BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADULT DUAL HEATED EVAQUA BREATHING CIRCUIT

    MDR report key: 3480026 · Received November 20, 2013

    Report

    Report Number
    9611451-2013-00923
    Event Type
    Malfunction
    Date Received
    November 20, 2013
    Date of Event
    October 24, 2013
    Report Date
    October 25, 2013
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LIMITED
    Product Code
    BZE
    PMA / PMN Number
    K983112
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE COMPLAINT RT340 ADULT DUAL HEATED EVAQUA BREATHING CIRCUIT IS EN ROUTE TO FISHER & PAYKEL HEALTHCARE IN (B)(4) FOR INVESTIGATION. WE WILL PROVIDE A FOLLOW-UP REPORT ONCE WE HAVE COMPLETED OUR INVESTIGATION.

    Additional Manufacturer Narrative · 1

    (B)(4). METHOD: ONLY THE INSPIRATORY LIMB OF THE COMPLAINT RT340 ADULT DUAL HEATED EVAQUA BREATHING CIRCUIT WAS RETURNED TO FISHER & PAYKEL HEALTHCARE 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 INSPIRATORY TUBE. THE ELECTRICAL RESISTANCE OF THE HEATERWIRE WAS HIGHER THAN SPECIFICATION. A LOT CHECK REVEALED NO OTHER COMPLAINTS OF THIS NATURE FOR LOT NUMBER 130617. 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 SUBJECT INSPIRATORY HEATERWIRE MALFUNCTIONED AFTER RELEASED FOR DISTRIBUTION. OUR MONITORING AND TRENDING OF HIGH ELECTRICAL RESISTANCE IN ADULT BREATHING CIRCUITS HAS A RATE OF OCCURRENCE OF (B)(4) DEVICES PER MILLION SOLD WORLDWIDE IN THE LAST YEAR TO THE END OF NOVEMBER 2013.

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED TO A DISTRIBUTOR THAT THE HEATERWIRE OF AN RT340 ADULT DUAL HEATED EVAQUA BREATHING CIRCUIT WAS NOT WARMING UP. THIS WAS OBSERVED BEFORE USE ON A PATIENT.

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED TO A DISTRIBUTOR THAT THE HEATERWIRE OF AN RT340 ADULT DUAL HEATED EVAQUA BREATHING CIRCUIT WAS NOT WARMING UP. THIS WAS OBSERVED BEFORE USE ON A PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    602678 ADULT DUAL HEATED EVAQUA BREATHING CIRCUIT BZE BZE FISHER & PAYKEL HEALTHCARE LIMITED RT340 130617

    Patients

    Seq Age Sex Outcome Treatment
    1