BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADULT NASAL INTERFACE

    MDR report key: 5397923 · Received January 28, 2016

    Report

    Report Number
    9611451-2016-00028
    Event Type
    Malfunction
    Date Received
    January 28, 2016
    Date of Event
    December 28, 2015
    Report Date
    December 30, 2015
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LTD
    Product Code
    CAT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DA
    Reporter Occupation
    NURSE

    Narratives

    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: THE COMPLAINT NASAL INTERFACES HAVE NOT BEEN RETURNED TO FPH NEW ZEALAND FOR INVESTIGATION. THE INVESTIGATION (VISUAL INSPECTION) IS BASED ON A PHOTOGRAPH PROVIDED BY THE CUSTOMER. QUESTIONS IN REGARDS TO THE REPORTED COMPLAINT WERE SENT TO THE CUSTOMER, BUT NO ANSWER HAS BEEN RECEIVED. RESULTS: VISUAL INSPECTION OF THE PROVIDED PHOTOGRAPH REVEALED THAT THE LEFT SIDE OF FOUR NASAL CANNULAE AND THE RIGHT SIDE OF ONE NASAL CANNULA WAS BROKEN. LOT DATES WERE PROVIDED BY THE CUSTOMER FOR THE CANNULAE: 3X LOT 150623, MANUFACTURED ON 23 JUNE 2015; 2X LOT 150727, MANUFACTURED ON 27 JULY 2015. A LOT CHECK REVEALED NO OTHER COMPLAINTS OF THIS NATURE FOR LOT 150623 AND LOT 150727. CONCLUSION: THE CANNULAE WOULD NOT HAVE PASSED TESTING ON THE PRODUCTION LINE IN A DAMAGED CONDITION. WE NOTE THAT THE HOSPITAL REPORTED THAT THE DAMAGE OCCURED "WHEN TAKING THE CANNULAE ON THE PATIENT". THE DAMAGE TO THE INTERFACE IS MOST LIKELY CAUSED BY THE HOSPITAL STAFF PULLING ON THE CANNULA OR OVERTIGHTENING OF THE HEADSTRAP DURING SETUP ON THE PATIENT. ALL OPTIFLOW INTERFACES ARE INSPECTED DURING PRODUCTION FOR VISUAL DEFECTS INCLUDING CRACKS, TEARS, INCLUSIONS, DISCOLORATION AND STRETCHING OR DEFORMATION. ANY PRODUCT THAT FAILS THE VISUAL INSPECTION IS DISPOSED OF. OUR USER INSTRUCTIONS THAT ACCOMPANY THE OPT546 ILLUSTRATE THE PROCEDURE FOR FITTING THE OPTIFLOW NASAL CANNULA TO A PATIENT.

    Additional Manufacturer Narrative · 1

    (B)(4) WE ARE CURRENTLY IN THE PROCESS OF OBTAINING FURTHER INFORMATION FROM THE HOSPITAL TO DETERMINE IF THE COMPLAINT OPT844 OPTIFLOW NASAL CANNULAE CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. WE ARE ALSO ATTEMPTING TO OBTAIN THE SUBJECT COMPLAINT DEVICE FOR FURTHER INVESTIGATION. WE WILL PROVIDE A FOLLOW UP REPORT ONCE WE HAVE COMPLETED OUR EVALUATION.

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED VIA A FISHER & PAYKEL HEALTHCARE (FPH) FIELD REPRESENTATIVE THAT WHEN USING OPT844 NASAL CANNULAE, "THE RUBBER IN FRONT WAS GOING APART". NO PATIENT CONSEQUENCE WAS REPORTED.

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED VIA A FISHER & PAYKEL HEALTHCARE FIELD REPRESENTATIVE THAT WHEN USING OPT844 NASAL CANNULAE, "THE RUBBER IN FRONT WAS GOING APART". NO PATIENT CONSEQUENCE WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    54010 ADULT NASAL INTERFACE CAT CAT FISHER & PAYKEL HEALTHCARE LTD OPT844 150623

    Patients

    Seq Age Sex Outcome Treatment
    1