BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFANT BIAS FLOW DUAL-HEATED EVAQUA BREATHING CIRCUIT

    MDR report key: 2213667 · Received August 16, 2011

    Report

    Report Number
    9611451-2011-00497
    Event Type
    Malfunction
    Date Received
    August 16, 2011
    Report Date
    July 21, 2011
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LTD
    Product Code
    BZE
    PMA / PMN Number
    K034026
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE RETURNED COMPLAINT BREATHING CIRCUIT WAS VISUALLY INSPECTED AND PRESSURE TESTED. THE VISUAL INSPECTION REVEALED NO PHYSICAL DAMAGE TO THE COMPLAINT DEVICE. THE PRESSURE TEST REVEALED THE PRESSURE DROP TO BE WITHIN SPECIFICATION FOR THIS PRODUCT. NO FAULT WAS FOUND WITH THE RETURNED COMPLAINT BREATHING CIRCUIT. ALL CIRCUITS ARE PRESSURE AND FLOW TESTED BEFORE THEY ARE ALLOWED TO LEAVE THE PRODUCTION LINE. THIS IS (B)(4) ANY THAT FAIL THESE TESTS ARE DISCARDED. OUR USER INSTRUCTIONS THAT ACCOMPANY THE RT235 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 THAT THE SWIVEL CONNECTOR OF AN RT235 INFANT BIAS FLOW DUAL-HEATED EVAQUA BREATHING CIRCUIT WAS "LEAKY". THIS WAS FOUND PRIOR TO PATIENT USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INFANT BIAS FLOW DUAL-HEATED EVAQUA BREATHING CIRCUIT BZE BZE FISHER & PAYKEL HEALTHCARE LTD RT235 110406

    Patients

    Seq Age Sex Outcome Treatment
    1