BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    9611451-2007-00335

    MDR report key: 914869 · Received September 19, 2007

    Report

    Report Number
    9611451-2007-00335
    Event Type
    Malfunction
    Date Received
    September 19, 2007
    Report Date
    August 20, 2007
    Manufacturer
    FISHER & PAYKEL HEALTHCARE, LTD.
    Product Code
    BTT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EI
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS IS A MALFUNCTION THAT HAS BEEN REPORTED TO FISHER AND PAYKEL HEALTHCARE BY A HOSPITAL IN IRELAND. 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. THE COMPLAINT DEVICE HAS NOT YET BEEN RETURNED. WE WILL COMPLETE OUR INVESTIGATION ON RECEIPT OF THE DEVICE.

    Description of Event or Problem · 1

    WE RECEIVED A REPORT, STATING THAT CIRCUITS WERE LEAKING FROM THE SWIVEL JOINT ON AN RT226 NEONATAL HEATED BREATING CIRCUIT. THEY CONFIRM THAT THERE WAS NO PATIENT CONSEQUENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BTT FISHER & PAYKEL HEALTHCARE, LTD. RT226 070405

    Patients

    Seq Age Sex Outcome Treatment
    1 YR