BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADULT DUAL-HEATED EVAQUA BREATHING CIRCUIT

    MDR report key: 1713883 · Received May 27, 2010

    Report

    Report Number
    9611451-2010-00306
    Event Type
    Malfunction
    Date Received
    May 27, 2010
    Report Date
    April 30, 2010
    Manufacturer
    FISHER & PAYKEL HEALTHCARE, LTD.
    Product Code
    BZE
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE RT340 ADULT DUAL-HEATED EVAQUA BREATHING CIRCUIT IS NOT SOLD IN THE USA BUT IT IS SIMILAR TO A PRODUCT SOLD IN THE USA. THE 510 (K) FOR THAT PRODUCT IS K983112. THE COMPLAINT BREATHING CIRCUITS ARE CURRENTLY EN ROUTE TO FISHER & PAYKEL HEALTHCARE FOR EVALUATION. 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 TWO (2) RT340 ADULT DUAL-HEATED EVAQUA BREATHING CIRCUITS LEAKED. NO PATIENT CONSEQUENCES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ADULT DUAL-HEATED EVAQUA BREATHING CIRCUIT BZE FISHER & PAYKEL HEALTHCARE, LTD. RT340 100330

    Patients

    Seq Age Sex Outcome Treatment
    1