BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADULT INSPIRATORY HEATED BREATHING CIRCUIT

    MDR report key: 3380196 · Received October 1, 2013

    Report

    Report Number
    9611451-2013-00751
    Event Type
    Malfunction
    Date Received
    October 1, 2013
    Date of Event
    September 5, 2013
    Report Date
    September 5, 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 RT105 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 BREATHING CIRCUIT WAS RETURNED TO FISHER & PAYKEL HEALTHCARE (B)(4) FOR EVALUATION. THE COMPLAINT CIRCUIT WAS PRESSURE TESTED TO OUR PRODUCT SPECIFICATION AND SUBMERGED IN A WATER BATH TO TEST FOR LEAKS. RESULTS: THE PRESSURE TEST IDENTIFIED A LEAK AND THE WATER BATH TEST IDENTIFIED THE LEAK TO BE AT THE CONNECTION BETWEEN THE LID AND BOWL OF THE WATER TRAP, CONFIRMING THE REPORTED FAULT. A LOT CHECK REVEALED ONE OTHER COMPLAINT FOR LOT NUMBER 130515. CONCLUSION: THE RT105 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 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 BREATHING CIRCUITS WERE RELEASED FOR DISTRIBUTION, DURING TRANSPORT, STORAGE OR USE, POSSIBLY BY DISTORTION OF THE WATER TRAP WHEN THE BOWL WAS CONNECTED. OUR USER INSTRUCTIONS THAT ACCOMPANY THE RT105 ADULT 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." THE HOSPITAL CORRECTLY FOLLOWED OUR USER INSTRUCTIONS AND DETECTED THE LEAKS DURING A SETUP CHECK BEFORE USE ON A PATIENT.

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED TO A FISHER & PAYKEL HEALTHCARE FIELD REPRESENTATIVE THAT AN RT105 ADULT BREATHING CIRCUIT FAILED THE LEAK TEST ON THE SERVO-I VENTILATOR. THIS WAS FOUND PRIOR TO PATIENT USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    494559 ADULT INSPIRATORY HEATED BREATHING CIRCUIT BTT BTT FISHER & PAYKEL HEALTHCARE LIMITED RT105 130515

    Patients

    Seq Age Sex Outcome Treatment
    1 SERVO-I VENTILATOR