BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADULT DUAL HEATED EVAQUA BREATHING CIRCUIT

    MDR report key: 2493395 · Received March 15, 2012

    Report

    Report Number
    9611451-2012-00154
    Event Type
    Malfunction
    Date Received
    March 15, 2012
    Date of Event
    February 15, 2012
    Report Date
    February 16, 2012
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LTD
    Product Code
    BZE
    PMA / PMN Number
    SEE H.10
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE RT340 ADULT DUAL-HEATED EVAQUA 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 K983112. THE COMPLAINT DEVICE IS EN ROUTE TO THE MANUFACTURER. WE WILL PROVIDE A FOLLOW UP LETTER UPON COMPLETION OF OUR INVESTIGATION.

    Additional Manufacturer Narrative · 1

    (B)(4). THE RT340 ADULT DUAL-HEATED EVAQUA 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 K983112. METHOD: THE COMPLAINT BREATHING CIRCUIT WAS RETURNED TO THE MANUFACTURER AND VISUALLY INSPECTED AND PRESSURE TESTED. RESULTS: THERE WERE NO DAMAGES OBSERVED ON THE COMPLAINT BREATHING CIRCUIT. THE PRESSURE TEST REVEALED THE COMPLAINT BREATHING CIRCUIT TO BE WITHIN SPECIFICATION FOR THIS PRODUCT. CONCLUSION: NO FAULT WAS FOUND WITH THE RETURNED COMPLAINT BREATHING CIRCUIT. ALL RT340 BREATHING CIRCUITS ARE PRESSURE TESTED FOR LEAKS PRIOR TO DISTRIBUTION AND THOSE THAT FAIL ARE REJECTED. THE USER INSTRUCTIONS SUPPLIED WITH THE RT340 BREATHING CIRCUIT STATE: 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 RT340 ADULT DUAL HEATED EVAQUA BREATHING CIRCUIT FAILED THE VENTILATOR LEAK TEST BEFORE USE.

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED THAT AN RT340 ADULT DUAL HEATED EVAQUA BREATHING CIRCUIT FAILED THE VENTILATOR LEAK TEST BEFORE USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ADULT DUAL HEATED EVAQUA BREATHING CIRCUIT BZE BZE FISHER & PAYKEL HEALTHCARE LTD RT340

    Patients

    Seq Age Sex Outcome Treatment
    1