(b)(4).The complaint pt100 myairvo humidifier was not received for evaluation.F&p endeavoured to obtain further information about the chain of events.The customer was also asked to check the subject myairvo to confirm whether there was any malfunction.No response was received from the customer.We are unable to determine the cause of the reported fault as we did not receive the complaint device or additional information from the customer.The customer had informed us that the patient did not receive therapy for 8 hours; this implies that they had not checked on the patient during that 8 hour period.The airvo power fail alarm would have sounded for at least 120 seconds in the event of a power outage and would have then stopped functioning, as it relies on a power source to operate.As the patient was not checked on, it cannot be confirmed that the alarm did not sound, it is possible that the customer simply did not hear the alarm.
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