(b)(4).The opt946 optiflow + adult nasal cannula is an interface used to deliver humidified oxygen to patients and consists of a lightweight delivery tube connected to a rigid plastic base and soft nasal prongs (nasal interface).The interface is held in place by a head strap and features a head strap clip which works in tandem with the tubing clip (attaches to the patient's clothing/bedding) to support the weight of the circuit and prevent the cannula being dislodged.Method: the complaint opt946 optiflow + adult nasal cannulas were not returned to fisher & paykel healthcare (f&p) for evaluation.Our investigation is based on the information and photographs provided by the customer, and our knowledge of the product.Results: visual inspection of the photographs revealed that the tubing was found to be degraded.Conclusion: without the complaint device, we are unable to determine the cause of the failure mode.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 rejected.The subject cannula would have met the specification at the time of production.The user instructions which accompany the opt946 optiflow + adult nasal cannula show in pictorial format the correct placement and fitting of the cannula and also warn: - "appropriate patient monitoring must be used at all times.Failure to monitor the patient may result in loss of therapy, serious injury or death." - "do not crush or stretch tube, to prevent loss of therapy." - "failure to use the set-up described above can compromise performance and affect patient safety." - "for single patient use only.Reuse may result in transmission of infectious substances.Attempting to reprocess will result in degradation of materials and render the product defective." - "do not soak, wash or sterilize.".
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