BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADULT DUAL HEATED EVAQUA BREATHING CIRCUIT

    MDR report key: 3516067 · Received December 11, 2013

    Report

    Report Number
    9611451-2013-01002
    Event Type
    Malfunction
    Date Received
    December 11, 2013
    Date of Event
    November 14, 2013
    Report Date
    November 21, 2013
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LIMITED
    Product Code
    BZE
    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: ONE OF THE THREE COMPLAINT RT340 ADULT DUAL HEATED EVAQUA BREATHING CIRCUITS WAS RETURNED TO FPH IN (B)(4) FOR INSPECTION. IT WAS VISUALLY INSPECTED AND ELECTRICAL RESISTANCE TESTED USING A CALIBRATED MULTIMETER. RESULTS: NO PHYSICAL DAMAGE WAS OBSERVED TO THE RETURNED BREATHING CIRCUIT. THE ELECTRICAL RESISTANCE OF THE INSPIRATORY HEATERWIRE WAS HIGHER THAN SPECIFICATION. NO FAULT WAS FOUND TO THE EXPIRATORY HEATERWIRE. A LOT CHECK REVEALED NO OTHER COMPLAINTS OF THIS NATURE FOR LOT NUMBER 130808. CONCLUSION: HIGH ELECTRICAL RESISTANCE IN HEATERWIRES CAN BE ASSOCIATED WITH INSUFFICIENT CONNECTION OF THE HEATERWIRE AND THE HEATERWIRE PINS DURING PRODUCTION, SUCH THAT IT IS UNABLE TO PROVIDE CONTINUITY DURING THE PERIOD OF USE. ALL RT340 ADULT BREATHING CIRCUITS ARE RESISTANCE AND CONTINUITY TESTED DURING PRODUCTION, AND THOSE THAT FAIL ARE REJECTED. THIS SUGGESTS THAT THE INSPIRATORY HEATERWIRE OF THE COMPLAINT RT340 BREATHING CIRCUIT MALFUNCTIONED AFTER RELEASED FOR DISTRIBUTION. (B)(4).

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED TO A FISHER & PAYKEL HEALTHCARE (FPH) FIELD REPRESENTATIVE THAT A "HEATERWIRE DISCONNECT" ALARM SOUNDED ON THE MR850 RESPIRATORY HUMIDIFIER WHEN AN RT340 ADULT DUAL HEATED EVAQUA BREATHING CIRCUIT WAS CONNECTED. THIS WAS OBSERVED ON THREE RT340 UNITS WITH THE SAME LOT NUMBER, BEFORE THEY WERE USED ON A PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    649304 ADULT DUAL HEATED EVAQUA BREATHING CIRCUIT BZE BZE FISHER & PAYKEL HEALTHCARE LIMITED RT340 130808

    Patients

    Seq Age Sex Outcome Treatment
    1 MR850 RESPIRATORY HUMIDIFIER