BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADULT DUAL-HEATED BREATHING CIRCUIT

    MDR report key: 2221113 · Received August 23, 2011

    Report

    Report Number
    9611451-2011-00515
    Event Type
    Malfunction
    Date Received
    August 23, 2011
    Date of Event
    July 22, 2011
    Report Date
    July 29, 2011
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LIMITED
    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 RT104 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 ELECTRICAL RESISTANCE OF THE HEATER WIRES IN THE INSPIRATORY AND EXPIRATORY TUBES OF THE RETURNED RT104 ADULT DUAL-HEATED BREATHING CIRCUIT WAS TESTED USING A MULTIMETER. A CONTINUITY TEST WAS USED TO LOCATE THE BREAK IN THE HEATER WIRES. RESULTS: AN ELECTRICAL RESISTANCE TESTING SHOWED THAT THE INSPIRATORY HEATER WIRE WAS OPEN CIRCUIT. CONTINUITY TESTING SHOWED THAT THE OPEN CIRCUIT IN THE INSPIRATORY HEATER WIRE WAS LOCATED IN THE CONNECTION BETWEEN THE HEATER WIRE AND THE HEATER WIRE PIN INSIDE THE OVERMODULATED PLUG. NO FAULT WAS FOUND WITH THE HEATER WIRE IN THE EXPIRATORY TUBE. A LOT CHECK REVEALED NO OTHER COMPLAINTS OF THIS NATURE FOR LOT NUMBER 100322 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. THE TIMING OF USE SHOWS THAT THE HEATER WIRE BECAME OPEN CIRCUIT POST PRODUCTION. OUR MONITORING AND TRENDING OF OPEN CIRCUIT HEATER WIRES IN ADULT BREATHING CIRCUITS HAS A RATE OF OCCURRENCE OF 15 DEVICES PER MILLION SOLD WORLDWIDE IN THE LAST YEAR TO THE END OF JULY 2011.

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED VIA A DISTRIBUTOR THAT AN RT104 ADULT DUAL-HEATED BREATHING CIRCUIT BECAME OPEN CIRCUIT AFTER THREE HOURS OF USE. NO PATIENT CONSEQUENCE WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ADULT DUAL-HEATED BREATHING CIRCUIT BTT BTT FISHER & PAYKEL HEALTHCARE LIMITED RT104 100322

    Patients

    Seq Age Sex Outcome Treatment
    1