The customer reported that the freedom driver exhibited a fault alarm while supporting a patient who was sitting in front of his computer.The customer also reported that the freedom onboard batteries were approximately 60% according to the patient.The customer also reported driver readings were within the patient's baseline.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 external and internal components revealed no abnormalities.The driver was tested and passed all pressure test requirements, which included cardiac output, right atrial pressure (rap), aortic pressure (aop), pulmonary arterial pressure (pap) and left atrial pressure (lap) performance metrics associated with nominal normotensive and hypertensive patient simulator settings.Review of the alarm history (eeprom) revealed a fault alarm code that is indicative of a potentially failing u22 pressure sensor on the main pcba (printed circuit board assembly) and is consistent with the alarm that the customer experienced.Further investigation of the main pcba confirmed that the root cause for the reported fault alarm was a failure of the pressure sensor (u22) on the main pcba.The driver will be serviced, including replacement of the main pcba.Syncardia initiated a corrective action (capa) to address the issue of u22 pressure sensor failures.The capa is in process.This failure mode posed a low risk to the patient because it did not prevent the freedom driver from performing 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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