BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADULT DUAL HEATED BREATHING CIRCUIT

    MDR report key: 1713881 · Received May 27, 2010

    Report

    Report Number
    9611451-2010-00294
    Event Type
    Malfunction
    Date Received
    May 27, 2010
    Date of Event
    April 20, 2010
    Report Date
    April 23, 2010
    Manufacturer
    FISHER & PAYKEL HEALTHCARE, LTD.
    Product Code
    BTT
    PMA / PMN Number
    K983112
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE RT200 IS NOT SOLD IN THE USA BUT IT IS SIMILAR TO A PRODUCT WHICH IS SOLD IN THE USA. THE 510(K) FOR THAT PRODUCT IS K983112. METHOD: THE RETURNED BREATHING CIRCUIT WAS TESTED FOR BENT PINS. RESULTS: THE INSPIRATORY LIMB HEATER WIRE PIN ON THE BREATHING CIRCUIT WAS BENT, PREVENTING FULL INSERTION OF A HEATER WIRE ADAPTOR. A LOT CHECK REVEALED NO OTHER COMPLAINTS OF THIS NATURE FOR LOT NUMBER 091209. CONCLUSION: ALL BREATHING CIRCUITS ARE TESTED FOR CONNECTIVITY AND ELECTRICAL CONTINUITY DURING PRODUCTION AND THOSE THAT FAILED 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).

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED VIA A DISTRIBUTOR THAT AN RT200 ADULT DUAL HEATED BREATHING CIRCUIT HAD BENT PINS. THE HOSPITAL NOTICED THAT THE HEATER WIRE PINS WERE BENT PRIOR TO PATIENT USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ADULT DUAL HEATED BREATHING CIRCUIT BTT FISHER & PAYKEL HEALTHCARE, LTD. RT200 091209

    Patients

    Seq Age Sex Outcome Treatment
    1