The reported issue involves two freedom onboard batteries that are reported under two separate medical device reports: (1) freedom onboard battery s/n (b)(4) (mfr report # 3003761017-2015-00224) and (2) freedom onboard battery s/n (b)(4) (mfr report # 3003761017-2015-00225).The customer reported that the patient said the freedom onboard battery had a low capacity.The customer also reported that the freedom onboard battery was exchanged for a new freedom onboard battery without any patient impact.Freedom onboard battery s/n (b)(4) was returned to syncardia for evaluation.The onboard battery s/n (b)(4) successfully passed visual inspections, and the battery was within the useful life period at the time of the customer-reported issue.During investigation evaluation, onboard battery s/n (b)(4) could not communicate with the smbus (system management bus) reader and, therefore, was determined to be inoperative.The smbus is the communication protocol used to communicate with the freedom onboard batteries.The root cause for onboard battery s/n (b)(4) being inoperative could not be determined without further destructive disassembly.The freedom onboard battery is designed as a disposable unit, and no further investigation was conducted.Risk to the patient was low because it would not prevent the freedom driver from performing its life-sustaining functions.The freedom driver has a redundant power source of external wall power, and patients are provided with several onboard batteries.Additionally, the patient is provided with additional onboard batteries.Because onboard battery s/n (b)(4) was inoperative, the battery was taken out of service.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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