BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADULT INSPIRATORY HEATED BREATHING CIRCUIT

    MDR report key: 3100876 · Received May 8, 2013

    Report

    Report Number
    9611451-2013-00364
    Event Type
    Malfunction
    Date Received
    May 8, 2013
    Date of Event
    April 5, 2013
    Report Date
    April 11, 2013
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LTD
    Product Code
    BTT
    PMA / PMN Number
    SEE H10
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE RT206 ADULT INSPIRATORY-HEATED BREATHING CIRCUIT IS NOT SOLD IN THE USA BUT IT IS SIMILAR TO A PRODUCT WHICH IS SOLD IN THE USA. THE 510(K) FOR THAT PRODUCT IS K983112. METHOD: THE COMPLAINT RT206 ADULT BREATHING CIRCUIT WAS RETURNED TO FISHER & PAYKEL HEALTHCARE IN (B)(4) FOR EVALUATION. IT WAS VISUALLY INSPECTED AND PRESSURE TESTED TO IDENTIFY THE REPORTED LEAK. THE RETURNED BREATHING CIRCUIT WAS THEN SUBMERGED IN A WATER BATH TO LOCATE THE SOURCE OF THE LEAK. RESULTS: THE PRESSURE TEST REVEALED THAT THE RETURNED RT206 ADULT BREATHING CIRCUIT EXHIBITED LEAK AND WAS OUT OF SPECIFICATION. THE WATER BATH TEST REVEALED THAT THE SOURCE OF THE LEAK WAS THE CONNECTION BETWEEN THE LID AND BOWL OF THE WATER TRAP. A LOT CHECK WAS NOT PERFORMED AS NO LOT NUMBER WAS PROVIDED. CONCLUSION: THE WATER TRAP ON THE RT206 ADULT BREATHING CIRCUIT CONSISTS OF A BOWL AND LID, WHICH CAN BE SEPARATED TO ALLOW THE CAREGIVER TO EMPTY THE WATER TRAP. ALL BREATHING CIRCUITS ARE PRESSURE TESTED FOR LEAKS DURING PRODUCTION AND THOSE THAT FAIL ARE REJECTED. THIS SUGGESTS ANY LEAK MUST HAVE DEVELOPED AFTER THE RT206 ADULT BREATHING CIRCUIT WAS RELEASED FOR DISTRIBUTION POSSIBLY DURING TRANSPORT, STORAGE OR DISTORTION OF THE WATER TRAP WHEN THE BOWL WAS RECONNECTED. THE USER INSTRUCTIONS THAT ACCOMPANY THE RT206 BREATHING CIRCUIT STATE THE FOLLOWING: "CHECK ALL CONNECTIONS ARE TIGHT BEFORE USE." "PERFORM A PRESSURE AND LEAK TEST ON THE BREATHING SYSTEM AND CHECK FOR OCCLUSIONS BEFORE CONNECTING TO A PATIENT." "SET APPROPRIATE VENTILATOR ALARMS."

    Additional Manufacturer Narrative · 1

    (B)(4). THE RT206 ADULT INSPIRATORY-HEATED BREATHING CIRCUIT IS NOT SOLD IN THE USA BUT IT IS SIMILAR TO A PRODUCT WHICH IS SOLD IN THE USA. THE 510(K) FOR THAT PRODUCT IS K983112. THE COMPLAINT RT206 BREATHING CIRCUIT IS CURRENTLY IN TRANSIT TO FISHER & PAYKEL HEALTHCARE (B)(4) FOR EVALUATION. WE WILL PROVIDE A FOLLOW UP REPORT UPON RECEIPT OF THE COMPLAINT DEVICE AND COMPLETION OF OUR INVESTIGATION.

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED VIA A DISTRIBUTOR THAT AN AIR LEAK THAT WAS CAUSED BY THE EXPIRATORY LIMB OF AN RT206 ADULT INSPIRATORY-HEATED BREATHING CIRCUIT. NO PATIENT CONSEQUENCE WAS REPORTED.

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED VIA A DISTRIBUTOR THAT AN AIR LEAK THAT WAS CAUSED BY THE EXPIRATORY LIMB OF AN RT206 ADULT INSPIRATORY-HEATED BREATHING CIRCUIT. NO PATIENT CONSEQUENCE WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    201538 ADULT INSPIRATORY HEATED BREATHING CIRCUIT BTT BTT FISHER & PAYKEL HEALTHCARE LTD RT206

    Patients

    Seq Age Sex Outcome Treatment
    1