BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADULT DUAL-HEATED WITH EVAQUA BREATHING CIRCUIT

    MDR report key: 3103329 · Received May 9, 2013

    Report

    Report Number
    9611451-2013-00371
    Event Type
    Malfunction
    Date Received
    May 9, 2013
    Date of Event
    April 10, 2013
    Report Date
    April 12, 2013
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LTD
    Product Code
    BZE
    PMA / PMN Number
    REFER TO H10
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    NURSE

    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 RT340 CIRCUIT WAS RECENTLY RETURNED TO FISHER & PAYKEL HEALTHCARE (B)(4) FOR EVALUATION. OUR INVESTIGATION IS CURRENTLY ONGOING AND WE WILL PROVIDE A FOLLOW UP REPORT 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 RT340 BREATHING CIRCUIT WAS RETURNED TO FISHER & PAYKEL HEALTHCARE (FPH) (B)(4) AND VISUALLY INSPECTED. RESULTS: A HOLE WAS FOUND IN THE EVAQUA (EXPIRATORY) LIMB OF THE COMPLAINT BREATHING CIRCUIT, APPROXIMATELY 26 CM AWAY FROM THE PATIENT END CONNECTOR. CONCLUSION: BASED ON INSPECTION OF THE HOLE DAMAGE, IT IS LIKELY THAT THE EVAQUA EXPIRATORY LIMB WAS PUNCTURED OR SCRATCHED BY A BLUNT OBJECT. ALL RT340 BREATHING CIRCUITS ARE PRESSURE TESTED FOR LEAKS PRIOR TO BEING RELEASED FOR DISTRIBUTION. (B)(4). ANY BREATHING CIRCUIT WHICH FAILS ANY OF THESE TESTS IS DISCARDED. THIS SUGGESTS THAT THE BREATHING CIRCUIT WAS DAMAGED AFTER THE PRODUCT WAS RELEASED FOR DISTRIBUTION. (B)(4). 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; FIT ONLY THE SUPPLIED FISHER & PAYKEL HEALTHCARE CIRCUIT HANGER WITH CARE TO AVOID CIRCUIT DAMAGE.

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED THAT AN AIR LEAK OCCURRED AS THE EXPIRATORY LIMB OF AN RT340 ADULT BREATHING CIRCUIT WAS FOUND TO BE FAULTY. NO PATIENT CONSEQUENCE WAS REPORTED.

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED THAT AN AIR LEAK OCCURRED AS THE EXPIRATORY LIMB OF AN RT340 ADULT BREATHING CIRCUIT WAS FOUND TO BE FAULTY. NO PATIENT CONSEQUENCE WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    202989 ADULT DUAL-HEATED WITH EVAQUA BREATHING CIRCUIT BZE BZE FISHER & PAYKEL HEALTHCARE LTD RT340

    Patients

    Seq Age Sex Outcome Treatment
    1