(b)(4) method: the complaint pt101 airvo 2 humidifier was not returned to fisher & paykel healthcare for evaluation.Further information was retrieved from the healthcare facility.Our investigation is based on the information provided by the customer and our knowledge of the product.The healthcare facility reported that the patient was a covid-19 positive patient who was admitted into the emergency department with breathing difficulties, low spo2, diabetes and high blood pressure.The patient had hypoxia prior to set-up on the airvo 2 humidifier.On the day of the event, it was reported that the nurse was alerted to the oxygen desaturation by the patient's monitoring alarm and an error code e5 was displayed on the pt101 airvo 2 humidifier.The patient was then put on a nonrebreather mask.It was reported that the patient was later intubated.No further patient consequences were reported.Results: e5 error code may occur due to multiple factors including if the airvo 2 unit was dropped, shaken or exposed to water.When an e5 alarm is triggered, an audible alarm will sound and a visual alarm will display "fault e5" and "switch off the unit and then restart".Conclusion: without the complaint device, we are unable to determine the cause of the error code.However, the error code is likely due to subjecting the device to impact damage or exposure to water.As part of the investigation the patient's clinical condition was assessed, and it was noted that the patient was in critical condition prior to the event.The airvo 2 humidifier is designed to provide humidification therapy to spontaneously breathing patients who are not dependent on mechanical respiratory support.The airvo 2 user instruction specifies the following information: - the unit is not intended for life support.- appropriate patient monitoring must be used at all times.- use continuous oxygen monitoring on patients who would desaturate significantly in the event of disruption of their oxygen supply.- do not store or use the unit where it can fall or be pulled into water.If water has entered the unit enclosure, disconnect the power cord and discontinue use.- never operate the unit if: - it has been dropped or damaged, - it has a damaged power cord or plug, - it has been dropped into water.
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