BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADULT BREATHING CIRCUIT

    MDR report key: 1220360 · Received October 31, 2008

    Report

    Report Number
    9611451-2008-00645
    Event Type
    Malfunction
    Date Received
    October 31, 2008
    Date of Event
    September 10, 2008
    Report Date
    October 2, 2008
    Manufacturer
    FISHER & PAYKEL HEALTHCARE, LTD.
    Product Code
    BTT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT REFERRED TO IN THE EVENT DESCRIPTION IS NOT SOLD IN THE USA BUT A SIMILAR PRODUCT IS SOLD IN THE USA. THE RETURNED CIRCUIT WAS VISUALLY INSPECTED FOR BENT PINS AND TESTED TO SEE IF IT COULD BE CONNECTED TO A HEATERWIRE PLUG. RESULTS: A HEATERWIRE ADAPTOR COULD NOT BE CONNECTED TO THE HEATERWIRE SOCKET IN THE EXPIRATORY TUBE. A VISUAL INSPECTION REVEALED THAT ONE OF THE HEATERWIRE PINS IN THE EXPIRATORY TUBE WAS BENT. THIS PREVENTS THE ADAPTOR FROM CONNECTING TO THE HEATERWIRE SOCKET. A LOT CHECK REVEALED NO OTHER SIMILAR COMPLAINTS FOR THIS LOT NUMBER. CONCLUSION: OUR MONITORING AND TRENDING FOR THIS TYPE OF EVENT HAS A RATE OF OCCURRENCE WORLDWIDE FOR THE LAST YEAR OF 24 PPM.

    Description of Event or Problem · 1

    A HEALTHCARE FACILITY IN AUSTRALIA REPORTED THAT AN RT200 ADULT BREATHING CIRCUIT COULD NOT BE CONNECTED TO THE HEATERWIRE ADAPTOR AS THE HEATERWIRE PINS IN THE EXPIRATORY TUBE WERE BENT. NO PATIENT CONSEQUENCE WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ADULT BREATHING CIRCUIT BTT FISHER & PAYKEL HEALTHCARE, LTD. RT200 080711

    Patients

    Seq Age Sex Outcome Treatment
    1