BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFANT DUAL-HEATED EVAQUA2 BREATHING CIRCUIT

    MDR report key: 2559299 · Received May 4, 2012

    Report

    Report Number
    9611451-2012-00279
    Event Type
    Malfunction
    Date Received
    May 4, 2012
    Date of Event
    April 11, 2012
    Report Date
    April 11, 2012
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LIMITED
    Product Code
    BZE
    PMA / PMN Number
    REFER TO H10
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE RT265 INFANT EVAQUA2 BREATHING CIRCUIT IS NOT SOLD IN THE USA BUT IT IS SIMILAR TO A PRODUCT SOLD IN THE USA. THE 510(K) FOR THAT PRODUCT IS K034026. METHOD: THE COMPLAINT RT265 INFANT BREATHING CIRCUIT WAS RETURNED TO FISHER & PAYKE HEALTHCARE IN (B)(4) FOR INSPECTION. IT WAS VISUALLY INSPECTED AND PRESSURE TESTED. RESULTS: NO PHYSICAL DAMAGE WAS OBSERVED TO THE RETURNED BREATHING CIRCUIT. FURTHER INSPECTION REVEALED THAT THE LUER PORT CAP WAS MISSING FROM THE PRESSURE LINE PORT, CONFIRMING THE REPORTED FAULT. THE PRESSURE TEST RESULT WAS OUTSIDE OF THE REQUIRED SPECIFICATION. A LOT CHECK REVEALED ONE OTHER COMPLAINT OF THIS NATURE FOR LOT NUMBER 120125. CONCLUSION: ALL BREATHING CIRCUITS ARE VISUALLY INSPECTED AND PRESSURE TESTED PRIOR TO LEAVING THE PRODUCTION LINE AND THOSE THAT FAIL ARE REJECTED. HOWEVER, WE ARE UNABLE TO DETERMINE WHETHER THE SUBJECT LUER PORT CAP FELL OFF AT THE PRODUCTION LINE OR UPON OPENING OF THE RT265 KIT AT THE USER'S FACILITY. A LOT CHECK REVEALED ONE OTHER COMPLAINT OF THIS NATURE FOR INFANT BREATHING CIRCUITS IN THE PAST 12 MONTHS TO THE END OF APRIL 2012.

    Description of Event or Problem · 1

    A HOSPTIAL IN THE (B)(6) REPORTED THAT THE "WHITE CAP OF THE TUBING" OF AN RT265 INFANT DUAL-HEATED EVAQUA2 BREATHING CIRCUIT WAS MISSING. THIS WAS NOTICED PRIOR TO PATIENT USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INFANT DUAL-HEATED EVAQUA2 BREATHING CIRCUIT BZE BZE FISHER & PAYKEL HEALTHCARE LIMITED RT265 120125

    Patients

    Seq Age Sex Outcome Treatment
    1