BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADULT DUAL-HEATED EVAQUA BREATHING CIRCUIT

    MDR report key: 1315569 · Received February 13, 2009

    Report

    Report Number
    9611451-2009-00081
    Event Type
    Malfunction
    Date Received
    February 13, 2009
    Report Date
    January 14, 2009
    Manufacturer
    FISHER & PAYKEL HEALTHCARE, LTD.
    Product Code
    BZE
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    PS42775. THIS IS A MALFUNCTION THAT HAS BEEN REPORTED TO FISHER & PAYKEL HEALTHCARE ('FPH') BY A HEALTHCARE FACILITY IN (B) (6). THE PRODUCT 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. FPH UNDERSTANDS THE SUBJECT RT340 EVAQUA BREATHING CIRCUIT WILL NOT BE RETURNED FOR EXAMINATION. IN ORDER TO ASSIST IN OUR ANALYSIS OF THE EVENT, FPH HAS REQUESTED ADDITIONAL INFO PERTAINING TO THE EQUIPMENT SET-UP, SETTINGS AND TYPE OF DRUGS USED IN THE THERAPY. THE KEY DIFFERENCE BETWEEN FPH'S EVAQUA BREATHING CIRCUITS AND THE CONVENTIONAL BREATHING CIRCUITS IS THAT THE EXPIRATORY TUBE OF EVAQUA CIRCUITS SUCH AS THE RT340 IS COMPOSED OF A THIN, SEMI-PERMEABLE FILM SPECIALLY DESIGNED TO ALLOW WATER VAPOR FROM EXPIRED VENTILATORY GASES TO PASS THROUGH. THIS IMPROVED TECHNOLOGY WAS DEVELOPED TO OVERCOME CONDENSATE-RELATED ISSUES ASSOCIATED WITH CONVENTIONAL BREATHING CIRCUITS. THE EXPIRATORY TUBE OF AN EVAQUA BREATHING CIRCUIT INCORPORATES A PROTECTIVE MESH TO PREVENT DAMAGE TO THE WALLS OF THE TUBE DURING USE. NONETHELESS, THE EVAQUA TUBING REMAINS MORE SUSCEPTIBLE TO DAMAGE THAN CONVENTIONAL CIRCUITS WHEN EXPOSED TO ROUGH HANDLING OR TO DAMAGE CAUSED BY SHARP OBJECTS AND CIRCUIT HANGERS. OUR INSTRUCTIONS FOR USE SPECIFY TO THE USER TO "FIT ONLY THE SUPPLIED FISHER & PAYKEL HEALTHCARE CIRCUIT HANGER WITH CARE TO AVOID CIRCUIT DAMAGE." A LOT CHECK COULD NOT BE PERFORMED AS NO SPECIFIC LOT INFO WAS PROVIDED. WE WILL PROVIDE A F/U REPORT UPON RECEIPT OF THE INFO REQUESTED AND FOLLOWING COMPLETION OF THE ANALYSIS.

    Description of Event or Problem · 1

    A HEALTHCARE FACILITY IN (B) (6) REPORTED VIA A FISHER & PAYKEL HEALTHCARE REP THAT IN (B) (6) 2009, A VENTILATOR CONNECTED TO AN RT340 ADULT DUAL-HEATED EVAQUA BREATHING CIRCUIT ALARMED THAT A LEAK HAD OCCURRED WHILST THE SET-UP WAS IN USE ON A PT. THE SYSTEM HAD PASSED THE VENTILATOR LEAK TEST DURING EQUIPMENT SET-UP. WHEN THE VENTILATOR ALARMED, THE EXPIRATORY LIMB OF THE RT340 BREATHING CIRCUIT WAS FOUND TO CONTAIN A NUMBER OF SMALL HOLES. THE PT'S CONDITION WAS REPORTED AS SATISFACTORY.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1