(b)(4).The opt980e optiflow + mask interface adapter is used to deliver humidified respiratory gases to patients.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 interface.Method: the two complaint opt980e optiflow + mask interface adapters were not returned to fisher & paykel healthcare (f&p) in new zealand.Result: the customer reported that two opt980e optiflow + mask interface adapters were "coming apart at the base of the tubing" during use.The customer later reported that the provided lanyard of the interface was not used.Conclusion: we were unable to determine the cause of the reported fault.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 disposed of.The subject interfaces would have met the specification at the time of production.The user instructions which accompany the opt980e optiflow + mask interface adapter 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." "do not soak, wash, sterilize, or reuse this product.".
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