BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFANT LOW FLOW BREATHING CIRCUIT

    MDR report key: 1063701 · Received June 20, 2008

    Report

    Report Number
    9611451-2008-00376
    Event Type
    Malfunction
    Date Received
    June 20, 2008
    Report Date
    May 28, 2008
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LTD.
    Product Code
    BTT
    PMA / PMN Number
    K020332
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THIS IS A MALFUNCTION THAT HAS BEEN REPORTED TO FISHER & PAYKEL HEALTHCARE BY A DISTRIBUTOR IN ANOTHER COUNTRY. THE PRODUCT IS NOT SOLD IN THE USA BUT IT IS SIMILAR TO A PRODUCT WHICH IS SOLD IN THE USA. THE RT226 INFANT LOW FLOW BREATHING CIRCUIT IS CURRENTLY EN ROUTE TO THE MFR FOR INVESTIGATION. NO RESULTS AND CONCLUSIONS ARE THEREFORE AVAILABLE AT PRESENT. A FOLLOW-UP REPORT WILL BE PREPARED AND FORWARD AS SOON AS THE DEVICE HAS BEEN RETURNED AND INVESTIGATION RESULTS BECOME AVAILABLE.

    Description of Event or Problem · 1

    OUR DISTRIBUTOR IN ANOTHER COUNTRY, REPORTED THAT AN RT226 INFANT LOW FLOW BREATHING CIRCUIT DID NOT PASS THE VENTILATOR LEAK TEST WHEN CONNECTED TO A SERVO I VENTILATOR DURING SET-UP. NO PT CONSEQUENCE WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INFANT LOW FLOW BREATHING CIRCUIT BTT FISHER & PAYKEL HEALTHCARE LTD. RT226

    Patients

    Seq Age Sex Outcome Treatment
    1 SERVO I VENTILATOR