The customer, a syncardia certified hospital, reported that the patient was plugged into the car d/c power when the freedom driver exhibited a fault alarm during an onboard battery exchange while supporting a patient.There was no reported adverse patient impact.The customer also reported that the patient was subsequently switched to a backup freedom driver.
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Visual inspection of the driver revealed external damage on the front housing, display cover, and fan cover.Internally, damage was found on the left and right speaker housing bosses, the main printed circuit board assembly (pcba), the speaker ribbon cables, and the piston cylinder assembly's (pca) scotch yoke.Furthermore, the secondary motor's cam follower was found to be out of the bottom dead center (bdc) position.The damage observed during the visual inspection is consistent with impact shock.The driver's alarm history was reviewed and revealed one new alarm, a 36 fault code.This alarm can produced during an onboard battery exchange or as a result of impact shock suffered by the driver while operating and causing power communication errors.This alarm is most likely the alarm reported by the customer.The driver in "as received" condition passed all sections of functional testing on both the primary and secondary motor systems.All ten freedom onboard batteries that were returned with the driver were individually evaluated and passed all functional testing.Additionally, an onboard battery exchange test was performed and the driver did not exhibit any alarms.During investigation testing, each device functioned as intended and there was no evidence of a device malfunction.The root cause of the customer-reported issue could not be conclusively determined.It is possible the alarm occurred because the driver experienced an impact shock, as evidenced by the damage observed during visual inspection, causing power communication errors.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.(b)(4) follow-up report 1.
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