BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BI-LEVEL/CPAP INSPIRATORY HEATED CIRCUIT

    MDR report key: 4399887 · Received January 8, 2015

    Report

    Report Number
    9611451-2015-00006
    Event Type
    Malfunction
    Date Received
    January 8, 2015
    Date of Event
    December 8, 2014
    Report Date
    December 10, 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 DAMAGE IN THE FORM OF CLAMP MARKS ON THE INSPIRATORY LIMB NEAR THE DISTAL CONNECTOR. A LOT CHECK REVEALED NO OTHER COMPLAINTS OF THIS NATURE FOR LOT 140709. CONCLUSION: WE ARE UNABLE TO DETERMINE WHAT MAY HAVE CAUSED THE DAMAGE OBSERVED ON THE RETURNED BREATHING CIRCUIT. THE HOSPITAL REPORTED THAT THE CIRCUIT WAS DAMAGED AFTER FOUR DAYS OF USE. THIS SUGGESTS THAT THE SUBJECT BREATHING CIRCUIT WAS DAMAGED AFTER IT WAS RELEASED FOR DISTRIBUTION. THE USER INSTRUCTIONS ACCOMPANIED BY THE RT319 ADULT BREATHING CIRCUIT STATE: -"DO NOT CRUSH TUBE." -"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 TO A FISHER & PAYKEL HEALTHCARE (FPH) REPRESENTATIVE THAT THE INSPIRATORY LIMB OF AN RT319 ADULT BREATHING CIRCUIT WAS DAMAGED AFTER FOUR DAYS OF USE. NO PATIENT CONSEQUECE WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    16100 BI-LEVEL/CPAP INSPIRATORY HEATED CIRCUIT BTT BTT FISHER & PAYKEL HEALTHCARE LTD RT319 140709

    Patients

    Seq Age Sex Outcome Treatment
    1