(b)(4).Device history record investigation did not show issues related to complaint.A record assessment (fmea) was performed and no update is required.Device was received for evaluation.Visual and physical structural testing revealed no significant findings, beyond that inherent of day to day use.No obvious physical damage noted.Device passed power-on self-test and temperature display accuracy test.The device was prepared for the functional bench test (tp-7) where water, an adult breathing circuit (880-36kit), 10 lpm of air pressure, low compliance column is connected to the unit for a real time operational scenario.Device successfully negotiated all pre-operational self-tests again and was functioning real time for 2 hours.The unit functioned without interruption.The complaint cannot be confirmed.Functional testing did not reveal any operational anomalies.No corrective/preventative actions will be assigned.Teleflex will continue to monitor and trend for similar customer complaints on these devices.
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