BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OPTIFLOW NASAL CANNULA

    MDR report key: 2962765 · Received February 14, 2013

    Report

    Report Number
    9611451-2013-00097
    Event Type
    Malfunction
    Date Received
    February 14, 2013
    Date of Event
    January 16, 2013
    Report Date
    January 18, 2013
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LTD
    Product Code
    CAT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). METHOD: THE COMPLAINT OPT544 WAS RETURNED TO THE MANUFACTURER AND VISUALLY INSPECTED. RESULTS: THE VISUAL INSPECTION REVEALED THAT THE 220M LONG TUBE WAS SEPARATED FROM THE MANIFOLD, CONFIRMING THE REPORTED FAULT. A LOT CHECK COULD NOT BE PERFORMED AS NO LOT NUMBER WAS PROVIDED. CONCLUSION: WE ARE UNABLE TO DETERMINE WHAT MAY HAVE CAUSED THE PROBLEM. HOWEVER, THE CUSTOMER HAS REPORTED THAT THE TUBING SEPARATED FROM THE MANIFOLD 6 DAYS AFTER USE AND THIS SUGGESTS THAT THE DAMAGE OCCURRED POST PRODUCTION. 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. THE OPT544 INTERFACE IS SHIPPED TO THE CUSTOMER FULLY ASSEMBLED. THE CANNULA IS 100% INSPECTED BY PRODUCTION LINE STAFF DURING ASSEMBLY FOR VISUAL DEFECTS SUCH AS CRACKS, TEARS, INCLUSIONS, DISCOLOURATION AND DEFORMATION. IF ANY ARE FOUND THE PRODUCT IS DISCARDED.

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED THAT THE TUBE OF AN OPT544 NASAL CANNULA CAME APART FROM THE CANNULA MANIFOLD SIX DAYS AFTER USE. NO PATIENT CONSEQUENCE WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    64441 OPTIFLOW NASAL CANNULA CAT CAT FISHER & PAYKEL HEALTHCARE LTD OPT544 NP

    Patients

    Seq Age Sex Outcome Treatment
    1