BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADULT BREATHING CIRCUIT

    MDR report key: 2849879 · Received November 28, 2012

    Report

    Report Number
    9611451-2012-00865
    Event Type
    Malfunction
    Date Received
    November 28, 2012
    Date of Event
    November 1, 2012
    Report Date
    November 2, 2012
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LTD
    Product Code
    BTT
    PMA / PMN Number
    K983112
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). METHOD: THE INSPIRATORY LIMB OF THE COMPLAINT BREATHING CIRCUIT WAS RETURNED TO FISHER & PAYKEL HEALTHCARE (FPH) (B)(4) FOR INVESTIGATION. A HEATER WIRE RESISTANCE TEST OF THE INSPIRATORY HEATER WIRE WAS PERFORMED USING A CALIBRATED MULTIMETER. RESULTS: THE RESISTANCE TEST REVEALED THAT THE INSPIRATORY HEATER WIRE WAS OPEN CIRCUIT AS THE RESISTANCE WAS OUTSIDE OF SPECIFICATION. THE OPEN CIRCUIT OCCURRED AT THE CONNECTION BETWEEN THE HEATER WIRE AND ONE OF THE HEATER WIRE PINS INSIDE THE OVERMOULDED PLUG. A LOT CHECK REVEALED NO OTHER COMPLAINT OF THIS TYPE FOR LOT NUMBER 120620. CONCLUSION: THE INSPIRATORY HEATER WIRE WAS OPEN CIRCUIT DUE TO A BREAK IN CONNECTION BETWEEN THE HEATER WIRE AND THE HEATER WIRE PIN. THE CAUSE OF THE BREAK IN THE CONNECTION IS THE HEATER WIRE HAVING INSUFFICIENT CONNECTION WITH THE HEATER WIRE PIN DURING PRODUCTION, SUCH THAT IS UNABLE TO PROVIDE CONTINUITY FOR THE FULL PERIOD OF USE FOR THE PRODUCT. ALL RT202 BREATHING CIRCUITS ARE ELECTRICALLY TESTED DURING PRODUCTION AND THOSE THAT FAIL ARE REJECTED. THIS SUGGESTS THE HEATER WIRE BECAME OPEN CIRCUIT POST PRODUCTION. (B)(4).

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED VIA A FISHER & PAYKEL HEALTHCARE REPRESENTATIVE THAT AN RT202 ADULT BREATHING CIRCUIT CAUSED THE MR850 HUMIDIFIER TO ALARM 3 HOURS AFTER USE. THE CIRCUIT WAS REPLACED AND THE ISSUE WAS RESOLVED. NO PATIENT CONSEQUENCE WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ADULT BREATHING CIRCUIT BTT BTT FISHER & PAYKEL HEALTHCARE LTD RT202 120620

    Patients

    Seq Age Sex Outcome Treatment
    1 FPH MR850 HUMIDIFIER