BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADULT DUAL-HEATED BREATHING CIRCUIT

    MDR report key: 2182713 · Received July 28, 2011

    Report

    Report Number
    9611451-2011-00454
    Event Type
    Malfunction
    Date Received
    July 28, 2011
    Report Date
    July 1, 2011
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LIMITED
    Product Code
    BTT
    PMA / PMN Number
    REFER TO H10
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE RT200 ADULT DUAL-HEATED BREATHING CIRCUIT IS NOT SOLD IN THE USA BUT IT IS SIMILAR TO A PRODUCT WHICH IS SOLD IN THE USA. THE 510(K) FOR THE SIMILAR PRODUCT IS K983112. METHOD: THE INSPIRATORY AND EXPIRATORY HEATER WIRES OF THE RETURNED RT200 ADULT BREATHING CIRCUIT WAS VISUALLY INSPECTED FOR DAMAGED PINS AND TESTED TO SEE IF IT COULD BE CONNECTED TO A HEATER WIRE ADAPTOR. RESULTS: NO FAULT WAS FOUND WITH THE HEATER WIRE IN THE EXPIRATORY TUBE. HOWEVER, A HEATER WIRE ADAPTOR COULD NOT BE CONNECTED TO THE HEATER WIRE SOCKET IN THE INSPIRATORY TUBE. A VISUAL INSPECTION REVEALED THAT THE HEATER WIRE PIN WAS SPLIT. A LOT CHECK REVEALED NO OTHER COMPLAINTS OF THIS NATURE FOR LOT NUMBER 101213. CONCLUSION: IT IS POSSIBLE FOR THE USER TO DAMAGE THE HEATER WIRE PINS DURING USE, PARTICULARLY IF THE HEATER WIRE ADAPTOR IS INSERTED INTO THE HEATER WIRE PLUG ON AN ANGLE. FOR BENT OR SPLIT 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. (B)(4).

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED THAT AN RT200 ADULT DUAL-HEATED BREATHING CIRCUIT HAD BROKEN HEATER WIRE PIN. THIS WAS NOTICED PRIOR TO PATIENT USE. NO PATIENT CONSEQUENCE WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ADULT DUAL-HEATED BREATHING CIRCUIT BTT BTT FISHER & PAYKEL HEALTHCARE LIMITED RT200 101213

    Patients

    Seq Age Sex Outcome Treatment
    1