BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADULT DUAL HEATED BREATHING CIRCUIT

    MDR report key: 3436136 · Received October 29, 2013

    Report

    Report Number
    9611451-2013-00859
    Event Type
    Malfunction
    Date Received
    October 29, 2013
    Date of Event
    September 24, 2013
    Report Date
    September 30, 2013
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LTD
    Product Code
    BTT
    PMA / PMN Number
    SEE H10
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE RT200 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. THE COMPLAINT RT200 ADULT BREATHING CIRCUIT HAS TODAY BEEN RECEIVED AT FISHER & PAYKEL HEALTHCARE FOR EVALUATION. WE WILL PROVIDE A FOLLOW UP REPORT UPON COMPLETION OF OUR INVESTIGATION.

    Additional Manufacturer Narrative · 1

    (B)(4). THE RT200 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 CIRCUIT WAS RECEIVED AT FISHER & PAYKEL HEALTHCARE FOR EVALUATION AND WAS VISUALLY INSPECTED AND RESISTANCE TESTED USING A CALIBRATED MULTIMETER. RESULTS: VISUAL INSPECTION REVEALED NO DAMAGE TO THE COMPLAINT DEVICE. THE RESISTANCE TESTS SHOWED THAT BOTH THE INSPIRATORY AND EXPIRATORY LIMB HEATER WIRES WERE WITHIN SPECIFICATION. CONCLUSION: WE WERE UNABLE TO DETERMINE WHAT HAD CAUSED THE PROBLEM AS REPORTED BY THE CUSTOMER, AS THERE WAS NO FAULT FOUND WITH THE RETURNED COMPLAINT BREATHING CIRCUIT. ELECTRICAL OPEN CIRCUITS IN HEATER WIRES CAN BE ASSOCIATED WITH IMPROPER CRIMPING OF THE HEATER WIRE DURING PRODUCTION. ALL BREATHING CIRCUITS ARE ELECTRICALLY TESTED DURING PRODUCTION AND THOSE THAT FAIL ARE REJECTED.

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6), REPORTED VIA OUR DISTRIBUTOR THAT AN RT200 ADULT BREATHING CIRCUIT WOULD NOT HEAT.

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED VIA OUR DISTRIBUTOR THAT AN RT200 ADULT BREATHING CIRCUIT WOULD NOT HEAT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    554845 ADULT DUAL HEATED BREATHING CIRCUIT BTT BTT FISHER & PAYKEL HEALTHCARE LTD RT200 130529

    Patients

    Seq Age Sex Outcome Treatment
    1