BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OPTIFLOW NASAL CANNULA

    MDR report key: 3760372 · Received April 20, 2014

    Report

    Report Number
    9611451-2014-00349
    Event Type
    Malfunction
    Date Received
    April 20, 2014
    Report Date
    March 20, 2014
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LTD
    Product Code
    CAT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). METHOD: THE COMPLAINT OPT546 ADULT OPTIFLOW CANNULA WAS NOT RETURNED TO FISHER & PAYKEL HEALTHCARE FOR EVALUATION. THEREFORE, OUR INVESTIGATION IS BASED ON THE INFORMATION PROVIDED BY THE HOSPITAL, INVESTIGATION OF SIMILAR COMPLAINTS AND OUR KNOWLEDGE OF THE PRODUCT. RESULTS: THE HOSPITAL REPORTED THAT THE PATIENTS HAD NO COMFORT ISSUES. A LOT CHECK COULD NOT BE PERFORMED AS THE LOT INFORMATION WAS NOT PROVIDED. CONCLUSION: WITHOUT THE RETURN OF THE COMPLAINT DEVICE WE ARE UNABLE TO DETERMINE THE CAUSE OF THE REPORTED PROBLEM. HOWEVER, OVER TIGHTENING THE HEAD STRAP OR INCORRECT SIZING OF THE CANNULA MAY CAUSE PRESSURE SORES. THE USER INSTRUCTIONS THAT ACCOMPANY THE OPT546 ADULT OPTIFLOW CANNULA STATE THE FOLLOWING: "ENSURE NASAL CANNULA IS SIZED CORRECTLY AND DOES NOT CREATE A SEAL IN THE NARES." SINCE THE REPORTED INCIDENT AN FPH REPRESENTATIVE HAS SCHEDULED A VISIT TO THE HOSPITAL TO ANSWER ANY QUESTIONS AND TO PROVIDE ADDITIONAL TRAINING ON THE CORRECT SIZE AND FITTING OF THE ADULT OPTIFLOW CANNULA.

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED THAT THE OPT546 ADULT OPTIFLOW CANNULA WAS CAUSING PRESSURE ULCERS ON THE PATIENT'S EARS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    239186 OPTIFLOW NASAL CANNULA CAT CAT FISHER & PAYKEL HEALTHCARE LTD OPT546 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1