BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADULT BREATHING CIRCUIT

    MDR report key: 2001253 · Received February 24, 2011

    Report

    Report Number
    9611451-2011-00094
    Event Type
    Malfunction
    Date Received
    February 24, 2011
    Date of Event
    January 27, 2011
    Report Date
    January 31, 2011
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LIMITED
    Product Code
    BTT
    PMA / PMN Number
    K033710
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). (B)(6). METHOD: THE RETURNED BREATHING CIRCUIT WAS PRESSURE TESTED AND SUBMERGED IN A WATER BATH TO TEST FOR LEAKS. RESULTS: A LEAK WAS FOUND IN THE INSPIRATORY AND EXPIRATORY WATER TRAPS. THE WATER TRAP OF THE BREATHING CIRCUIT CONSISTS OF TWO PARTS WHERE THE LOWER PART CAN BE REMOVED DURING USE FOR DRAINING WATER. THE WATER TRAP LEAKS WERE LOCATED AT THE SEAL BETWEEN THE WATER TRAP BOWL AND THE WATER TRAP LID. A LOT CHECK REVEALED NO OTHER SIMILAR COMPLAINTS FOR LOT NUMBER 100629. CONCLUSION: ALL BREATHING CIRCUITS ARE PRESSURE TESTED FOR LEAKS DURING PRODUCTION AND THOSE THAT FAIL ARE REJECTED. THIS SUGGESTS ANY LEAK MUST HAVE DEVELOPED POST PRODUCTION DURING TRANSPORT, STORAGE OR SETUP. OUR MONITORING AND TRENDING OF EVENTS INVOLVING WATER TRAP LEAKS IN ADULT BREATHING CIRCUITS HAS A RATE OF OCCURRENCE OF (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). THE COMPLAINT DEVICE HAS NOT YET BEEN RECEIVED BY FISHER & PAYKEL HEALTHCARE ((B)(4)) FOR INVESTIGATION. WE WILL PROVIDE A FOLLOW-UP REPORT UPON RECEIPT OF THE DEVICE AND COMPLETION OF OUR INVESTIGATION.

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED VIA A DISTRIBUTOR THAT THERE WAS AN AIR LEAK FROM THE WATER TRAP OF AN RT134 ADULT BREATHING CIRCUIT.THE LEAK WAS OBSERVED DURING SETUP OF THE DEVICE.

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED VIA A DISTRIBUTOR THAT THERE WAS AN AIR LEAK FROM THE WATER TRAP OF AN RT134 ADULT BREATHING CIRCUIT. THE LEAK WAS OBSERVED DURING SETUP OF THE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ADULT BREATHING CIRCUIT BTT BTT FISHER & PAYKEL HEALTHCARE LIMITED RT134 100629

    Patients

    Seq Age Sex Outcome Treatment
    1