BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFANT CONTINUOUS FLOW BREATHING CIRCUIT

    MDR report key: 2686036 · Received August 8, 2012

    Report

    Report Number
    9611451-2012-00535
    Event Type
    Malfunction
    Date Received
    August 8, 2012
    Date of Event
    July 15, 2012
    Report Date
    July 16, 2012
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LTD
    Product Code
    BTT
    PMA / PMN Number
    K020332
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). METHOD: THE COMPLAINT RT329 CIRCUIT WAS RETURNED TO FISHER & PAYKEL HEALTHCARE (B)(4) AND TESTED BY CONNECTING A HEATER WIRE ADAPTOR TO THE HEATER WIRE PINS ON THE COMPLAINT DEVICE. RESULTS: FULL INSERTION OF THE INSPIRATORY HEATER WIRE ADAPTOR WAS NOT ACHIEVED. THE INSPIRATORY HEATER WIRE PINS WERE FOUND TO BE OUTSIDE OF SPECIFICATION. THE RIGHT INSPIRATORY HEATER WIRE PIN WAS FOUND TO BE SPLIT. A LOT CHECK REVEALED NO OTHER COMPLAINT FOR LOT NUMBER 120217. CONCLUSION: 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 NOT POSSIBLE FOR US TO DETERMINE WHETHER THE PINS WERE BENT DURING PRODUCTION OR BY THE END USER. ALL RT329 BREATHING CIRCUITS ARE VISUALLY INSPECTED DURING PRODUCTION AND TESTED BY INSERTING THE HEATER WIRE PINS INTO THE ADAPTORS. THOSE THAT FAIL THESE CHECKS ARE REJECTED. (B)(4).

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED VIA A FPH FIELD REPRESENTATIVE THAT THE HEATER WIRE PINS OF AN RT329 INFANT BREATHING CIRCUIT KIT WERE BENT. THIS WAS FOUND PRIOR TO PATIENT USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INFANT CONTINUOUS FLOW BREATHING CIRCUIT BTT BTT FISHER & PAYKEL HEALTHCARE LTD RT329 120217

    Patients

    Seq Age Sex Outcome Treatment
    1