BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFANT DUAL-HEATED EVAQUA BREATHING CIRCUIT

    MDR report key: 1930849 · Received December 16, 2010

    Report

    Report Number
    9611451-2010-00753
    Event Type
    Malfunction
    Date Received
    December 16, 2010
    Date of Event
    November 16, 2010
    Report Date
    November 19, 2010
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LIMITED
    Product Code
    BZE
    PMA / PMN Number
    K034026
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EI
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE COMPLAINT BREATHING CIRCUITS HAVE NOT YET BEEN RETURNED TO FISHER & PAYKEL HEALTHCARE FOR EVALUATION. WE WILL SUBMIT A FOLLOW-UP REPORT UPON RECEIPT OF THE BREATHING CIRCUITS AND COMPLETION OF OUR INVESTIGATION.

    Additional Manufacturer Narrative · 1

    (B)(4). IT WAS REPORTED THAT THE THREE COMPLAINT BREATHING CIRCUITS WOULD BE RETURNED TO FISHER & PAYKEL HEALTHCARE (B)(4) FOR INVESTIGATION. UNFORTUNATELY THE DEVICES WERE LOST IN TRANSIT FROM (B)(4) TO FISHER & PAYKEL HEALTHCARE'S REGIONAL OFFICE AND SERVICE CENTER IN THE (B)(4). AS THE COMPLAINT DEVICES ARE NO LONGER AVAILABLE FOR INVESTIGATION, WE ARE UNABLE TO CONFIRM OR DETERMINE THE ROOT CAUSE OF THE REPORTED SWIVEL LEAK. (B)(4).

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED VIA A FISHER & PAYKEL HEALTHCARE REPRESENTATIVE THAT THREE RT236 BREATHING CIRCUITS WERE LEAKING FROM THE WYE-PIECE (SWIVEL). THE LEAKS WERE IDENTIFIED BY THE HOSPITAL PRIOR TO PATIENT USE.

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED VIA A FISHER & PAYKEL HEALTHCARE REPRESENTATIVE THAT THREE RT236 BREATHING CIRCUITS WERE LEAKING FROM THE WYE-PIECE (SWIVEL). THE LEAKS WERE IDENTIFIED BY THE HOSPITAL PRIOR TO PATIENT USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INFANT DUAL-HEATED EVAQUA BREATHING CIRCUIT BZE BZE FISHER & PAYKEL HEALTHCARE LIMITED RT236 100629

    Patients

    Seq Age Sex Outcome Treatment
    1