BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADULT DUAL HEATED BREATHING CIRCUIT

    MDR report key: 1939957 · Received December 28, 2010

    Report

    Report Number
    9611451-2010-00791
    Event Type
    Malfunction
    Date Received
    December 28, 2010
    Report Date
    December 1, 2010
    Manufacturer
    FISHER & PAYKEL HEALTHCARE
    Product Code
    BTT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). METHOD: THE BREATHING CIRCUIT WAS CHECKED FOR BENT OR BROKEN HEATER WIRE PINS. RESULTS: ONE OF THE INSPIRATORY HEATER WIRE PINS WAS SPLIT, PREVENTING FULL INSERTION OF A HEATER WIRE ADAPTOR. A LOT CHECK REVEALED NO OTHER COMPLAINTS OF THIS NATURE FOR LOT NUMBER 100412. 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 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. 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 DISTRIBUTOR IN (B)(6) REPORTED THAT AN RT200 ADULT BREATHING CIRCUIT HAD A BROKEN HEATER WIRE PIN. THE BROKEN PIN WAS FOUND BY THE DISTRIBUTOR 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 RT200 100412

    Patients

    Seq Age Sex Outcome Treatment
    1