The freedom home ac power supply is a component that enables the freedom driver to be plugged into an external power source.The freedom home ac power supply was not supporting a patient.The customer, a syncardia certified hospital, reported that the freedom home ac power supply had a broken connector.
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Visual inspection of the power supply revealed 4 missing rubber feet and a cracked hypertronics connector outer housing.During functional testing, the broken connector outer housing caused the connector to not latch properly and, therefore, caused the connector to un-mate with the power adapter assembly.The root cause of this damage could not be conclusively determined; however, it most likely occurred due to rough handling, or wear and tear of the product.This issue will be monitored and trended as part of the customer experience process.Syncardia has completed its investigation and is closing this file.(b)(4) follow-up report 1.
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