Ps(b)(4).Device 1: lot 2101297146, udi (b)(4), date of manufacturing: 09-18-2020 device 2: lot 2101557332, udi(b)(4), date of manufacturing: 03-18-2021 the opt944 optiflow + adult nasal cannula is an interface 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 opt944 optiflow + adult nasal cannulas were not returned to fisher & paykel healthcare (f&p) for evaluation.Our investigation is based on the information and photographs provided by the customer.Results: visual inspection of the provided photographs revealed that the tubing of one of the two complaint opt944 optiflow + adult nasal cannulas was stretched and pulled apart at the manifold.Conclusion: we are unable to determine the cause of the reported damages to the subject opt944 optiflow + adult nasal cannulas.However, the damage observed was likely caused by the tubing being pulled.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 rejected.The subject cannulas would have met the specification at the time of production.The user instructions which accompany the opt944 optiflow + adult nasal 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, to prevent loss of therapy." - "failure to use the set-up described above can compromise performance and affect patient safety.".
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