(b)(4).The opt970 optiflow plus tracheostomy direct connection 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 trache.Method: the complaint opt970 optiflow plus tracheostomy direct connection interface was not received at fisher & paykel healthcare (f&p) for evaluation.Our investigation is thus based on the information and photograph provided by the customer, previous investigations of similar complaints, and our knowledge of the product.Result: visual inspection of the provided photograph revealed that the tubing of an opt970e optiflow plus tracheostomy direct connection interface was detached from the swivel connector.The customer also noted that the patient tried to remove the cannula during use.Conclusion: based on the information provided, the reported damage was caused by the patient puling at the tube of the opt970e optiflow plus tracheostomy direct connection interface.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 subject interface would have met the specification at the time of production.Our user instructions that accompany the opt970 optiflow plus tracheostomy direct connection interface states: 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, to prevent loss of therapy.Failure to use the set-up described above can compromise performance and affect patient safety.
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A healthcare facility in (b)(6) reported on behalf of a distributor, via a fisher & paykel healthcare (f&p) field representative, that the tubing of an opt970 optiflow plus tracheostomy direct connection interface was broken.The customer noted that the patient tried to remove the cannula during use.There was no reported patient consequence.
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