(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: the complaint cannulae were not returned to fisher & paykel healthcare for evaluation.Instead ten unopened, unused cannulae from the same lot were provided by the hospital and were visually inspected.Results: the information provided by the customer suggests that the cannula tubing had become disconnected from the manifold, however no photographs were provided to confirm this.Visual inspection of the returned samples from the same lot revealed that there was no defect with any of the devices and the tubing was firmly attached to the manifold.Conclusion: without the devices to evaluate we cannot conclusively determine what had happened to cause the reported disconnection.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 opt946 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.
|