BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADULT DUAL HEATED BREATHING CIRCUIT

    MDR report key: 1502838 · Received September 15, 2009

    Report

    Report Number
    9611451-2009-00491
    Event Type
    Malfunction
    Date Received
    September 15, 2009
    Report Date
    August 27, 2009
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LTD
    Product Code
    BTT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THIS IS A MALFUNCTION THAT HAS BEEN REPORTED TO FISHER & PAYKEL HEALTHCARE BY A HOSPITAL IN (B)(6). THE PRODUCT 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 BREATHING CIRCUIT NOT AVAILABLE FOR EVALUATION BECAUSE IT HAD BEEN DISCARDED BY THE HOSPITAL. AN INVESTIGATION WAS CONDUCTED BASED ON THE INFORMATION PROVIDED AND OUR KNOWLEDGE OF SIMILAR COMPLAINTS. RESULTS: BASED ON THE INFORMATION PROVIDED, THE HEATER WIRE IN THE BREATHING CIRCUIT WAS AN OPEN CIRCUIT. A LOT CHECK REVEALED NO SIMILAR COMPLAINTS FOR SIMILAR PRODUCTS WITH LOT NUMBER 090511. 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. THIS SUGGESTS THE HEATER WIRE BECAME AN OPEN CIRCUIT POST PRODUCTION. (B)(4).

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED THAT AN MR850 RESPIRATORY HUMIDIFIER GENERATED A HEATER WIRE OR TEMPERATURE PROBE ALARM AND "THE TEMPERATURE ON THE DISPLAY WAS AROUND 24 DEGREES C." THE STAFF REPLACED THE RT200 ADULT DUAL HEATED BREATHING CIRCUIT AND THE ALARM STOPPED AND "THE HUMIDIFIER OPERATED PROPERLY." NO PATIENT CONSEQUENCE WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ADULT DUAL HEATED BREATHING CIRCUIT BTT FISHER & PAYKEL HEALTHCARE LTD RT200 090511

    Patients

    Seq Age Sex Outcome Treatment
    1