BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFANT BIAS FLOW BREATHING CIRCUIT

    MDR report key: 1030343 · Received April 15, 2008

    Report

    Report Number
    9611451-2008-00183
    Event Type
    Malfunction
    Date Received
    April 15, 2008
    Report Date
    August 15, 2007
    Manufacturer
    FISHER & PAYKEL HEALTHCARE, LTD.
    Product Code
    BTT
    PMA / PMN Number
    K020332
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT IN THIS COMPLAINT IS NOT SOLD IN THE USA, BUT IT IS SIMILAR TO A PRODUCT WHICH IS SOLD IN THE USA. THE DEVICE WAS DISPOSED OF BY THE HEALTHCARE FACILITY. AN INVESTIGATION WAS CARRIED OUT BASED ON THE EVENT DESCRIPTION AND PREVIOUS EXPERIENCE FROM SIMILAR COMPLAINTS. RESULT: THERE ARE SEVERAL POSSIBLE EVENTS THAT COULD MANIFEST THEMSELVES IN THE STATED EVENT DESCRIPTION. IT IS LIKELY THAT THIS FAILURE HAS BEEN CAUSED BY POOR HEATER WIRE ELECTRICAL CONTINUITY. OUR MONITORING AND TRENDING FOR THIS TYPE OF EVENT SHOWS A RATE OF OCCURRENCE FOR THE PAST YEAR OF 0.0018%.

    Description of Event or Problem · 1

    A HEALTHCARE FACILITY REPORTED TO OUR DISTRIBUTOR THAT WHEN THE RT225 INFANT BIAS FLOW BREATHING CIRCUIT WAS USED WITH THE HUMIDIFIER CONTROLLER, AFTER 5 DAYS AN AIRWAY TEMPERATURE ALARM ON SOUNDED. THEY REPORTED THE BREATHING CIRCUIT WAS REPLACED WITH A NEW RT225, AND NO FURTHER PROBLEMS WERE ENCOUNTERED. NO PATIENT CONSEQUENCE WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INFANT BIAS FLOW BREATHING CIRCUIT BTT FISHER & PAYKEL HEALTHCARE, LTD. RT225 070727

    Patients

    Seq Age Sex Outcome Treatment
    1