BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADULT DUAL HEATED BREATHING CIRCUIT

    MDR report key: 1735869 · Received June 21, 2010

    Report

    Report Number
    9611451-2010-00386
    Event Type
    Malfunction
    Date Received
    June 21, 2010
    Report Date
    May 18, 2010
    Manufacturer
    FISHER & PAYKEL HEALTHCARE, LTD.
    Product Code
    BTT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ADD'L LOT #: 091223, ADD'L DATE OF MANUFACTURE: 12/23/2009, QUANTITY: 2. 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 CIRCUITS WERE TESTED FOR BENT PINS. RESULTS: AN INSPIRATORY HEATER WIRE PIN ON EACH OF THE COMPLAINT BREATHING CIRCUITS WAS BENT, PREVENTING FULL INSERTION OF A HEATER WIRE ADAPTOR AND CONFIRMING THE REPORTED FAULTS. A LOT CHECK REVEALED ONE OTHER COMPLAINT OF THIS NATURE FOR LOT NUMBER 091209 AND NO OTHER COMPLAINTS OF THIS NATURE FOR LOT NUMBER 091223. 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 PT, 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 THREE RT200 ADULT DUAL HEATED BREATHING CIRCUITS HAD BENT PINS. THE BENT PINS WERE OBSERVED BY THE HOSPITAL PRIOR TO PT 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