The driver's alarm history was reviewed and did not reveal any recorded alarms.Only permanent alarms are recorded in the drivers alarm history as intermittent and / or recoverable alarms are not recorded in the driver alarm history.The driver passed all sections of functional testing.During a 48-hour observation run, the driver did not maintain the proper normotensive pressure values for left arterial pressure (lap).The root cause of the customer-reported intermittent fault alarms could not be conclusively determined.(h6: 3189, 4756, 213, 67).The root cause the freedom driver did not maintain the proper normotensive lap values during testing was determined to be a malfunction of the piston cylinder assembly.This malfunction is unrelated to the customer-reported issue.(h6: 3005, 4756, 180, 4307).Syncardia has a corrective and preventive action (capa) for the issue of freedom driver out of specification left arterial pressure (lap).Syncardia has completed its investigation and is closing this file.(b)(4) follow-up report 1.
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