BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFANT DUAL-HEATED EVAQUA BREATHING CIRCUIT

    MDR report key: 3225770 · Received July 14, 2013

    Report

    Report Number
    9611451-2013-00529
    Event Type
    Malfunction
    Date Received
    July 14, 2013
    Report Date
    June 19, 2013
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LTD
    Product Code
    BZE
    PMA / PMN Number
    K034026
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE COMPLAINT RT235 CIRCUIT IS CURRENTLY EN ROUTE TO FISHER & PAYKEL HEALTHCARE FOR EVALUATION. WE WILL PROVIDE A FOLLOW UP REPORT UPON COMPLETION OF OUR INVESTIGATION.

    Additional Manufacturer Narrative · 1

    (B)(4) METHOD: THE RETURNED COMPLAINT RT235 BREATHING CIRCUIT WAS VISUALLY INSPECTED AND PRESSURE TESTED FOR THE REPORTED LEAK. RESULTS: THE PRESSURE TEST REVEALED THAT THE RT235 CIRCUIT WAS WITHIN SPECIFICATION AND WAS NOT LEAKING. A LOT CHECK REVEALED NO OTHER COMPLAINTS FOR LOT 130305. CONCLUSION: WE WERE UNABLE TO DETERMINE WHAT CAUSED THE LEAK REPORTED BY THE CUSTOMER AS OUR TESTING CONFIRMED THAT THERE WAS NO DEFECT WITH THE SUBJECT BREATHING CIRCUIT. THE USER INSTRUCTIONS THAT ACCOMPANY THE RT235 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 ALARM." (B)(4).

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED THAT AN RT235 INFANT BREATHING CIRCUIT HAD A LEAK. THIS WAS FOUND DURING THE VENTILATOR LEAK TEST, BEFORE PATIENT USE.

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED THAT AN RT235 INFANT BREATHING CIRCUIT HAD A LEAK. THIS WAS FOUND DURING THE VENTILATOR LEAK TEST, BEFORE PATIENT USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    325273 INFANT DUAL-HEATED EVAQUA BREATHING CIRCUIT BZE BZE FISHER & PAYKEL HEALTHCARE LTD RT235 130305

    Patients

    Seq Age Sex Outcome Treatment
    1