(b)(4).The optiflow thrive system is not sold in the usa but it is similar to a product sold in the usa.The 510(k) for that product is k983112.The optfilow thrive system is indicated for use in the hospital during peri-intubation, peri-extubation, procedural sedation and post-anaesthesia care.It is intended to be used in conjunction with the mr810 humidifier to deliver humidified oxygen.In the reported event, the customer stated that while the diathermy utilized biopsy was being performed, a fire was started when the diathermy needle made contact with a piece of gauze on the patient's face.The fire was extinguished quickly.The clinician thought that reducing oxygen flow may reduce the risk of fire and subsequently reduced the flow of the oxygen through the nasal interface, as the benefits of using nasal high-flow outweighed the risks relative to the alternatives.It is unknown whether any alcohol skin preparation had been utilized.This case was reported to fisher & paykel healthcare because the optiflow thrive system was in use at the time of the fire occurring.The optfilow thrive system performed as expected.A fisher & paykel healthcare field representative directly contacted the customer after the reported event was received to arrange further training on the correct use and setup of the optiflow thrive system.Consequently, our optiflow thrive system user instructions contain the following warning: "exposure to oxygen increases the risk of fire.Use of this system near any ignition source, including electrosurgery, electrocautery, or laser surgery instruments may result in patient injury or death.".
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