BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADULT HEATED BREATHING CIRCUIT

    MDR report key: 1651092 · Received March 31, 2010

    Report

    Report Number
    9611451-2010-00194
    Event Type
    Malfunction
    Date Received
    March 31, 2010
    Date of Event
    March 1, 2010
    Report Date
    March 1, 2010
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LTD
    Product Code
    BTT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THIS 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 K983112. THE RT443 ADULT HEATED BREATHING CIRCUIT IS EN ROUTE TO FISHER & PAYKEL HEALTHCARE FOR INVESTIGATION. WE WILL PROVIDE A FOLLOW-UP REPORT UPON COMPLETION OF OUR INVESTIGATION.

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED THAT THREE RT443 ADULT BREATHING CIRCUIT PACKS WERE MISSING THE PRESSURE LINE ADAPTOR KITS. THIS WAS FOUND BEFORE USE ON A PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ADULT HEATED BREATHING CIRCUIT BTT FISHER & PAYKEL HEALTHCARE LTD RT443 090428

    Patients

    Seq Age Sex Outcome Treatment
    1