BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFANT DUAL-HEATED EVAQUA2 BREATHING CIRCUIT

    MDR report key: 4738735 · Received April 30, 2015

    Report

    Report Number
    9611451-2015-00221
    Event Type
    Malfunction
    Date Received
    April 30, 2015
    Report Date
    March 31, 2015
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LTD
    Product Code
    BZE
    PMA / PMN Number
    K034026
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). METHOD: THE COMPLAINT RT266 INFANT BREATHING CIRCUIT WAS RETURNED TO FISHER & PAYKEL HEALTHCARE IN (B)(4) WHERE IT WAS VISUALLY INSPECTED AND PRESSURE TESTED FOR THE REPORTED PROBLEM. RESULTS: VISUAL INSPECTION REVEALED THAT THE SWIVEL WAS NOT FULLY SEATED IN THE SWIVEL ELBOW. NO DAMAGE WAS NOTED TO THE RETURNED DEVICES. THE INNER DIAMETER OF THE SWIVEL ELBOW AND OUTER DIAMETER OF THE SWIVEL WYE LIP WERE WITHIN SPECIFICATION. PRESSURE TEST REVEALED THE RETURNED SWIVEL WAS WITHIN SPECIFICATION AND THE SWIVEL DID NOT COME APART DURING THE PRESSURE TEST. A LOT CHECK REVEALED NO OTHER COMPLAINTS OF THIS NATURE FOR LOT 141215. CONCLUSION: WE ARE UNABLE TO DETERMINE WHAT MAY HAVE CAUSED THE PROBLEM REPORTED BY THE CUSTOMER. NO FAULT WAS FOUND WITH THE RETURNED RT266 INFANT DUAL-HEATED EVAQUA2 BREATHING CIRCUIT. 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 THE SWIVEL WYE OF AN RT266 INFANT DUAL HEATED EVAQUA2 BREATHING CIRCUIT WAS COMING APART WHEN CHANGING THE CIRCUIT POSITION. NO PATIENT CONSEQUENCE WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    285094 INFANT DUAL-HEATED EVAQUA2 BREATHING CIRCUIT BZE BZE FISHER & PAYKEL HEALTHCARE LTD RT266 141201

    Patients

    Seq Age Sex Outcome Treatment
    1