BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BI-LEVEL/CPAP INSPIRATORY HEATED CIRCUIT

    MDR report key: 5626569 · Received May 3, 2016

    Report

    Report Number
    9611451-2016-00195
    Event Type
    Malfunction
    Date Received
    May 3, 2016
    Date of Event
    March 23, 2016
    Report Date
    April 8, 2016
    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 (B)(4) WHERE IT WAS VISUALLY INSPECTED. RESULTS: VISUAL INSPECTION REVEALED A CUT IN THE COMPLAINT CIRCUIT. A LOT CHECK REVEALED NO OTHER COMPLAINTS OF THIS NATURE FOR LOT 150611. CONCLUSION: BASED ON THE DAMAGE OBSERVED ON THE RETURNED RT319 ADULT BREATHING CIRCUIT, IT IS LIKELY THAT THE CIRCUIT WAS CUT WITH A SHARP OBJECT. ALL BREATHING CIRCUITS ARE PRESSURE TESTED FOR LEAKS PRIOR TO BEING RELEASED FOR DISTRIBUTION. ANY CIRCUITS THAT FAIL ARE REJECTED. THE HOSPITAL REPORTED THAT THE REPORTED DAMAGE OCCURRED AFTER ONE DAY OF USE, WHICH SUGGESTS THAT 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.

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED VIA A DISTRIBUTOR THAT AN RT319 ADULT BREATHING CIRCUIT STARTED TO LEAK AFTER ONE DAY OF USE. THEY FURTHER REPORTED A PIN HOLE ON THE CIRCUIT. NO PATIENT CONSEQUENCE WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    282776 BI-LEVEL/CPAP INSPIRATORY HEATED CIRCUIT BTT BTT FISHER & PAYKEL HEALTHCARE LTD RT319 150611

    Patients

    Seq Age Sex Outcome Treatment
    1