BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADULT DUAL-HEATED EVAQUA BREATHING CIRCUIT

    MDR report key: 2083628 · Received May 10, 2011

    Report

    Report Number
    9611451-2011-00288
    Event Type
    Malfunction
    Date Received
    May 10, 2011
    Date of Event
    April 14, 2011
    Report Date
    April 14, 2011
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LIMITED
    Product Code
    BZE
    PMA / PMN Number
    REFER TO H10
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EI
    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. LOT NUMBERS, DEVICE MANUFACTURE DATES: QUANTITY: 1, LOT NUMBER: 100625, DEVICE MFR DATE: 06/25/2010. QUANTITY: 1, LOT NUMBER: 101014, MFR DATE: 10/14/2010. QUANTITY: 1, LOT NUMBER: 101122, MFR DATE: 11/22/2010. QUANTITY: 1, LOT NUMBER: NOT PROVIDED, MFR DATE: UNKNOWN. THE COMPLAINT BREATHING CIRCUITS HAVE ONLY RECENTLY BEEN RETURNED TO FISHER & PAYKEL HEALTHCARE AND ARE CURRENTLY BEING INVESTIGATED. WE WILL PROVIDE A FOLLOW-UP REPORT ONCE WE HAVE COMPLETED 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 (B)(4). QUANTITY: 1, LOT NUMBER: 100625, DEVICE MANUFACTURE DATE: 06/25/2010; 1, 101014, 10/14/2010; 1, 101122, 11/22/2010; 1, NOT PROVIDED, UNKNOWN. METHOD: THE FOUR RT340 ADULT DUAL-HEATED EVAQUA BREATHING CIRCUITS WERE RETURNED TO FPH (B)(4) FOR INSPECTION. THE RETURNED BREATHING CIRCUITS WERE VISUALLY INSPECTED FOR DAMAGE AND PRESSURE TESTED FOR LEAKS. RESULTS: NO PHYSICAL DAMAGE WAS NOTED WITH THE RETURNED BREATHING CIRCUITS. THE PRESSURE TEST RESULTS WERE WITHIN THE REQUIRED SPECIFICATION. CONCLUSION: ALL CIRCUITS ARE PRESSURE TESTED BEFORE THEY ARE ALLOWED TO LEAVE THE PRODUCTION LINE. (B)(4). NO FAULT WAS FOUND WITH THE RETURNED RT340 ADULT BREATHING CIRCUITS AS IT PASSED BOTH VISUAL INSPECTION AND PRESSURE TEST. THE KEY DIFFERENCE BETWEEN FPH'S EVAQUA BREATHING CIRCUITS AND CONVENTIONAL BREATHING CIRCUITS IS THAT THE EXPIRATORY TUBE OF EVAQUA CIRCUITS SUCH AS THE RT340 IS COMPOSED OF A (B)(4) SPECIALLY DESIGNED TO ALLOW WATER VAPOUR FROM EXPIRED VENTILATORY GASES TO PASS THROUGH. THE EVAQUA EXPIRATORY TUBE HAS A PROTECTIVE MESH WHICH PREVENTS DAMAGE TO THE WALLS OF THE TUBE, HOWEVER THE EVAQUA TUBING REMAINS MORE SUSCEPTIBLE TO DAMAGE THAN CONVENTIONAL CIRCUITS WHEN EXPOSED TO ROUGH HANDLING OR DAMAGE CAUSED BY SHARP OBJECTS AND CIRCUIT HANGERS. THE USER INSTRUCTIONS SUPPLIED WITH THE RT340 BREATHING CIRCUIT STATE THE FOLLOWING: "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 TO A FISHER & PAYKEL HEALTHCARE (FPH) FIELD REPRESENTATIVE THAT FOUR RT340 ADULT DUAL-HEATED EVAQUA BREATHING CIRCUITS OF DIFFERENT LOT NUMBERS WERE FOUND LEAKING PRIOR TO PATIENT USE. NO PATIENT CONSEQUENCE WAS REPORTED.

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED TO A FISHER & PAYKEL HEALTHCARE (FPH) FIELD REPRESENTATIVE THAT FOUR RT340 ADULT DUAL-HEATED EVAQUA BREATHING CIRCUITS OF DIFFERENT LOT NUMBERS WERE FOUND LEAKING PRIOR TO PATIENT USE. NO PATIENT CONSEQUENCE WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ADULT DUAL-HEATED EVAQUA BREATHING CIRCUIT BZE BZE FISHER & PAYKEL HEALTHCARE LIMITED RT340 REFER TO H10

    Patients

    Seq Age Sex Outcome Treatment
    1