BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFANT BINS FLOW BREATHING CIRCUIT

    MDR report key: 927364 · Received April 5, 2007

    Report

    Report Number
    9611451-2007-00104
    Event Type
    Malfunction
    Date Received
    April 5, 2007
    Report Date
    March 12, 2007
    Manufacturer
    FISHER & PAYKEL HEALTHCARE, LTD.
    Product Code
    BTT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    INVALID DATA

    Narratives

    Additional Manufacturer Narrative · 1

    THIS IS A MALFUNCTION THAT HAS BEEN REPORTED TO FISHER & PAYKEL HEALTHCARE BY A DISTRIBUTOR IN JAPAN. THE PROD IS NOT SOLD IN USA BUT IT IS SIMILAR TO A PROD WHICH IS SOLD IN THE USA. THE 510(K) FOR THAT DEVICE IS K020332. THE DEVICE IS EXPECTED TO BE RETURNED TO FISHER & PAYKEL HEALTHCARE. NO INFORMATION TO DATE. INVESTIGATION IS STILL UNDERWAY, NO RESULTS TO DATE. NO CONCLUSION CAN BE MADE AT THIS TIME.

    Description of Event or Problem · 1

    A HOSP IN A FOREIGN COUNTRY REPORTED TO OUR DISTRIBUTOR THAT A PORT CAP IS MISSING FROM THE HUMIDIFIER CONNECTION TUBE OF AN RT125 INFANT BREATHING CIRCUIT. NO PT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INFANT BINS FLOW BREATHING CIRCUIT BTT BTT FISHER & PAYKEL HEALTHCARE, LTD. RT125 060316

    Patients

    Seq Age Sex Outcome Treatment
    1 *