Manufacturer's investigation conclusion: the reported event of vertical lines in the lcd screen was confirmed.The system controller, serial number (b)(6), returned for analysis.The controller then underwent testing and passed.No atypical alarms were produced during testing.Following preliminary testing, the lcd screen from the controller was swapped with a functional lcd.This resolved the lines in lcd issue.The line in the lcd is a known issue related to the lcd itself.This did not affect the controller¿s ability to display messages or provide power to the pump.The controller was able to support pump function for extended period of time.The root cause for the line in the lcd was conclusively determined to be due to an issue with the lcd display; however, a further root cause was not able to be conclusively determined through this analysis.Device history records were reviewed and showed no deviations from manufacturing or quality assurance specifications.The patient handbook and instructions for use (ifu) 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.Heartmate 3 instructions for use section 8-¿equipment storage and care¿ and heartmate 3 patient handbook section 6-¿caring for the equipment¿ explain how to properly take care and maintain the integrity of the system controller.No further information was provided.The manufacturer is closing the file on this event.
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