BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADULT NASAL INTERFACE

    MDR report key: 4889626 · Received July 2, 2015

    Report

    Report Number
    9611451-2015-00301
    Event Type
    Malfunction
    Date Received
    July 2, 2015
    Date of Event
    June 1, 2015
    Report Date
    June 3, 2015
    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). THE COMPLAINT OPT844 NASAL CANNULAE ARE EN ROUTE TO FISHER & PAYKEL HEALTHCARE (B)(6) FOR EVALUATION. WE WILL PROVIDE A FOLLOW UP REPORT UPON COMPLETION OF OUR INVESTIGATION.

    Additional Manufacturer Narrative · 1

    (B)(4). THE OPT844 INTERFACE IS USED TO DELIVER HUMIDIFIED OXYGEN TO PATIENTS. THE OPT844 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: FOUR OPT844 NASAL CANNULAE WERE RECEIVED AT FISHER & PAYKEL HEALTHCARE IN (B)(4). THREE DEVICES WERE FROM LOT 141127 (MANUFACTURED NOVEMBER 27 2014) AND ONE WAS FROM LOT 150211 (MANUFACTURED FEBRUARY 11 2015). THE RETURNED CANNULAE WERE VISUALLY INSPECTED. RESULTS: NO FAULT WAS FOUND WITH DEVICE 1. IN DEVICE 2, THE NASAL PRONG WAS FOUND DISCONNECTED ON ONE SIDE OF THE MANIFOLD. IN DEVICE 3, THE NASAL PRONG WAS FOUND LOOSE ON ONE SIDE OF THE MANIFOLD. DEVICE 4 WAS FOUND SEALED AND UNUSED WITH NO FAULT FOUND. A LOT CHECK REVEALED NO OTHER COMPLAINTS OF THIS NATURE FOR EITHER OF THE LOT NUMBERS PROVIDED. CONCLUSIONS: THE CANNULA MANIFOLD COMING LOOSE FROM THE NASAL INTERFACE CAN BE CAUSED BY TIGHTENING THE SILICONE BUCKLE TOO FIRMLY WHEN ADJUSTING THE HEADSTRAP. 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 PRODUCT ILLUSTRATE THE PROCEDURE FOR FITTING THE OPTIFLOW NASAL CANNULA TO A PATIENT.

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED THAT THE SILICONE STRAP DETACHED FROM AN OPT844 NASAL CANNULA, CAUSING LEAK. THE HOSPITAL ALSO STATED THAT THIS HAD HAPPENED WITH SEVERAL CANNULAE. THEY CONFIRMED THAT THERE WAS NO PATIENT CONSEQUENCE.

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED THAT THE SILICONE STRAP DETACHED FROM AN OPT844 NASAL CANNULA, CAUSING LEAK. THE HOSPITAL ALSO STATED THAT THIS HAD HAPPENEED WITH SEVERAL CANNULAE. THEY CONFIRMED THAT THERE WAS NO PATIENT CONSEQUENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    430704 ADULT NASAL INTERFACE CAT CAT FISHER & PAYKEL HEALTHCARE LTD OPT844 141127

    Patients

    Seq Age Sex Outcome Treatment
    1