Manufacturer's investigation conclusion: the reported event of the system controller¿s white power lead being damaged was not confirmed.The system controller (serial number (b)(6)) was not returned for analysis, and no log files were associated with the reported event.Information regarding the controller was asked multiple times and further info about the controller was not provided.The root cause of the reported event was unable to be determined through this analysis.Review of the device history record for the system controller, serial number (b)(6), showed the device was manufactured in accordance with manufacturing and quality assurance specifications.The heartmate 3 patient handbook (rev.C, section 10 ¿safety checklists¿) instructs users to regularly inspect their equipment, including their system controllers, and to avoid using equipment that appears damaged.Users are encouraged to replace any equipment that appears damaged.The heartmate 3 patient handbook (rev.C, section titled "emergency contact list") cautions 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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