Follow-up to service technician was started to gather more information about the intervention and, in particular, whether both sides were tested, how long it took the machine to reach the set temperature and how many times and how long the unit was tested.No answers have been provided.A device service history review has been performed and identified that the unit was manufactured in 2018 and no other similar events have been reported.Although the hc3t presented no deviations during testing and not having received a response from the technician to the follow-up communication, it cannot be ruled out the customer has actually experienced the claimed problem and, therefore, the case has been assessed reportable as per cautelative approach.Considering all the above facts, it cannot be ruled out the failure experienced by the customer was temporary and may occur in the future as well and it can be due to a provisional deficiency of the compressor.No other specific action was currently deemed necessary, livanova maintains and document periodic customer events monitoring process in order to evaluate actions for products improvement.
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