BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADULT NASAL CANNULA

    MDR report key: 2055046 · Received April 13, 2011

    Report

    Report Number
    9611451-2011-00232
    Event Type
    Malfunction
    Date Received
    April 13, 2011
    Date of Event
    March 16, 2011
    Report Date
    March 17, 2011
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LIMITED
    Product Code
    CAT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE COMPLAINT OPT546 ADULT NASAL CANNULAS ARE EN ROUTE TO FISHER & PAYKEL HEALTHCARE FOR INVESTIGATION. WE WILL PROVIDE A FOLLOW-UP REPORT ONCE WE RECEIVE THE COMPLAINT DEVICES AND HAVE COMPLETED OUR INVESTIGATION.

    Additional Manufacturer Narrative · 1

    (B)(4). METHOD: TWO OPT546 ADULT NASAL CANNULAS WERE RETURNED TO FPH IN (B)(4) FOR INSPECTION. BOTH WERE VISUALLY INSPECTED FOR DAMAGE. RESULTS: NO FAULT WAS FOUND WITH THE FIRST COMPLIANT DEVICE, WHICH WAS STILL SEALED WHEN RECEIVED. HOWEVER, VISUAL INSPECTION OF THE THE SECOND COMPLAINT DEVICE, WHICH WAS RETURNED UNSEALED, REVEALED THAT THE CANNULA MANIFOLD WAS NOT FULLY SEATED IN THE NASAL INTERFACE. A LOT CHECK REVEALED TWO OTHER COMPLAINTS OF THIS NATURE FOR LOT NUMBER 100921. CONCLUSION: THE OPT546 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 REPORTED FAULT CAN BE CAUSED BY THE SILICON BUCKLE BEING TIGHTENED TOO FIRMLY WHEN THE HEAD STRAP IS ADJUSTED, CAUSING THE CANNULA MANIFOLD TO BECOME LOOSE AND THE NASAL PRONGS TO COME APART FROM THE MANIFOLD. THE OPT546 NASAL CANNULA IS HELD IN PLACE BY A HEAD STRAP AND 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. IF THE LANYARD IS NOT USED DURING THERAPY, THE CANNULA MANIFOLD WILL BE MORE SUSCEPTIBLE TO A PULLING FORCE AND EVENTUALLY BECOME LOOSE FROM THE NASAL INTERFACE. (B)(4).

    Description of Event or Problem · 1

    A HEALTHCARE FACILITY IN (B)(6) REPORTED THE FOLLOWING TO A FISHER & PAYKEL HEALTHCARE (FPH) FIELD REPRESENTATIVE INVOLVING AN OPT546 ADULT NASAL CANNULA: "IF SOME TRACTIONS ARE APPLIED ON THE NASAL CANNULA'S, THEN THE SOFT PART SEPARATED FROM THE HARD PART OF THE NASAL PRONG. THE FLOW WHICH IS INTENDED IN THE NOSE, IS GOING NOT INTO THE NOSE BUT ESCAPES ALONG THE NOSE. THIS WAY AND WE WILL MISS THERAPY". NO PATIENT CONSEQUENCE WAS REPORTED AS A RESULT OF THIS INCIDENT.

    Description of Event or Problem · 1

    A HEALTHCARE FACILITY IN (B)(6) REPORTED THE FOLLOWING TO A FISHER & PAYKEL HEALTHCARE (FPH) FIELD REPRESENTATIVE INVOLVING AN OPT546 ADULT NASAL CANNULA: "IF SOME TRACTIONS ARE APPLIED ON THE NASAL CANNULA'S, THEN THE SOFT PART SEPARATED FROM THE HARD PART OF THE NASAL PRONG. THE FLOW WHICH IS INTENDED IN THE NOSE, IS GOING NOT INTO THE NOSE BUT ESCAPES ALONG THE NOSE. THIS WAY AND WE WILL MISS THERAPY." NO PATIENT CONSEQUENCE WAS REPORTED AS A RESULT OF THIS INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ADULT NASAL CANNULA CAT CAT FISHER & PAYKEL HEALTHCARE LIMITED OPT546 100921

    Patients

    Seq Age Sex Outcome Treatment
    1