BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADULT DUAL HEATED EVAQUA BREATHING CIRCUIT

    MDR report key: 2230295 · Received September 1, 2011

    Report

    Report Number
    9611451-2011-00534
    Event Type
    Malfunction
    Date Received
    September 1, 2011
    Report Date
    August 5, 2011
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LTD
    Product Code
    BZE
    PMA / PMN Number
    SEE H10
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    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. METHOD: THE RETURNED COMPLAINT EVAQUA EXPIRATORY LIMB OF THE BREATHING CIRCUIT WAS VISUALLY INSPECTED AND PRESSURE TESTED. RESULTS: THE VISUAL INSPECTION REVEALED A HOLE APPROXIMATELY 30 CM AWAY FROM THE PATIENT END CONNECTOR. THE HOLE HAD THE APPEARANCE OF HAVING BEEN PUNCTURED OR SCRATCHED WITH A BLUNT OBJECT. THE PRESSURE TEST REVEALED EXCESSIVE LEAK, DUE TO THE OBSERVED DAMAGE. A LOT CHECK REVEALED NO OTHER COMPLAINTS OF THIS NATURE FOR THE LOT NUMBER PROVIDED. CONCLUSION: BASED ON INSPECTION OF THE HOLE, THE COMPLAINT EVAQUA EXPIRATORY LIMB OF THE BREATHING CIRCUIT WAS PUNCTURED OR SCRATCHED BY A BLUNT OBJECT. ALL BREATHING CIRCUITS ARE PRESSURE TESTED FOR LEAKS PRIOR TO DISTRIBUTION. ANY BREATHING CIRCUIT WHICH DOES NOT PASS THE PRESSURE TEST IS DISCARDED. THIS SUGGESTS THAT THE BREATHING CIRCUIT WAS PUNCTURED POST-PRODUCTION, POSSIBLY DURING STORAGE OR SETUP. (B)(4). OUR USER INSTRUCTIONS ADVISE THE USER TO "FIT ONLY SUPPLIED FISHER & PAYKEL HEALTHCARE CIRCUIT HANGER WITH CARE TO AVOID CIRCUIT DAMAGE." THE RT340 USER INSTRUCTIONS INCLUDE THE FOLLOWING STATEMENT: "SET APPROPRIATE VENTILATOR ALARMS", AS VENTILATOR ALARMS ALERT THE USER TO A LEAK IN THE SYSTEM AND ALLOWS CAREGIVERS TO ACT BY REPLACING THE BREATHING CIRCUIT ACCORDING TO THEIR STANDARD PROCEDURES. IT ALSO ADVISE THE USER TO "FIT ONLY THE SUPPLIED FISHER & PAYKEL HEALTHCARE CIRCUIT HANGER WITH CARE TO AVOID CIRCUIT DAMAGE". (B)(4).

    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 BREATHING CIRCUIT IS EN ROUTE TO FISHER & PAYKEL HEALTHCARE (B)(4) FOR EVALUATION. WE WILL PROVIDE A FOLLOW UP REPORT UPON RECEIPT OF THE DEVICE AND COMPLETION OF OUR INVESTIGATION.

    Description of Event or Problem · 1

    A DISTRIBUTOR IN (B)(6) REPORTED THAT AN RT340 ADULT BREATHING CIRCUIT WAS LEAKING. THIS WAS FOUND DURING AN INWARDS GOODS INSPECTION.

    Description of Event or Problem · 1

    A DISTRIBUTOR IN (B)(4) REPORTED THAT AN RT340 ADULT BREATHING CIRCUIT WAS LEAKING. THIS WAS FOUND DURING AN INWARDS GOODS INSPECTION.

    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 100622

    Patients

    Seq Age Sex Outcome Treatment
    1