The customer reported that the patient heard a "funny noise" from his freedom driver.The customer also reported that the patient was subsequently switched to the backup freedom driver.There was no reported adverse patient impact.The freedom driver was returned to syncardia for evaluation.Visual inspection of the exterior revealed a missing rubber foot and a missing filter cover fastening screw.Visual inspection o the interior revealed foreign object debris (dust/dirt) in the battery wells and on the fan cover and exhaust fan none of the issues observed during visual inspection affected the performance of the freedom driver.The freedom driver passed all functional testing with no anomalies, alarms or unusual noises.The reported "funny noise" was not duplicated during testing.The freedom driver performed as intended, and there was no evidence of a device malfunction.The freedom driver was serviced, including removal of the foreign object debris, and passed all final performance testing.The reported issue posed a low risk to the patient because the freedom driver continued to perform its life-sustaining functions.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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