BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADULT DUAL HEATED EVAQUA BREATHING CIRCUIT

    MDR report key: 1619184 · Received February 24, 2010

    Report

    Report Number
    9611451-2010-00094
    Event Type
    Malfunction
    Date Received
    February 24, 2010
    Date of Event
    January 2, 2010
    Report Date
    January 26, 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 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 DEVICE IS CURRENTLY EN ROUTE TO THE MANUFACTURER. WE WILL PROVIDE A FOLLOW UP REPORT ONCE WE HAVE RECEIVED THE DEVICE AND CARRIED OUT AN INVESTIGATION.

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED AN RT340 ADULT DUAL HEATED EVAQUA BREATHING CIRCUIT LEAKED DURING USE IN THE INTENSIVE CARE UNIT. NO PATIENT CONSEQUENCE WAS 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

    Patients

    Seq Age Sex Outcome Treatment
    1