BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OPTIFLOW NASAL CANNULA

    MDR report key: 4708663 · Received April 20, 2015

    Report

    Report Number
    9611451-2015-00208
    Event Type
    Malfunction
    Date Received
    April 20, 2015
    Report Date
    March 23, 2015
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LIMITED
    Product Code
    CAT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE COMPLAINT OPT842 OPTIFLOW NASAL CANNULAS ARE EN ROUTE TO FISHER & PAYKEL HEALTHCARE IN (B)(4) FOR INVESTIGATION. WE WILL PROVIDE A FOLLOW-UP REPORT ONCE WE HAVE COMPLETED OUR INVESTIGATION.

    Additional Manufacturer Narrative · 1

    (B)(4). MANUFACTURER NARRATIVE: METHOD: TEN OPT542 OPTIFLOW NASAL CANNULAS WERE RETURNED TO FISHER & PAYKEL HEALTHCARE IN (B)(4). NINE OF THE 10 RETURNED DEVICES WERE STILL IN SEALED PLASTIC BAGS. ALL RETURNED DEVICES WERE VISUALLY INSPECTED. RESULTS: NO PHYSICAL DAMAGE WAS OBSERVED TO THE OPT542 CANNULAS IN THE SEALED PLASTIC BAGS. HOWEVER, VISUAL INSPECTION OF THE CANNULA IN AN UNSEALED PLASTIC BAG REVEALED THAT THE NASAL PRONG WAS BROKEN AT THE LEFT SIDE OF THE HEADGEAR CONNECTION POINT. A LOT CHECK REVEALED NO OTHER COMPLAINTS OF THIS NATURE FOR LOT NUMBER 121221. CONCLUSION: THE DAMAGE OBSERVED IS LIKELY DUE TO THE OVERTIGHTENING OF THE HEAD STRAP DURING SETUP. THE OPT542 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 OPT542 NASAL CANNULA IS SHIPPED TO THE CUSTOMER FULLY ASSEMBLED. IT 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 HEALTHCARE FACILITY IN (B)(6) REPORTED THAT TWO OPT842 OPTIFLOW NASAL CANNULAS WERE FOUND BROKEN WHEN TAKEN OUT OF THE PACKAGE.

    Description of Event or Problem · 1

    A HEALTHCARE FACILITY IN (B)(6) REPORTED THAT TWO OPT542 OPTIFLOW NASAL CANNULAS WERE FOUND BROKEN WHEN TAKEN OUT OF THE PACKAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    261168 OPTIFLOW NASAL CANNULA CAT CAT FISHER & PAYKEL HEALTHCARE LIMITED OPT542 121221

    Patients

    Seq Age Sex Outcome Treatment
    1