BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADULT NASAL INTERFACE

    MDR report key: 1802104 · Received August 17, 2010

    Report

    Report Number
    9611451-2010-00491
    Event Type
    Malfunction
    Date Received
    August 17, 2010
    Date of Event
    July 22, 2010
    Report Date
    July 23, 2010
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LTD
    Product Code
    CAT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE OPT544 INTERFACE IS USED TO DELIVER HUMIDIFIED OXYGEN TO PATIENTS. THE OPT544 CONSISTS OF A LIGHTWEIGHT DELIVERY TUBE WHICH IS CONNECTED TO A RIGID PLASTIC BASE AND SOFT NASAL PRONGS (NASAL INTERFACE). THE INTERFACE IS HELD IN PLACE BY A HEAD STRAP AND ALSO INCLUDES A LANYARD WHICH IS PLACED AROUND THE PATIENT'S NECK OR ATTACHED TO THE PATIENT'S CLOTHING OR BEDDING TO REMOVE THE LOAD OF THE BREATHING CIRCUIT FROM THE PATIENT'S NARES. METHOD: ONE COMPLAINT DEVICE WAS RETURNED AND WAS VISUALLY INSPECTED, USING A MAGNIFYING LAMP TO CHECK FOR HOLES. RESULTS: THE COMPLAINT DEVICE WAS RECEIVED WITH THE EVAQUA TUBING DETACHED FROM THE MANIFOLD. THERE WERE NO HOLES OR ANY OTHER KIND OF DAMAGE TO THE FLEXI TUBING. NO DAMAGE WAS NOTED TO THE OTHER PARTS OF THE DEVICE. A LOT CHECK REVEALED NO OTHER COMPLAINTS FOR THE LOT NUMBER PROVIDED. CONCLUSION: WE ARE UNABLE TO DETERMINE THE ROOT CAUSE OF THE SEPARATION. THE OPT544 INTERFACE IS SHIPPED TO THE CUSTOMER FULLY ASSEMBLED WITH THE NASAL PRONGS FIRMLY SEATED ON THE PLASTIC MANIFOLD. WE ARE ALSO UNABLE TO REACH ANY CONCLUSION REGARDING HOLES IN THE TUBING AS THE RETURNED DEVICE WAS FREE OF HOLES OR ANY OTHER DAMAGE.

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED THAT THREE OPT544 ADULT NASAL INTERFACES WERE COMING APART AT THE NASAL CONNECTION AND THAT THERE WERE HOLES IN THE TUBING. THIS WAS FOUND BEFORE USE ON A PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ADULT NASAL INTERFACE CAT CAT FISHER & PAYKEL HEALTHCARE LTD OPT544 100426

    Patients

    Seq Age Sex Outcome Treatment
    1