BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADULT DUAL HEATED EVAQUA BREATHING CIRCUIT

    MDR report key: 3528577 · Received December 19, 2013

    Report

    Report Number
    9611451-2013-01059
    Event Type
    Malfunction
    Date Received
    December 19, 2013
    Date of Event
    November 26, 2013
    Report Date
    December 4, 2013
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LIMITED
    Product Code
    BZE
    PMA / PMN Number
    K983112
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). LOT NUMBER: MANUFACTURING DATE: QUANTITY AFFECTED: 130524, 05/24/2013, (B)(4); UNKNOWN, UNKNOWN, (B)(4). THE COMPLAINT RT340 ADULT DUAL HEATED EVAQUA BREATHING CIRCUITS ARE EN ROUTE TO FISHER & PAYKEL HEALTHCARE IN (B)(4) FOR INVESTIGATION. WE WILL PROVIDE A FOLLOW-UP REPORT ONCE WE HAVE COMPLETED OUR INVESTIGATION.

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED TO A DISTRIBUTOR THAT THREE RT340 ADULT DUAL HEATED EVAQUA BREATHING CIRCUITS FAILED THE VENTILATOR LEAK TEST. THIS WAS OBSERVED BEFORE USE ON A PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    667678 ADULT DUAL HEATED EVAQUA BREATHING CIRCUIT BZE BZE FISHER & PAYKEL HEALTHCARE LIMITED RT340 SEE H10

    Patients

    Seq Age Sex Outcome Treatment
    1