BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFANT BIAS FLOW BREATHING CIRCUIT

    MDR report key: 2385223 · Received December 21, 2011

    Report

    Report Number
    9611451-2011-00812
    Event Type
    Malfunction
    Date Received
    December 21, 2011
    Report Date
    November 29, 2011
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LTD
    Product Code
    BTT
    PMA / PMN Number
    SEE H10
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE RT225 BREATHING CIRCUIT IS NOT SOLD IN THE USA BUT IS SIMILAR TO A PRODUCT WHICH SOLD IN THE USA. THE 510(K) NUMBER OF THAT PRODUCT IS K20332. THE COMPLAINT BREATHING CIRCUIT IS CURRENTLY EN ROUTE TO THE MANUFACTURER. WE WILL PROVIDE A FOLLOW UP REPORT UPON COMPLETION OF OUR INVESTIGATION.

    Additional Manufacturer Narrative · 1

    (B)(4). THE RT225 BREATHING CIRCUIT IS NOT SOLD IN THE USA BUT IS SIMILAR TO A PRODUCT WHICH SOLD IN THE USA. THE 510(K) NUMBER OF THAT PRODUCT IS K20332. METHOD: THE RETURNED COMPLAINT BREATHING CIRCUIT WAS VISUALLY INSPECTED AND PERFORMANCE TESTED. RESULTS: THE RIGHT HEATER WIRE PIN OF THE INSPIRATORY LIMB OF THE CIRCUIT WAS BENT AND SPLIT AND FULL INSERTION OF THE HEATER WIRE ADAPTOR WAS NOT POSSIBLE. A LOT CHECK REVEALED NO OTHER COMPLAINTS FOR THE LOT NUMBER PROVIDED. 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 IF THE HEATER WIRE ADAPTOR 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. BENT PINS DO NOT PRECLUDE VENTILATION OF THE PATIENT, BUT PREVENT THE HEATING OF THE GAS DELIVERED. (B)(4).

    Description of Event or Problem · 1

    A DISTRIBUTOR IN (B)(6) REPORTED THAT THE HEATER WIRE PINS OF AN RT225 INFANT BIAS FLOW BREATHING CIRCUIT WERE SPLIT.

    Description of Event or Problem · 1

    A DISTRIBUTOR IN (B)(6) REPORTED THAT THE HEATER WIRE PINS OF AN RT225 INFANT BIAS FLOW BREATHING CIRCUIT WERE SPLIT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INFANT BIAS FLOW BREATHING CIRCUIT BTT BTT FISHER & PAYKEL HEALTHCARE LTD RT225 110215

    Patients

    Seq Age Sex Outcome Treatment
    1