(b)(4).The opt870 adult tracheostomy interface is used to deliver humidified oxygen to patients via tracheostomy.The interface is held in place by a neck 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 tracheostomy tube.The complaint opt870 interface was returned to fisher & paykel healthcare (f&p) regional office for evaluation.Our investigation is based on the information provided by the customer, photos provided by the regional office in (b)(4), and our knowledge of the product.Results: visual inspection of the provided photos by regional office revealed that the tubing of the opt870 was pulled apart near the circuit connector and stretched near the manfifold.Conclusion: without the complaint device received in fisher & paykel healthcare (b)(4), we were unable to conclusively determine the cause of the reported failure.However, the damage was most likely caused by an excessive pulling force being exerted on the tubing by the patient or the care person.All optiflow interfaces are inspected during production for visual defects including cracks, tears, inclusions, discolouration and deformation.Any product that fails the visual inspection is rejected.The subject device would have met the required specification at the time of production.The user instructions accompanying opt870 adult tracheostomy interface state the following: "to ensure loading on tracheostomy tube is kept to a minimum, make sure lanyard is fitted appropriately." "do not crush or stretch tube.".
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