(b)(4).The opt844 interface is used to deliver humidified oxygen to patients.The opt844 consists of a lightweight delivery tube which is connected to a rigid plastic base and soft nasal prongs (nasal interface).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 nares.Method: the complaint opt844 nasal cannula was returned to fisher & paykel healthcare china where photos of the complaint unit were taken.The photos were visually inspected.Results: visual inspection of the complaint unit revealed that the tubing of the cannula was found to be pulled out of the connector.The tubing was torn where it was assembled to the connector.The swivel grip was also found fully pulled out of the connector.Conclusion: it is most likely that the tubing became broken as a result of excessive pulling force being exerted on the device.All optiflow interfaces are inspected 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 user instructions which accompany the opt844 cannula 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.
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