BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADULT DUAL HEATED BREATHING CIRCUIT

    MDR report key: 1727564 · Received June 18, 2010

    Report

    Report Number
    9611451-2010-00384
    Event Type
    Malfunction
    Date Received
    June 18, 2010
    Date of Event
    May 18, 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

    Narratives

    Additional Manufacturer Narrative · 1

    THE ELECTRICAL RESISTANCE OF THE HEATER WIRE IN THE INSPIRATORY AND EXPIRATORY TUBES OF THE RETURNED BREATHING CIRCUIT WERE TESTED USING A MULTIMETER. RESULTS: THE HEATER WIRE RESISTANCE OF BOTH INSPIRATORY AND EXPIRATORY LIMBS WAS WITHIN SPECIFICATION. A LOT CHECK REVEALED NO OTHER COMPLAINTS OF THIS NATURE FOR LOT NUMBER 091202. CONCLUSION: ELECTRICAL OPEN CIRCUITS IN HEATER WIRES ARE OFTEN ASSOCIATED WITH IMPROPER CRIMPING OF THE HEATER WIRE DURING PRODUCTION. ALL BREATHING CIRCUITS ARE ELECTRICALLY TESTED DURING PRODUCTION AND THOSE THAT FAIL ARE REJECTED. (B)(4).

    Additional Manufacturer Narrative · 1

    THE RT204 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 THAT PRODUCT IS K983112. THE DEVICE IS CURRENTLY ON ITS WAY TO (B)(4). WE WILL PROVIDE A FOLLOW UP REPORT ON RECEIPT OF THE DEVICE AND COMPLETION OF OUR INVESTIGATION.

    Description of Event or Problem · 1

    THE FACILITY REPRESENTATIVE REPORTED TO BAXTER GLOBAL TECHNICAL SERVICES ONE COLLEAGUE INFUSION PUMP IN WHICH FAILURE CODE 403:317:871:0000 OCCURRED DURING THERAPY. THE REPORTED CONDITION OCCURRED IN THE MED. SURGERY. ACCORDING TO THE HOSPITAL REPRESENTATIVE, NO PATIENT INJURY OR MEDICAL INTERVENTION HAD BEEN REPORTED RELATED TO THIS DEVICE. NO ADDITIONAL INFORMATION IS AVAILABLE.THIS DEVICE UTILIZES USER INTERFACE MODULE MASTER SOFTWARE VERSION 6.13.90 CATEGORIZED AS REMEDIATED.

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED VIA OUR DISTRIBUTOR THAT THEY FOUND AN RT204 ADULT HEATED BREATHING CIRCUIT TO BE OPEN CIRCUIT BEFORE USE ON A PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ADULT DUAL HEATED BREATHING CIRCUIT BTT BTT FISHER & PAYKEL HEALTHCARE LTD RT204 091202

    Patients

    Seq Age Sex Outcome Treatment
    1