(b)(4).Method: the complaint rt114 adult inspiratory heated breathing circuit was not available to be returned to fisher & paykel healthcare in new zealand for investigation, however the hc550 heated humidifier that was used in the reported event was returned.Our investigation is thus based on the information provided by the customer, our knowledge of the product and performance testing tof the hc550 heated humidifier.Results: the subject hc550 heated humidifier passed all calibration and performance checks.No fault was found with the subject humidifier.Conclusion: without the return of the complaint breathing circuit, we are unable to determine the cause of the arcing.However, the information provided by the customer indicates that the arcing was confined to the pin heater wire connection inside the overmoulded heater wire plug.The heater wire adaptor (900mr806) is an electrical adaptor used for connecting a heated breathing circuit with the hc550 humidifier, and incorporates a surge and over-current protection circuitry.In the event of a power surge, the adaptor disconnects the heater wire for up to four seconds and the hc550 humidifier will alarm.The adaptor will then reconnect the heater wire and resume normal operation.The information provided by the customer indicated that the heater wire adaptor functioned as intended.The user instructions for the rt114 adulty inspiratory heated breathing circuit state the following: - check all connections are tight before use - set appropriate ventilator alarms.
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