(b)(4).Fisher & paykel healthcare (f&p) is currently in the process of completing our investigation.We will provide a follow up report upon completion of our investigation.Product background: the opt942 optiflow + adult nasal cannula is a nasal cannula patient interface for delivery of humidified respiratory gases, including those who are receiving nasal high flow therapy (nhf).The cannula consists of a lightweight delivery tube connected to a rigid plastic base and soft nasal prongs (nasal interface).This allows the device to be light weight and durable.The interface is held in place by a head strap and features a head strap clip which works in tandem with the tubing clip (attaches to the patient's clothing/bedding) to support the weight of the circuit and prevent the cannula being dislodged.Optiflow + interfaces are designed for use with the airvo 2 series of humidification devices and is also compatible with the f&p mr850 and 950 humidification system devices.Nhf therapy is intended for use with spontaneously breathing patients who would benefit from receiving high flow warmed and humidified respiratory gases nhf therapy should not be used for life support purposes, and appropriate patient monitoring must be used at all times.
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(b)(4).Product background: the opt942 optiflow + adult nasal cannula is a nasal cannula patient interface for delivery of humidified respiratory gases, including those who are receiving nasal high flow therapy (nhf).The cannula consists of a lightweight delivery tube connected to a rigid plastic base and soft nasal prongs (nasal interface).This allows the device to be light weight and durable.The interface is held in place by a head strap and features a head strap clip which works in tandem with the tubing clip (attaches to the patient's clothing/bedding) to support the weight of the circuit and prevent the cannula being dislodged.Optiflow + interfaces are designed for use with the airvo 2 series of humidification devices and is also compatible with the f&p mr850 and 950 humidification system devices.Nhf therapy is intended for use with spontaneously breathing patients who would benefit from receiving high flow warmed and humidified respiratory gases nhf therapy should not be used for life support purposes, and appropriate patient monitoring must be used at all times.Method: the complaint opt942 optiflow + adult nasal cannula was received at f&p in new zealand for investigation, where it was visually inspected.Our investigation is based on our evaluation of the subject device, information provided by the healthcare facility, previous investigations of similar complaints, and our knowledge of the product.Results: visual inspection of the opt942 optiflow + adult nasal cannula revealed that the tubing was damaged near the swivel connector and close to the manifold.The film of the tubing was wrinkled which indicates the damage was consistent with an external force being applied to the tubing.The tube had been pulled to an unintended extension.There were no patient consequences reported by the healthcare facility.Conclusion: our investigation was unable to determine the exact cause of the observed damage to the opt942 optiflow + adult nasal cannula.Based on our knowledge of the product the tubing was likely subjected to excessive force during patient use.Sections of the film were wrinkled and torn indicating that there has been force applied and the tube pulled to an unintended extension.In addition, the healthcare facility stated that they pulled on the tubing following the reported event, causing additional damage to the subject tube.F&p's manufacturing controls for the optiflow + tubing include inspections during production for visual defects including cracks, tears, moulding defects, contamination, inclusions, discoloration and stretching or deformation.The subject opt942 optiflow + adult nasal cannula would have met the required specifications.The user instructions which accompany the opt942 optiflow + adult nasal cannula show in pictorial format the correct placement and fitting of the cannula, including ensuring the head strap clip and the tubing clip are appropriately attached.The user instructions also state: - "do not crush or stretch tube, to prevent loss of therapy." - "ensure head strap clip is attached, to prevent cannula from being pulled out of the nares." - "cannula can become unattached if not used with the head strap clip." - "attach tubing clip to clothing/bedding to prevent cannula from pulling off face." - "appropriate patient monitoring must be used at all times.Failure to monitor the patient may result in loss of therapy, serious injury or death." - "failure to use the set-up described above can compromise performance and affect patient safety.".
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