(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 not returned to fisher & paykel healthcare (b)(4) for evaluation.Our investigation is based on a photograph of one of the complaint devices and information supplied by the customer.Result: visual inspection of the provided photograph revealed that the tubing of the opt844 had been pulled out of the connector.The grip had also been pulled of the connector.Conclusion: previous investigations into this type of damage have shown that an excessive amount of force is required to damge the tubing in this way.The subject cannula would not have passed testing on the production line in a damaged condition.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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