(b)(4).Product background: the opt980 optiflow + mask interface adapter is a patient interface used for delivery of humidified respiratory gases and allows for the connection of a heated breathing tube to a standard vented face mask or to a patient's tracheostomy.Optiflow + interfaces are designed for use with the airvo 2 series of humidification devices.The airvo 2 device is intended for use with spontaneously breathing patients who would benefit from receiving high flow warmed and humidified respiratory gases.The airvo 2 should not be used for life support purposes, and appropriate patient monitoring must be used at all times.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 complaint opt980 optiflow + mask interface adapter was received at fisher & paykel healthcare (f&p) in new zealand for investigation, where it was visually inspected.Our investigation is based on the information provided by the healthcare facility, our evaluation of the returned device and our knowledge of the product.Results: the healthcare facility reported that the tubing of an opt980 optiflow + mask interface adapter was found damaged and the patient developed a mucous plug.The patient was provided alternative therapy via a bag-valve mask and suctioning while the subject opt980 was replaced.It was further reported that the patient was not being monitored while they were using the subject opt980.Visual inspection of the returned opt980 revealed the tubing was torn next to the manifold.The remaining tubing was stretched and the film of the tubing at the site of damage was wrinkled, which indicates the damage was consistent with an external force being applied to the tubing.Conclusion: we are unable to determine the cause of the reported event.However, based on our knowledge of the product and our observation that parts of the tubing were stretched, the reported event was likely caused by the cannula being subjected to excessive force during use.It should also be noted that the patient was not being monitored while they were using the subject opt980.Manufacturing controls for the opt980 optiflow + mask interface adapter include inspections 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 opt980 would have met the required specifications.The user instructions which accompany the opt980 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."
"failure to use the set-up described above can compromise performance and affect patient safety.".
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