Manufacturer's investigation conclusion: the reported event of damage to the black cable¿s connector nut was confirmed during evaluation of the returned heartmate 3 system controller (serial number: (b)(6).The controller¿s black power cable was still able to connect and partially lock into multiple power sources despite the observed damage.The controller was functionally tested and found to perform as intended.Additionally, a log file containing approximately 4 days of data (04apr2022 to 08apr2022 per timestamp) was downloaded for review, and no atypical events were observed.The root cause of the reported damage was unable to be conclusively determined through this analysis.Review of the device history record for the heartmate 3 system controller, serial number (b)(6), showed that the device was manufactured in accordance with manufacturing and qa specifications.Heartmate 3 patient handbook section 6 "equipment maintenance", describes how to care for and clean all equipment, including the system controller and its power cables.Heartmate 3 patient handbook section 10 entitled ¿safety checklists¿, provides checklists to assist the patient in performing routine maintenance of heartmate 3 lvad, including inspecting the system controller power cables for damage.The patient handbook also cautions the users to call their hospital contacts if they think, for any reason, any portion of their equipment is not functioning as usual, is broken, or they are uncomfortable with the operation of the equipment.No further information was provided.The manufacturer is closing the file on this event.
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