Manufacturer's investigation conclusion: the reported event of difficulty in reading device parameters on lcd screen was confirmed.The log file spanned approximately 16 days ((b)(6) 2020 to (b)(6) 2020 per the timestamp).There were no events related to the log file.Initial evaluation of the returned hm3 system controller, serial (b)(6), revealed a damaged lcd screen that made device parameters difficult to read.The lcd was replaced with a test lcd resolving the issue.The controller was functionally tested and was connected to a mock circulatory loop for an extended period of time without any issue.The damaged lcd did not affect the functionality of the controller.A root cause of the reported event was not determined through this analysis.Device history records were reviewed and showed no deviations from manufacturing or qa specifications.(b)(6) was shipped to the customer on 31jul2018.The patient handbook 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.Heartmate iii instructions for use section 8 entitled ¿equipment storage and care¿ and heartmate iii patient handbook section 6 entitled ¿caring for the equipment¿ addresses how to properly care for, maintain, and store the equipment for proper use.No further information was provided.The manufacturer is closing the file on this event.
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