BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADULT INSPIRATORY HEATED BREATHING CIRCUIT

    MDR report key: 3366183 · Received September 24, 2013

    Report

    Report Number
    9611451-2013-00718
    Event Type
    Malfunction
    Date Received
    September 24, 2013
    Date of Event
    August 23, 2013
    Report Date
    August 26, 2013
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LIMITED
    Product Code
    BTT
    PMA / PMN Number
    SEE H10
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE RT212 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 RT212 BREATHING CIRCUIT WAS RETURNED TO FISHER & PAYKEL HEALTHCARE IN (B)(4) FOR EVALUATION. IT WAS PRESSURE TESTED FOR LEAKS AND WAS SUBSEQUENTLY SUBMERGED IN A WATER BATH TO IDENTIFY THE SOURCE OF THE LEAK. RESULTS: THE PRESSURE TEST REVEALED THAT THE RT212 BREATHING CIRCUIT WAS OUT OF SPECIFICATION. A WATER BATH TEST IDENTIFIED THE SOURCE OF THE LEAK TO BE BETWEEN THE WATER TRAP LID AND BOWL. A LOT CHECK REVEALED NO OTHER COMPLAINT OF THIS NATURE FOR LOT 130412. CONCLUSION: THE BREATHING CIRCUIT WATER TRAP CONSISTS OF A BOWL AND A 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 THAT ANY LEAK MUST HAVE DEVELOPED AFTER THE CIRCUIT WAS RELEASED FOR DISTRIBUTION MOST LIKELY DURING TRANSPORT, STORAGE OR USE, POSSIBLY BY DISTORTION OF THE WATER TRAP WHEN THE BOWL WAS CONNECTED. THE HOSPITAL CORRECTLY FOLLOWED OUR USER INSTRUCTIONS AND DETECTED THE MALFUNCTION DURING A SETUP CHECK BEFORE USE ON A PATIENT. OUR USER INSTRUCTIONS THAT ACCOMPANY THE RT212 ADULT INSPIRATORY HEATED 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."

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED TO A FISHER & PAYKEL HEALTHCARE REPRESENTATIVE THAT AN RT212 ADULT BREATHING CIRCUIT FAILED THE LEAK TEST ON A VENTILATOR PRIOR TO PATIENT USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    481807 ADULT INSPIRATORY HEATED BREATHING CIRCUIT BTT BTT FISHER & PAYKEL HEALTHCARE LIMITED RT212 130412

    Patients

    Seq Age Sex Outcome Treatment
    1 ZAVINA VENTILATOR