BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFANT DUAL HEATED EVAQUA BREATHING CIRCUIT

    MDR report key: 4522009 · Received February 17, 2015

    Report

    Report Number
    9611451-2015-00083
    Event Type
    Malfunction
    Date Received
    February 17, 2015
    Report Date
    January 19, 2015
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LIMITED
    Product Code
    BZE
    PMA / PMN Number
    K034026
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). WE ARE CURRENTLY IN THE PROCESS OF OBTAINING THE COMPLAINT RT236 INFANT DUAL-HEATED EVAQUA BREATHING CIRCUIT FROM THE DISTRIBUTOR. WE WILL PROVIDE A FOLLOW-UP REPORT ONCE WE HAVE RECEIVED THE COMPLAINT DEVICE AND COMPLETED OUR INVESTIGATION.

    Additional Manufacturer Narrative · 1

    (B)(4). THE COMPLAINT RT236 INFANT DUAL-HEATED EVAQUA BREATHING CIRCUIT WAS NOT RETURNED TO FISHER & PAYKEL HEALTHCARE FOR INSPECTION. WITHOUT THE COMPLAINT DEVICE, WE ARE UNABLE TO CONFIRM THE REPORTED FAULT AND DETERMINE ITS ROOT CAUSE. A LOT CHECK REVEALED NO OTHER COMPLAINTS OF THIS NATURE FOR LOT NUMBER 140911. THE HOSPITAL REPORTED THAT THE SUBJECT BREATHING CIRCUIT PASSED THE INITIAL LEAK TEST AND THAT THE SWIVEL Y-PIECE BECAME DISCONNECTED WHILE THE BREATHING CIRCUIT WAS BEING HANDLED. IT WAS ALSO REPORTED THAT NO DAMAGE WAS OBSERVED TO THE SWIVEL Y-PIECE. ALL RT236 INFANT DUAL-HEATED EVAQUA BREATHING CIRCUITS, INCLUDING THE SWIVEL ASSEMBLIES, ARE VISUALLY INSPECTED AND PRESSURE AND FLOW TESTED DURING PRODUCTION. THOSE THAT FAIL ARE REJECTED. THE HOSPITAL STAFF CONFIRMED THAT THE SUBJECT BREATHING CIRCUIT WAS IN USE BEFORE THE EVENT OCCURRED, WHICH INDICATES THAT THE CIRCUIT BECAME DAMAGED DURING USE. OUR USER INSTRUCTIONS THAT ACCOMPANY THE RT236 INFANT DUAL-HEATED EVAQUA BREATHING CIRCUIT STATE THE FOLLOWING: "CHECK ALL CONNECTIONS ARE TIGHT BEFORE USE." "PERFORM A PRESSURE AND LEAK TEST ON THE BREATHING SYSTEM AND CHECK FOR OCCLUSIONS BEFORE CONNECTING TO A PATIENT." "SET APPROPRIATE VENTILATOR ALARMS."

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED VIA A DISTRIBUTOR THAT THE SWIVEL Y-PIECE OF AN RT236 INFANT DUAL-HEATED EVAQUA BREATHING CIRCUIT BECAME DISCONNECTED DURING USE. NO PATIENT CONSEQUENCE WAS REPORTED.

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED VIA A DISTRIBUTOR THAT THE SWIVEL Y-PIECE OF AN RT236 INFANT DUAL-HEATED EVAQUA BREATHING CIRCUIT BECAME DISCONNECTED DURING USE. NO PATIENT CONSEQUENCE WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    114323 INFANT DUAL HEATED EVAQUA BREATHING CIRCUIT BZE BZE FISHER & PAYKEL HEALTHCARE LIMITED RT236 140911

    Patients

    Seq Age Sex Outcome Treatment
    1