BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFANT BIAS FLOW BREATHING CIRCUIT

    MDR report key: 1916759 · Received December 7, 2010

    Report

    Report Number
    9611451-2010-00732
    Event Type
    Malfunction
    Date Received
    December 7, 2010
    Date of Event
    October 25, 2010
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LIMITED
    Product Code
    BTT
    PMA / PMN Number
    SEE H10
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE RT125 BREATHING CIRCUIT IS NOT SOLD IN THE USA BUT IS SIMILAR TO A PRODUCT WHICH SOLD IN THE USA. THE 510(K) NUMBER OF THE SIMILAR PRODUCT IS K20332. METHOD: THE INSPIRATORY LIMB OF THE COMPLAINT BREATHING CIRCUIT WAS RETURNED FOR INVESTIGATION. THE STRAIGHTNESS OF THE HEATER WIRE PINS WAS TESTED BY CONNECTING THE CIRCUIT LIMB TO A HEATER WIRE ADAPTOR. RESULTS: A HEATER WIRE PIN ON THE INSPIRATORY LIMB OF THE BREATHING CIRCUIT WAS BENT, PREVENTING FULL INSERTION OF A HEATER WIRE ADAPTOR AND CONFIRMING THE REPORTED FAULT. A LOT CHECK REVEALED NO OTHER COMPLAINTS OF THIS NATURE FOR LOT NUMBER 090612. 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 ADAPTOR IS INSERTED INTO THE HEATER WIRE PLUG ON AN ANGLE. FOR BENT PINS REPORTED TO US BY HEALTH CARE 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. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). THE RT125 BREATHING CIRCUIT IS NOT SOLD IN THE USA BUT IS SIMILAR TO A PRODUCT WHICH IS SOLD IN THE USA. THE 510(K) NUMBER OF THE SIMILAR PRODUCT IS K20332. THE COMPLAINT DEVICE IS CURRENTLY EN ROUTE FOR EVALUATION. WE WILL PROVIDE A FOLLOW-UP REPORT UPON RECEIPT OF THE DEVICE AND COMPLETION OF OUR INVESTIGATION.

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED VIA A DISTRIBUTOR THAT THE HEATER WIRE PINS ON AN RT125 BREATHING CIRCUIT ARE BENT. THE BENT PINS WERE OBSERVED PRIOR TO PATIENT USE.

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED VIA A DISTRIBUTOR THAT THE HEATER WIRE PINS ON AN RT125 BREATHING CIRCUIT ARE BENT. THE BENT PINS WERE OBSERVED PRIOR TO PATIENT USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INFANT BIAS FLOW BREATHING CIRCUIT BTT BTT FISHER & PAYKEL HEALTHCARE LIMITED RT125 090612

    Patients

    Seq Age Sex Outcome Treatment
    1