BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADULT INSPIRATORY HEATED BREATHING CIRCUIT

    MDR report key: 3325929 · Received September 4, 2013

    Report

    Report Number
    9611451-2013-00661
    Event Type
    Malfunction
    Date Received
    September 4, 2013
    Date of Event
    July 29, 2013
    Report Date
    August 6, 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). METHOD: THE COMPLAINT RT205 CIRCUIT WAS RETURNED TO FISHER & PAYKEL HEALTHCARE (B)(4) AND THE HEATER WIRE WAS TESTED FOR CONTINUITY. RESULTS: THE HEATER WIRE ON THE RETURNED BREATHING CIRCUIT DID NOT PASS THE CONTINUITY TEST AS IT WAS FOUND TO HAVE HIGH RESISTANCE THAT IS OUTSIDE OF SPECIFICATION. VISUAL INSPECTION REVEALED NO DAMAGE TO THE RETURNED BREATHING CIRCUIT. A LOT CHECK REVEALED NO OTHER COMPLAINTS OF THIS NATURE FOR LOT 130124. CONCLUSION: THE HIGH RESISTANCE IN THE INSPIRATORY LIMB HEATER WIRE HAS BEEN FOUND TO BE CAUSED BY INTERMITTENT CONNECTION BETWEEN THE HEATER WIRE AND THE CONNECTOR PINS. ALL RT205 BREATHING CIRCUITS ARE RESISTANCE AND CONTINUITY TESTED DURING PRODUCTION, AND THOSE THAT FAIL ARE REJECTED. THIS SUGGESTS THAT THE COMPLAINT DEVICE WAS WITHIN SPECIFICATION PRIOR TO BEING RELEASED FOR DISTRIBUTION. (B)(4).

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED VIA A DISTRIBUTOR THAT AN RT205 ADULT INSPIRATORY HEATED BREATHING CIRCUIT CAUSED AN ALARM ON A MR850 HUMIDIFIER. THIS WAS FOUND PRIOR TO PATIENT USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    437718 ADULT INSPIRATORY HEATED BREATHING CIRCUIT BTT BTT FISHER & PAYKEL HEALTHCARE LTD RT205 130124

    Patients

    Seq Age Sex Outcome Treatment
    1 FISHER & PAYKEL HEALTHCARE MR850 RESP. HUMIDIFIER