(b)(4).The opt944 interface is used to deliver humidified oxygen to patients and consists of a lightweight delivery tube connected to a rigid plastic base and soft nasal prongs (nasal interface).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.Method: no complaint cannula was received, however and 198 sealed, unused cannulae were returned to fisher & paykel healthcare for evaluation.The unused samples were visually inspected and checked for defects.Results: visual inspection of the unused cannulae revealed no visible defects.Twelve of the unused cannulae were removed from the packaging and more closely inspected.No visible damage was found and it was not possible to detach the tubing from the swivel connectors.The swivels were found to be operational.Conclusion: we were unable to confirm the complaint as reported by the customer as no defects were found with the returned samples.All optiflow interfaces are inspected during production for visual defects including cracks, tears, inclusions, discolouration and stretching or deformation.Any product that fails the visual inspection is disposed of.The setup instructions in the user instructions which accompany the opt900 series nasal cannula include the following steps: - 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.The user instructions also contain the following warnings/cautions: - 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.
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