BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFANT DUAL HEATED EVAQUA2 BREATHING CIRCUIT

    MDR report key: 4633744 · Received March 26, 2015

    Report

    Report Number
    9611451-2015-00163
    Event Type
    Malfunction
    Date Received
    March 26, 2015
    Report Date
    February 25, 2015
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LTD
    Product Code
    BZE
    PMA / PMN Number
    K103767
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE COMPLAINT BREATHING CIRCUITS ARE CURRENTLY EN ROUTE TO FISHER & PAYKEL HEALTHCARE IN (B)(4) FOR EVALUATION. WE WILL PROVIDE A FOLLOW UP REPORT UPON COMPLETION OF OUR INVESTIGATION.

    Additional Manufacturer Narrative · 1

    (B)(4). METHOD: FOUR RT266 BREATHING CIRCUITS, STILL SEALED IN THE ORIGINAL PACKAGING, WERE RETURNED TO FISHER & PAYKEL HEALTHCARE IN (B)(4). THE SWIVEL WAS ATTACHED TO THE WYE IN ALL RETURNED DEVICES. THE CIRCUITS WERE VISUALLY EXAMINED AND PRESSURE TESTED. RESULTS: VISUAL INSPECTION DID NOT REVEAL ANY DAMAGE TO THE RETURNED RT266 INFANT EVAQUA2 BREATHING CIRCUITS. THE SWIVEL WAS RETURNED FULLY SEATED IN THE SWIVEL ELBOW FOR ALL FOUR DEVICES AND THE SWIVELS ROTATED EASILY. PRESSURE TEST REVEALED THAT THE RETURNED CIRCUITS WERE WITHIN SPECIFICATION AND THE SWIVEL ELBOW DID NOT DISCONNECT FROM THE SWIVEL WYE DURING THE PRESSURE TEST. A LOT CHECK REVEALED NO OTHER COMPLAINTS OF THIS NATURE FOR LOT NUMBER 141126. CONCLUSION: WE ARE UNABLE TO DETERMINE WHAT MAY HAVE CAUSED THE REPORTED PROBLEM. NO FAULT WAS FOUND WITH THE RETURNED RT266 INFANT EVAQUA2 BREATHING CIRCUITS. ALL RT266 INFANT DUAL-HEATED EVAQUA2 BREATHING CIRCUITS ARE VISUALLY INSPECTED AND PRESSURE AND FLOW TESTED DURING PRODUCTION, AND THOSE THAT FAIL ARE REJECTED. THE USER INSTRUCTIONS THAT ACCOMPANY THE RT266 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 "A PIECE BETWEEN THE PATIENT ADAPTOR AND WYE OF THE BREATHING CIRCUITS OCCASIONALLY POPS OFF EASILY WHEN PROVIDERS MOVE THE PATIENT AND CIRCUIT." NO PATIENT CONSEQUENCE WAS REPORTED.

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6), REPORTED VIA A DISTRIBUTOR THAT "A PIECE BETWEEN THE PATIENT ADAPTOR AND WYE OF THE BREATHING CIRCUITS OCCASIONALLY POPS OFF EASILY WHEN PROVIDERS MOVE THE PATIENT AND CIRCUIT". NO PATIENT CONSEQUENCE WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    204445 INFANT DUAL HEATED EVAQUA2 BREATHING CIRCUIT BZE BZE FISHER & PAYKEL HEALTHCARE LTD RT266 141126

    Patients

    Seq Age Sex Outcome Treatment
    1