BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFANT BREATHING CIRCUIT

    MDR report key: 2506495 · Received March 27, 2012

    Report

    Report Number
    9611451-2012-00180
    Event Type
    Malfunction
    Date Received
    March 27, 2012
    Date of Event
    March 7, 2012
    Report Date
    March 8, 2012
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LTD
    Product Code
    BTT
    PMA / PMN Number
    REFER TO H10
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE RT228 INFANT BREATHING CIRCUIT IS NOT SOLD IN THE USA BUT IS SIMILAR TO A PRODUCT THAT IS SOLD IN THE USA. THE 510(K) FOR THE SIMILAR PRODUCT IS K020332. METHOD: THE COMPLAINT RT228 INFANT BREATHING CIRCUIT WAS RETURNED TO FISHER & PAYKEL HEALTHCARE (B)(4) FOR INSPECTION. A VISUAL INSPECTION AND A BENT PIN TEST WERE PERFORMED. RESULTS: FULL INSERTION OF THE INSPIRATORY HEATER WIRE ADAPTER WAS NOT ACHIEVED. ONE OF THE INSPIRATORY HEATER WIRE PINS WAS FOUND TO BE BENT INWARDS. A LOT CHECK REVEALED NO OTHER COMPLAINT FOR LOT NUMBER 110914. CONCLUSION: ALL BREATHING CIRCUITS ARE TESTED FOR CONNECTIVITY AND ELECTRICAL CONTINUITY DURING PRODUCTION AND THOSE THAT FAIL ARE REJECTED. IT IS POSSIBLE FOR THE USER TO BEND THE HEATER WIRE PINS DURING USE IF THE HEATER WIRE ADAPTER IS INSERTED INTO THE HEATER WIRE PLUG ON AN ANGLE. FOR BENT PINS REPORTED TO US BY HEALTHCARE FACILITIES, IT IS IMPOSSIBLE FOR US TO DETERMINE WHETHER THE PINS WERE BENT DURING PRODUCTION OR BY THE END USER. DAMAGED PINS DO NOT PRECLUDE VENTILATION OF THE PATIENT, BUT PREVENT THE HEATING OF THE GAS DELIVERED. OUR TRENDING FOR INFANT BREATHING CIRCUITS WITH BENT, BROKEN OR DAMAGED HEATER WIRE PINS HAS A RATE WORLDWIDE OF (B)(4) DEVICES PER MILLION SOLD FOR THE PAST YEAR TO THE END OF FEBRUARY 2012.

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED THAT THE HEATER WIRE COULD NOT BE CONNECTED TO AN RT228 INFANT BREATHING CIRCUIT AS THE HEATER WIRE PIN WAS FOUND TO BE BENT. THIS WAS FOUND PRIOR TO PATIENT USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INFANT BREATHING CIRCUIT BTT BTT FISHER & PAYKEL HEALTHCARE LTD RT228 110914

    Patients

    Seq Age Sex Outcome Treatment
    1