(b)(4).Method: the complaint bc163-10 bubble cpap system was not returned to fisher & paykel healthcare (f&p) for evaluation.Our investigation is based on the information provided by the customer and knowledge of our product.Result: the customer reported that the cpap probe of a bubble cpap generator was loose.Conclusion: without the complaint devices, we are unable to determine the cause of the reported fault.The existing design of the cpap probe is intended to be adjustable, which leads to the possibility of inadvertent movement.We note that there is a physical stop in the bubble cpap probe, to prevent the pressure from exceeding 10cmh20, and that a pressure manifold is used with the breathing circuit, to reduce the risk of unsafe circuit pressure.The user instructions that accompany the bubble cpap system kit illustrate in pictorial format the correct set-up and proper use of the bubble cpap generator.It also states the following: - "always use pressure monitoring to verify that the patient is receiving the prescribed cpap level." - "regularly observe the cpap generator for bubbling.If bubbling is not observed, check for and minimize the air leaks in the system and at the patient.If air leaks have been minimized, air flow may be increased to achieve continuous bubbling.".
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