(b)(4).The opt970e 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 trachea.The complaint opt970e was not returned to fph in (b)(6).Our investigation is accordingly based on the photograph of the subject device that was provided by the healthcare facility.Visual inspection of the photograph revealed that the tubing was disconnected from the manifold.The tubing was also observed to be stretched and partly torn where it had connected to the manifold.Based the photograph, the reported event mostly likely occurred as a result of excessive pulling force being exerted on the device.All optiflow interfaces are inspected during production for visual defects.Any product that fails the visual inspection is rejected.As the subject device had been in use for 2 weeks, this suggests that the reported damage occurred after release for distribution.Our user instructions that accompany the opt970e trachea interface state: to ensure loading and movement on tracheostomy tube is kept to a minimum, make sure the lanyard is secured appropriately.Do not crush or stretch tube, to prevent loss of therapy.Appropriate patient monitoring must be used at all times.
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