BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NASAL OXYGEN CANNULA

    MDR report key: 1963192 · Received January 18, 2011

    Report

    Report Number
    9611451-2011-00035
    Event Type
    Malfunction
    Date Received
    January 18, 2011
    Date of Event
    December 23, 2010
    Report Date
    December 24, 2010
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LIMITED
    Product Code
    CAT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE OPT544 INTERFACE IS USED TO DELIVER HUMIDIFIED OXYGEN TO PATIENTS. THE OPT544 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 COMPLAINT DEVICES WERE NOT RETURNED FOR INVESTIGATION, HOWEVER, THE HOSPITAL PROVIDED A PHOTOGRAPH OF ONE OF THE CANNULAS. THE PHOTOGRAPH SHOWS THAT THE PRONGS HAD SEPARATED FROM THE MANIFOLD, HOWEVER, THERE IS NO INDICATION OF ANY PRODUCT ABNORMALITIES. A FISHER & PAYKEL HEALTHCARE REPRESENTATIVE VISITED THE HOSPITAL SHORTLY AFTER THE COMPLAINT WAS REPORTED. THE HOSPITAL REPORTED TO THE REPRESENTATIVE THAT THEY WERE UNAWARE OF THE CAUSE OF THE DISCONNECTIONS. WITHOUT THE RETURN OF THE COMPLAINT DEVICE OR FURTHER INFORMATION FROM THE HOSPITAL, FISHER & PAYKEL HEALTHCARE IS UNABLE TO DETERMINE THE ROOT CAUSE OF THE DISCONNECTIONS. THE OPT544 INTERFACE IS SHIPPED TO THE CUSTOMER FULLY ASSEMBLED WITH THE NASAL PRONGS FIRMLY SEATED ON THE PLASTIC MANIFOLD. FISHER & PAYKEL HEALTHCARE CARRIED OUT TRAINING WITH THE HOSPITAL ON (B)(4) 2011. NO ADDITIONAL COMPLAINTS HAVE BEEN RECEIVED FROM THIS HOSPITAL IN RELATION TO THE OPTIFLOW CANNULAS. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). THE HOSPITAL REPORTED THE PRODUCT COMPLAINT TO A FISHER & PAYKEL HEALTHCARE REPRESENTATIVE. THE REPRESENTATIVE CONTACTED THE HOSPITAL TO REQUEST ADDITIONAL INFORMATION AND TO ARRANGE PRODUCT TRAINING WITH THE NURSING STAFF. FISHER & PAYKEL HEALTHCARE WILL PROVIDE A FOLLOW-UP REPORT UPON RECEIPT OF THE REQUESTED INFORMATION AND COMPLETION OF OUR INVESTIGATION.

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED VIA A FISHER & PAYKEL HEALTHCARE REPRESENTATIVE THAT TWO OPT544 NASAL OXYGEN CANNULAS DISCONNECTED FROM THE TUBING (ONE ON (B)(6) 2010 AND ONE ON (B)(6) 2010). THE HOSPITAL STATED THAT THEY ARE UNSURE WHAT CAUSED THE REPORTED DISCONNECTIONS. NO PATIENT CONSEQUENCES WERE REPORTED.

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED VIA A FISHER & PAYKEL HEALTHCARE REPRESENTATIVE THAT TWO OPT544 NASAL OXYGEN CANNULAS DISCONNECTED FROM THE TUBING (ON (B)(6) 2010). THE HOSPITAL STATED THAT THEY ARE UNSURE WHAT CAUSED THE REPORTED DISCONNECTIONS. NO PATIENT CONSEQUENCES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NASAL OXYGEN CANNULA CAT CAT FISHER & PAYKEL HEALTHCARE LIMITED OPT544 100714 (2)

    Patients

    Seq Age Sex Outcome Treatment
    1