BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    9611451-2007-00185

    MDR report key: 881951 · Received July 19, 2007

    Report

    Report Number
    9611451-2007-00185
    Event Type
    Malfunction
    Date Received
    July 19, 2007
    Date of Event
    June 8, 2007
    Report Date
    June 13, 2007
    Manufacturer
    FISHER & PAYKEL HEALTHCARE, LTD.
    Product Code
    BTT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THIS IS A MALFUNCTION THAT HAS BEEN REPORTED TO FISHER & PAYKEL HEALTHCARE BY A DISTRIBUTOR. 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 THAT PRODUCT IS K020332. WE ARE AWAITING THE RETURN OF THE COMPLAINT DEVICE TO COMPLETE OUR INVESTIGATION.. RESULTS - INVESTIGATION STILL UNDERWAY, NO RESULTS TO DATE. CONCLUSION - NO CONCLUSION CAN BE MADE AT THIS TIME.

    Description of Event or Problem · 1

    REPORTER REPORTED THAT THE BLUE BREATHING TUBE ON THE RT225 CIRCUIT WAS FOUND WITH A CRACK IN IT. THIS WAS DISCOVERED DURING AN INWARDS GOODS INSPECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BTT FISHER & PAYKEL HEALTHCARE, LTD. RT225 070131

    Patients

    Seq Age Sex Outcome Treatment
    1 YR