BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADULT BREATHING CIRCUIT

    MDR report key: 2718492 · Received August 28, 2012

    Report

    Report Number
    9611451-2012-00581
    Event Type
    Malfunction
    Date Received
    August 28, 2012
    Date of Event
    July 27, 2012
    Report Date
    August 3, 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: ONE RT212 BREATHING CIRCUIT (INSPIRATORY & EXPIRATORY LIMBS) AND AN ADDITIONAL INSPIRATORY LIMB WERE RETURNED TO FISHER & PAYKEL HEALTHCARE (B)(4) FOR EVALUATION. THE ELECTRICAL RESISTANCE OF HEATER WIRE ON THE TWO INSPIRATORY LIMBS WAS TESTED USING A MULTIMETER. RESULTS: VISUAL INSPECTION REVEALED THAT NO DAMAGE WAS OBSERVED ON THE RETURNED DEVICES. ELECTRICAL RESISTANCE TESTING SHOWED THAT THE HEATER WIRE RESISTANCE OF ONE INSPIRATORY LIMB WAS OPEN CIRCUIT, WHILE THE ADDITIONAL INSPIRATORY LIMB HAD A HEATER WIRE RESISTANCE THAT WAS OUTSIDE OF SPECIFICATION. A LOT CHECK REVEALED NO OTHER COMPLAINT OF THIS TYPE FOR LOT NUMBER 111207. CONCLUSION: THE OPEN CIRCUIT AND RESISTANCE BEING OUTSIDE OF SPECIFICATION WAS DUE TO 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 RT212 BREATHING CIRCUITS ARE SUBJECTED TO A RESISTANCE TEST DURING PRODUCTION AND THOSE THAT FAIL ARE REJECTED. THIS SUGGESTS THE HEATER WIRE BECAME OPEN CIRCUIT OR OUT OF SPECIFICATION POST PRODUCTION. (B)(4).

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED VIA A FPH PRODUCT SPECIALIST THAT THE HUMIDIFIER ALARMED WHEN USED WITH TWO RT212 ADULT BREATHING CIRCUITS AND THE ALARM STOPPED WHEN THE CIRCUITS WERE CHANGED. THE HOSPITAL MENTIONED THE POSSIBILITY OF OPEN CIRCUIT. THIS WAS FOUND PRIOR TO PATIENT USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ADULT BREATHING CIRCUIT BTT BTT FISHER & PAYKEL HEALTHCARE LTD RT212 111207

    Patients

    Seq Age Sex Outcome Treatment
    1