BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADULT INSPIRATORY-HEATED BREATHING CIRCUIT

    MDR report key: 1904828 · Received November 22, 2010

    Report

    Report Number
    9611451-2010-00700
    Event Type
    Malfunction
    Date Received
    November 22, 2010
    Date of Event
    October 20, 2010
    Report Date
    October 21, 2010
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LTD
    Product Code
    BTT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE RT105 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 WIRE IN THE INSPIRATORY TUBE OF THE RETURNED COMPLAINT BREATHING CIRCUIT WAS TESTED USING A MULTIMETER. A CONTINUITY TEST WAS USED TO LOCATE THE BREAK IN THE HEATER WIRE. RESULTS: THE INSPIRATORY LIMB HEATER WIRE WAS OUTSIDE OF SPECIFICATION. THE INSPIRATORY HEATER WIRE WAS OPEN CIRCUIT DUE TO A BREAK IN THE CONNECTION BETWEEN THE HEATER WIRE AND THE RIGHT HAND HEATER WIRE PIN INSIDE THE OVERMOULDED PLUG. A LOT CHECK REVEALED NO OTHER COMPLAINTS OF THIS NATURE FOR THIS LOT NUMBER. CONCLUSION: 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. THIS SUGGESTS THE HEATER WIRE BECAME OPEN CIRCUIT POST PRODUCTION, POSSIBLY AS A RESULT OF A WEAK CRIMP CONNECTION. (B)(4).

    Description of Event or Problem · 1

    A DISTRIBUTOR IN (B)(6) REPORTED THAT AN RT105 ADULT INSPIRATORY-HEATED BREATHING CIRCUIT DOES NOT HEAT, AS THE HEATER WIRE IS OPEN CIRCUIT. NO PATIENT CONSEQUENCE WAS REPORTED

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ADULT INSPIRATORY-HEATED BREATHING CIRCUIT BTT BTT FISHER & PAYKEL HEALTHCARE LTD RT105 091123

    Patients

    Seq Age Sex Outcome Treatment
    1