BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFANT DUAL HEATED EVAQUA2 BREATHING CIRCUIT

    MDR report key: 5503126 · Received March 15, 2016

    Report

    Report Number
    9611451-2016-00096
    Event Type
    Malfunction
    Date Received
    March 15, 2016
    Date of Event
    February 15, 2016
    Report Date
    February 15, 2016
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LTD
    Product Code
    BZE
    PMA / PMN Number
    SEE H10
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE RT268 INFANT DUAL-HEATED 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 RT268 BREATHING CIRCUIT WAS RETURNED TO FISHER & PAYKEL HEALTHCARE. VISUAL INSPECTION OF THE CIRCUIT WAS PERFORMED. RESULTS:A CUT WAS FOUND IN THE INSPIRATORY LIMB OF THE RT268 BREATHING CIRCUIT. A LOT CHECK REVEALED NO OTHER COMPLAINTS FOR THE LOT NUMBER PROVIDED. CONCLUSION: IT APPEARS THAT THE INSPIRATORY LIMB OF THE RT268 BREATHING CIRCUIT WAS CUT WITH A SHARP OBJECT, WHICH MAY HAVE OCCURED WHEN OPENING THE DEVICE BOX/BAG WITH A SHARP OBJECT SUCH AS A KNIFE OR BOX CUTTER. THE ALSO CUSTOMER CONFIRMED THE USE OF A UTILITY KNIFE TO OPEN THE CIRCUIT KIT. OUR USER INSTRUCTIONS THAT ACCOMPANY THE RT268 STATE THE FOLLOWING: 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 TO A FISHER & PAYKEL HEALTHCARE FIELD REPRESENTATIVE THAT THE INSPIRATORY LIMB OF AN RT268 INFANT BREATHING CIRCUIT BROKE AND THAT WATER WAS LEAKING FROM IT. THIS WAS OBSERVED BEFORE USE ON A PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    158005 INFANT DUAL HEATED EVAQUA2 BREATHING CIRCUIT BZE BZE FISHER & PAYKEL HEALTHCARE LTD RT268 150907

    Patients

    Seq Age Sex Outcome Treatment
    1