The freedom ac power supply is a component that enables the freedom driver to be plugged into an external power source.The customer reported that the freedom ac power supply had a broken connector.The customer also reported that the patient was provided with a replacement ac power supply.There was no reported adverse patient impact.The freedom ac power supply was returned to syncardia for evaluation.Visual inspection of the returned freedom ac power supply revealed a broken strain relief and a cracked connector cover.The broken strain relief can occur as part of normal wear and tear.A cracked connector cover can occur as a result of misuse, such as being dropped or stepped on.The freedom ac power supply functioned as intended during failure investigation testing, and there was no evidence of a device malfunction.The customer-reported issue posed a low risk to the patient because it would not prevent a freedom driver from performing its life-sustaining functions.Because of the broken strain relief and cracked connector, freedom ac power supply s/n (b)(4) 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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