Ps339988.The opt870 adult tracheostomy interface is used to deliver humidified oxygen to patients via tracheostomy.The interface is held in place by a neck 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 tracheostomy tube.Method: the complaint opt870 interface was not returned to fisher & paykel healthcare (f&p) for evaluation.Our investigation is thus based on the information and photo provided by the customer, and our knowledge of the product.Results: visual inspection of the provided revealed a hole in the opt870 tube.Conclusion: without the complaint device, we were unable to conclusively determine the cause of the reported failure.However, the damage was most likely caused by tubing being punctured with a blunt object.All optiflow interfaces are inspected during production for visual defects including cracks, tears, inclusions, discolouration and deformation.Any product that fails the visual inspection is rejected.The subject device would have met the required specification at the time of production.The user instructions accompanying opt870 adult tracheostomy interface state the following: - "to ensure loading on tracheostomy tube is kept to a minimum, make sure lanyard is fitted appropriately." - "do not crush or stretch tube.".
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A distributor in (b)(6) reported on behalf of a healthcare facility, via a fisher & paykel healthcare (f&p) field representative, that the tubing of a opt870 adult tracheostomy interface was leaking air during use.It was also reported that there were some holes on the tube.There was no reported patient consequence.
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