This (b)(6) hospital ac power supply was not in patient use.The (b)(6) hospital ac power supply is a component that enables the freedom driver to be plugged into an external power source.The customer reported that the green connector of the freedom hospital ac power supply was difficult to insert and did not securely connect into the freedom power adaptor.The hospital ac power supply was returned to syncardia for evaluation.Visual inspection revealed that the cable connector cover was not in the correct orientation.This prevented the hospital ac power supply from making a proper connection to provide power to a freedom power adaptor or battery charger.The ac power supply cable was disassembled, the connector key slot was aligned with the connector cover key tab and the correct mating configuration was obtained.After the ac power supply cable was reassembled, the hospital ac power supply passed all required functional testing.The root cause for the observed issue was the incorrect orientation of the connector cover on the freedom hospital ac power supply, which may result from processes at the component supplier or syncardia.Syncardia has implemented process controls to identify this issue prior to release of freedom ac power supplies to finished goods and to eliminate the potential for recurrence.The occurrence rate for this issue is extremely low and there is no impact to the patient.The incorrect orientation of the connector cover is immediately identifiable by hospital personnel when preparing the freedom driver for patient use per section 7.5 of f-900013-en, freedom driver system operator manual.The freedom driver system includes multiple power sources and power supply accessories such that operation of the driver is not impacted by this issue.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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