BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADULT INSPIRATORY HEATED BREATHING CIRCUIT

    MDR report key: 3312221 · Received August 27, 2013

    Report

    Report Number
    9611451-2013-00640
    Event Type
    Malfunction
    Date Received
    August 27, 2013
    Date of Event
    July 29, 2013
    Report Date
    August 1, 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 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: WE RECEIVED TWO COMPLAINT DEVICES FOR EVALUATION: ONE FROM LOT 130424 AND ONE WITH NO LOT NUMBER INFORMATION PROVIDED. THE BREATHING CIRCUITS WERE PRESSURE TESTED TO OUR PRODUCT SPECIFICATION TO CHECK FOR ANY LEAKS AND SUBMERGED IN A WATER BATH TO CHECK FOR THE SOURCE OF THE LEAK. RESULTS: THE PRESSURE TEST REVEALED THAT BOTH CIRCUITS WERE OUT OF SPECIFICATION. THE WATER BATH TEST SHOWED THAT THE LEAK WAS AT THE CONNECTION BETWEEN THE LID AND THE BOWL OF THE WATER TRAP FOR BOTH CIRCUITS. A LOT CHECK REVEALED NO OTHER COMPLAINTS OF THIS NATURE FOR LOT 130424. CONCLUSION: THE RT206 BREATHING CIRCUIT WATER TRAP CONSISTS OF A BOWL AND A LID. THE WATER TRAP BOWL AND LID CAN BE SEPARATED TO ALLOW THE CAREGIVER TO EMPTY THE WATER TRAP. ALL CIRCUITS ARE PRESSURE TESTED FOR LEAKS DURING PRODUCTION AND THOSE THAT FAIL ARE REJECTED. THIS SUGGESTS ANY LEAK MUST HAVE DEVELOPED AFTER IT WAS RELEASED FOR DISTRIBUTION, DURING TRANSPORT, STORAGE OR USE, POSSIBLY BY DISTORTION OF THE WATER TRAP WHEN THE BOWL WAS CONNECTED. THE USER INSTRUCTIONS FOR RT206 ADULT BREATHING CIRCUIT STATE THE FOLLOWING: CHECK ALL CONNECTIONS ARE TIGHT BEFORE USE - SET APPROPRIATE VENTILATOR ALARMS.

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6), REPORTED VIA OUR DISTRIBUTOR THAT TWO RT206 ADULT BREATHING CIRCUITS FAILED THE VENTILATOR LEAK TEST ON A PB840 VENTILATOR. THIS WAS FOUND PRIOR TO PATIENT USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    418692 ADULT INSPIRATORY HEATED BREATHING CIRCUIT BTT BTT FISHER & PAYKEL HEALTHCARE LTD RT206 130424

    Patients

    Seq Age Sex Outcome Treatment
    1 PB840 VENTILATOR