BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFANT LOW FLOW BREATHING CIRCUIT

    MDR report key: 1438794 · Received May 12, 2009

    Report

    Report Number
    9611451-2009-00234
    Event Type
    Malfunction
    Date Received
    May 12, 2009
    Date of Event
    April 8, 2009
    Report Date
    April 15, 2009
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LTD.
    Product Code
    BTT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE PRODUCT REFERRED TO IN THE COMPLAINT 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 RT126 INFANT LOW FLOW BREATHING CIRCUIT IS EN ROUTE TO FISHER & PAYKEL HEALTHCARE FOR INVESTIGATION. WE WILL PROVIDE A FOLLOW-UP REPORT UPON COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 1

    A DISTRIBUTOR IN (B)(4) REPORTED THAT A PART FROM THE CONNECTOR KIT BAG OF AN RT126 INFANT BREATHING CIRCUIT WAS MISSING. THIS WAS NOTICED DURING THEIR INWARD GOODS INSPECTION. NO PATIENT 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. RT126 090213

    Patients

    Seq Age Sex Outcome Treatment
    1