BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OPTIFLOW NASAL CANNULA

    MDR report key: 2834571 · Received November 15, 2012

    Report

    Report Number
    9611451-2012-00819
    Event Type
    Malfunction
    Date Received
    November 15, 2012
    Report Date
    October 17, 2012
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LTD
    Product Code
    CAT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). METHOD: THE COMPLAINT OPT546 OPTIFLOW NASAL CANNULA WAS RETURNED TO FISHER & PAYKEL HEALTHCARE IN (B)(4) AND WAS VISUALLY INSPECTED FOR THE REPORTED DAMAGE. RESULTS: VISUAL INSPECTION REVEALED THAT THE TUBING WAS STRETCHED AND THE BREATHABLE FILM WAS TORN. A LOT CHECK REVEALED ONE OTHER COMPLAINT OF THIS NATURE FOR LOT NUMBER 120326. CONCLUSION: THE OPT546 OPTIFLOW NASAL CANNULA IS USED TO DELIVER HUMIDIFIED OXYGEN TO PATIENTS. IT 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 DAMAGE OBSERVED TO THE RETURNED OPTIFLOW NASAL CANNULA WAS MOST LIKELY CAUSED BY PULLING ON THE TUBE BY THE PATIENT OR HOSPITAL STAFF. THE OPT546 INTERFACE IS SHIPPED TO THE CUSTOMER FULLY ASSEMBLED WITH THE NASAL PRONGS FIRMLY SEATED ON THE PLASTIC MANIFOLD. THE INTERFACE 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 INTERFACE IS REJECTED.

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) HAS REPORTED THAT AN OPT546 OPTIFLOW CANNULA BECAME DAMAGED DURING USE ON A PATIENT. NO PATIENT CONSEQUENCE WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OPTIFLOW NASAL CANNULA CAT CAT FISHER & PAYKEL HEALTHCARE LTD OPT546 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1