BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADULT BREATHING CIRCUIT

    MDR report key: 3072070 · Received April 22, 2013

    Report

    Report Number
    9611451-2013-00318
    Event Type
    Malfunction
    Date Received
    April 22, 2013
    Date of Event
    March 25, 2013
    Report Date
    March 15, 2013
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LTD
    Product Code
    BTT
    PMA / PMN Number
    SEE H10
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE RT340 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 RT340 BREATHING CIRCUIT WAS RETURNED TO FISHER & PAYKEL HEALTHCARE (B)(4) FOR EVALUATION. THE ELECTRICAL RESISTANCE OF HEATER WIRE ON THE INSPIRATORY AND EXPIRATORY LIMBS WAS TESTED USING A MULTIMETER. RESULTS: THE HEATER WIRE RESISTANCE OF THE INSPIRATORY LIMB WAS FOUND TO BE OPEN CIRCUIT, WHILE THE HEATER WIRE RESISTANCE OF THE EXPIRATORY LIMB WAS FOUND TO BE WITHIN SPECIFICATION. A LOT CHECK REVEALED NO OTHER COMPLAINT OF THIS TYPE FOR LOT NUMBER 121130. CONCLUSION: ELECTRICAL OPEN CIRCUITS IN HEATER WIRES CAN BE ASSOCIATED WITH INSUFFICIENT CONNECTION WITH THE HEATER WIRE PIN DURING PRODUCTION, SUCH THAT IT IS UNABLE TO PROVIDE CONTINUITY FOR THE FULL PERIOD OF USE. RESISTANCE TESTS AND VISUAL INSPECTIONS ARE PERFORMED ON ALL BREATHING CIRCUITS DURING PRODUCTION AND THOSE THAT FAIL ARE REJECTED. THIS SUGGESTS THAT THE HEATER WIRE BECAME OPEN CIRCUIT POST PRODUCTION. (B)(4).

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED VIA A FPH PRODUCT SPECIALIST THAT A HEATER WIRE OPEN CIRCUIT OCCURRED ON AN RT340 ADULT BREATHING CIRCUIT AFTER 12 HOURS OF USE. NO PATIENT CONSEQUENCE WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    171543 ADULT BREATHING CIRCUIT BTT BTT FISHER & PAYKEL HEALTHCARE LTD RT340 121130

    Patients

    Seq Age Sex Outcome Treatment
    1