BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BI-LEVEL/CPAP INSPIRATORY HEATED CIRCUIT

    MDR report key: 3982384 · Received August 6, 2014

    Report

    Report Number
    9611451-2014-00679
    Event Type
    Malfunction
    Date Received
    August 6, 2014
    Date of Event
    June 30, 2014
    Report Date
    July 7, 2014
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LTD
    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 RT319 ADULT 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 RT319 ADULT BREATHING CIRCUIT WAS RETURNED TO FISHER & PAYKEL HEALTHCARE WHERE IT WAS VISUALLY INSPECTED. RESULTS: VISUAL INSPECTION REVEALED A HOLE APPROXIMATELY 10CM FROM THE PROXIMAL CONNECTOR. A LOT CHECK REVEALED NO OTHER COMPLAINTS OF THIS NATURE FOR LOT 140306. CONCLUSION: WE ARE UNABLE TO DETERMINE THE CAUSE OF THE HOLE ON THE RETURNED BREATHING CIRCUIT. ALL BREATHING CIRCUITS ARE PRESSURE TESTED FOR LEAKS PRIOR TO BEING RELEASED FOR DISTRIBUTION. ANY CIRCUITS THAT FAIL ARE REJECTED. THIS SUGGESTS THE RETURNED RT319 ADULT BREATHING CIRCUIT WAS DAMAGED AFTER IT WAS RELEASED FOR DISTRIBUTION. THE USER INSTRUCTIONS ACCOMPANIED BY THE RT319 ADULT BREATHING CIRCUIT STATE: -"BEFORE CONNECTING TO PATIENT, ENSURE THAT FLOW AND PRESSURE TESTING APPLICABLE TO THE VENTILATOR HAS BEEN COMPLETED." -"SET APPROPRIATE VENTILATOR ALARMS." THE HOSPITAL STAFF CORRECTLY CHECKED THE BREATHING CIRCUIT PRIOR TO PATIENT USE. THIS IS IN LINE WITH OUR USER INSTRUCTIONS.

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED TO A FISHER & PAYKEL HEALTHCARE (FPH) REPRESENTATIVE THAT AN RT319 ADULT BREATHING CIRCUIT FAILED THE LEAK TEST ON A CARINA VENTILATOR PRIOR TO PATIENT USE. THEY FURTHER REPORTED A PIN HOLE IN THE CIRCUIT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    461466 BI-LEVEL/CPAP INSPIRATORY HEATED CIRCUIT BTT BTT FISHER & PAYKEL HEALTHCARE LTD RT319 140306

    Patients

    Seq Age Sex Outcome Treatment
    1 CARINA VENTILATOR