BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADULT DUAL-HEATED BREATHING CIRCUIT

    MDR report key: 1845692 · Received September 27, 2010

    Report

    Report Number
    9611451-2010-00579
    Event Type
    Malfunction
    Date Received
    September 27, 2010
    Report Date
    September 2, 2010
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LTD
    Product Code
    BTT
    PMA / PMN Number
    K983112
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). METHOD: THE LOT NUMBER OF ONE COMPLAINT CIRCUIT WAS 100415. THE LOT NUMBER OF THE SECOND COMPLAINT CIRCUIT WAS 100505. THE TWO COMPLAINT BREATHING CIRCUITS WERE NOT AVAILABLE TO FISHER & PAYKEL HEALTHCARE FOR EVALUATION. AN INVESTIGATION WAS CARRIED OUT BASED ON INFORMATION PROVIDED BY THE COMPLAINANT (DISTRIBUTOR). RESULTS: THE DISTRIBUTOR REPORTED THAT THEY ATTEMPTED TO CONNECT THE BREATHING CIRCUITS TO SEVERAL DIFFERENT HEATER WIRE ADAPTORS, BUT WERE NOT ABLE TO ACHIEVE A PROPER CONNECTION. A LOT CHECK REVEALED NO OTHER COMPLAINTS OF THIS NATURE FOR EITHER LOT NUMBERS PROVIDED. CONCLUSION: ALL BREATHING CIRCUITS ARE TESTED FOR ELECTRICAL CONNECTION AND CONTINUITY DURING PRODUCTION. IT IS POSSIBLE FOR THE USER TO BEND 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 HEALTHCARE FACILITIES, IT IS IMPOSSIBLE FOR US TO DETERMINE WHETHER THE PINS WERE DAMAGED 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 HOSPITAL IN (B)(6) REPORTED VIA OUR DISTRIBUTOR THAT THE "WIRES AT THE END" OF TWO RT210 ADULT DUAL-HEATED BREATHING CIRCUIT KITS WERE BENT. THIS WAS OBSERVED PRIOR TO PATIENT USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ADULT DUAL-HEATED BREATHING CIRCUIT BTT BTT FISHER & PAYKEL HEALTHCARE LTD RT210 100415, 100505

    Patients

    Seq Age Sex Outcome Treatment
    1