BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFANT DUAL HEATED EVAQUA2 BREATHING CIRCUIT

    MDR report key: 2766222 · Received October 1, 2012

    Report

    Report Number
    9611451-2012-00692
    Event Type
    Malfunction
    Date Received
    October 1, 2012
    Date of Event
    September 17, 2012
    Report Date
    September 17, 2012
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LTD
    Product Code
    BZE
    PMA / PMN Number
    SEE H10
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    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 BREATHING CIRCUIT WAS RETURNED TO THE MANUFACTURER. THE COMPLAINT BREATHING CIRCUIT WAS VISUALLY INSPECTED AND PRESSURE TESTED FOR LEAKS. RESULTS: NO DAMAGES WERE OBSERVED ON THE RETURNED COMPLAINT BREATHING CIRCUIT. THE PRESSURE TEST IDENTIFIED THE COMPLAINT BREATHING CIRCUIT TO BE WITHIN SPECIFICATION FOR THIS PRODUCT. NO FAULT FOUND. CONCLUSION: WE WERE UNABLE TO DETERMINE THE CAUSE OF THE PROBLEM AS REPORTED BY THE CUSTOMER, AS NO FAULT COULD BE FOUND WITH THE RETURNED COMPLAINT DEVICE. ALL RT268 BREATHING CIRCUITS ARE PRESSURE TESTED FOR LEAKS PRIOR TO DISTRIBUTION AND THOSE THAT FAIL ARE REJECTED. OUR USER INSTRUCTIONS THAT ACCOMPANY THE RT268 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 AN RT268 INFANT DUAL HEATED EVAQUA2 BREATHING CIRCUIT DID NOT PASS THE VENTILATOR LEAK TEST. THE HOSPITAL FURTHER REPORTED THAT A NEW CIRCUIT WAS USED AND THE PROBLEM WAS RESOLVED. THIS WAS REPORTED 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 LTD RT268 120622

    Patients

    Seq Age Sex Outcome Treatment
    1