The electronic patient data file was reviewed and revealed five emergency battery alarms, thus confirming the customer-reported issue of the driver not passing system checkout because of a dead emergency battery.Investigation testing determined that the emergency battery was severely depleted.The root cause for the depleted emergency battery could not be conclusively determined based upon the information provided, however, the root cause of the customer-reported issue was an unrecoverable depletion of the emergency battery.This issue will continue to be monitored and trended as part of the customer experience process.Syncardia has completed its evaluation and is closing this file.(b)(4) follow-up report 1.
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