The system checkout log was reviewed and revealed five system check test failure alarms, thus confirming the customer-reported issue of the driver not passing system checkout.Further review indicated that the system check test failure alarms were due to the depletion of the 9v battery (voltage below acceptable limits).The root cause for the depleted 9v battery could not be conclusively determined, however, based on device tracking information, the driver sat idle for approximately one year and it is suspected that during this time, the 9v battery experienced a deep cell depletion.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.
|