BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OPTIFLOW NASAL CANNULA

    MDR report key: 4237970 · Received November 7, 2014

    Report

    Report Number
    9611451-2014-00852
    Event Type
    Malfunction
    Date Received
    November 7, 2014
    Date of Event
    September 29, 2014
    Report Date
    October 9, 2014
    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). METHOD: ONLY ONE OPT546 ADULT NASAL CANNULA WAS RETURNED TO FISHER & PAYKEL HEALTHCARE IN (B)(4) WHERE IT WAS VISUALLY INSPECTED. RESULTS: VISUAL INSPECTION REVEALED THAT ONLY THE TUBING OF THE OPT546 WAS RETURNED. THE TUBING CONNECTS TO THE MANIFOLD AND PRONGS WHICH WERE NOT RETURNED. THE TUBING WAS DISCONNECTED FROM THE MANIFOLD. THE HOSPITAL FURTHER REPORTED THAT THE TUBING MAY HAVE BEEN PUT UNDER SOME TENSION. A LOT CHECK REVEALED NO OTHER COMPLAINTS OF THIS NATURE FOR LOT 121128. 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 (MANIFOLD) 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 OPT546 WAS MOST LIKELY CAUSED BY PULLING ON THE TUBE BY THE PATIENT OR HOSPITAL STAFF. ALL CANNULAS ARE VISUALLY INSPECTED FOR CRACKS, TEARS, INCLUSIONS, DISCOLOURATION AND DEFORMATION PRIOR TO LEAVING PRODUCTION AND THOSE THAT FAIL ARE REJECTED. OUR USER INSTRUCTIONS THAT ACCOMPANY THE OPT546 ILLUSTRATE THE PROCEDURE FOR FITTING THE OPTIFLOW NASAL CANNULA TO A PATIENT AND STATE THE FOLLOWING: -"DO NOT CRUSH OR STRETCH TUBE."

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED TO A FISHER & PAYKEL HEALTHCARE (FPH) REPRESENTATIVE THAT THREE OPT546 ADULT OPTIFLOW CANNULAS WERE DAMAGED. NO PATIENT CONSEQUENCE WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    720541 OPTIFLOW NASAL CANNULA CAT CAT FISHER & PAYKEL HEALTHCARE LTD OPT546 121128

    Patients

    Seq Age Sex Outcome Treatment
    1