING CIRCUIT BTT BTT FISHER & PAYKEL HEALTHCARE LIMITED RT206 130426

    Patients

    Seq Age Sex Outcome Treatment
    1