The device was returned and an evaluation confirmed the complaint.Review of the device data logs revealed an internal battery alarm.The internal battery was replaced to address the issue.The device was serviced and fully tested before it was returned to the customer.Based on all available evidence and complaint investigations of a similar nature, the investigation determined that the reported complaint was due to a software issue.Resmed's risk analysis for the failure mode concludes that the risk is acceptable.(b)(4).
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