(b)(4).The opt970 optiflow + tracheostomy direct connection is a patient interface used for delivery of humidified respiratory gases directly into the 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 subject opt970 optiflow + tracheostomy direct connection interface was not returned to fisher & paykel healthcare (f&p) for evaluation.Our investigation is based on the information and the photograph provided by the customer, and our knowledge of our product.Results: the customer has stated that the tubing of an opt970 optiflow + tracheostomy direct connection was found damaged.Visual inspection of the provided photograph confirmed that the tubing was damaged.Conclusion: without the return of the subject opt970 optiflow + tracheostomy direct connection, we are unable to determine the cause of the reported damage.However, based on our knowledge of the product and our observation that parts of the tubing were damaged, the reported event was likely caused by the cannula being subjected to excessive force during use.Manufacturing controls 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 opt970 optiflow + tracheostomy direct connection interface would therefore have met the required specifications.Our user instructions that accompany the opt970 optiflow + tracheostomy direct connection interface show in pictorial format the correct placement and fitting of the cannula, including ensuring the lanyard is secured properly.The user instructions also warn: - do not crush or stretch tube, to prevent loss of therapy.- failure to use the set-up described above can compromise performance and affect patient safety.
|