BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFANT BIAS FLOW BREATHING CIRCUIT

    MDR report key: 2705254 · Received August 19, 2012

    Report

    Report Number
    9611451-2012-00561
    Event Type
    Malfunction
    Date Received
    August 19, 2012
    Report Date
    July 26, 2012
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LIMITED
    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 INFANT BIAS FLOW 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 COMPLAINT RT225 INFANT BREATHING CIRCUITS WERE RETURNED TO FISHER & PAYKEL HEALTHCARE IN (B)(4) FOR INSPECTION. A BENT PIN TEST WAS PERFORMED ON THE INSPIRATORY LIMBS OF THE RETURNED BREATHING CIRCUITS TO SEE IF IT COULD BE CONNECTED TO A HEATER WIRE ADAPTOR. RESULTS: A HEATER WIRE ADAPTOR COULD NOT FULLY CONNECTED TO THE HEATER WIRE SOCKET OF THE INSPIRATORY LIMBS. FURTHER INSPECTION REVEALED THAT THE INSPIRATORY HEATER WIRE PINS WERE BENT, PREVENTING THE ADAPTOR FROM CONNECTING TO THE HEATER WIRE SOCKET. A LOT CHECK REVEALED TWO OTHER COMPLAINTS OF THIS NATURE FOR LOT NUMBER 110215. 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 DAMAGE THE HEATER WIRE PINS DURING USE, FOR EXAMPLE, IF THE HEATER WIRE ADAPTOR IS INSERTED INTO THE HEATER WIRE PLUG ON AN ANGLE. FOR DAMAGED PINS REPORTED TO US BY HEALTHCARE FACILITIES, IT IS IMPOSSIBLE FOR US TO DETERMINE WHETHER THE PINS WERE DAMAGED DURING PRODUCTION OR BY THE END USER. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). THE RT225 INFANT BIAS FLOW 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 EN ROUTE TO FISHER & PAYKEL HEALTHCARE FOR INVESTIGATION. WE WILL PROVIDE A FOLLOW-UP REPORT ONCE WE HAVE COMPLETED OUR INVESTIGATION.

    Description of Event or Problem · 1

    A DISTRIBUTOR IN (B)(6) REPORTED THAT TWO RT225 INFANT BIAS FLOW BREATHING CIRCUIT EACH HAD A BENT HEATER WIRE PIN. THIS WAS NOTICED WHEN THE BREATHING CIRCUITS WERE FIRST TAKEN OUT OF THE PACKAGE.

    Description of Event or Problem · 1

    A DISTRIBUTOR IN (B)(6) REPORTED THAT TWO RT225 INFANT BIAS FLOW BREATHING CIRCUIT EACH HAD A BENT HEATER WIRE PIN. THIS WAS NOTICED WHEN THE BREATHING CIRCUITS WERE FIRST TAKEN OUT OF THE PACKAGE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1