The customer reported that the freedom driver exhibited a fault alarm while supporting a patient.The customer also reported that the reason for the fault alarm was "unclear." the patient subsequently went to the hospital and switched to a companion 2 driver.There was no reported adverse patient impact.The freedom driver was returned to syncardia for evaluation.During incoming investigation testing, the driver met all performance testing, which included normotensive and hypertensive settings, with no anomalies or alarms.The customer-reported fault alarm could not be reproduced during incoming investigation testing.Review of the electronic data revealed two permanent faults: secondary motor voltage too high and cardiac output too low for long enough to be permanent time-out.The secondary motor voltage too high was produced during functional testing as part of routine service/manufacturing for the driver.The cardiac output too low for long enough to be permanent time-out fault was likely the alarm that the customer experienced, which could be caused from kinking of the drivelines or patient hypertension or hypervolemia.The driver performed as intended, and there was no evidence of a device malfunction.The customer-reported issue could not be reproduced.Results from failure investigation testing indicate that the customer-reported fault alarm posed a low risk to the patient because the driver continued to perform its life-sustaining functions.The freedom driver was serviced and passed all functional and performance testing before being placed into finished goods.This issue will continue to be monitored and trended as part of the customer experience process.Syncardia has completed its evaluation of this complaint and is closing this file.
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