Manufacturer's investigation conclusion: the reported event of atypical alarm silence button pressed events was able to be confirmed via review of the log file.The heartmate 3 system controller (serial number: (b)(6)) was returned for analysis, and log files were submitted for review and another was downloaded for review.A review of the submitted log files showed overlapping events spanning approximately 3 days ((b)(6) 2022 ¿ (b)(6) 2022, (b)(6) 2022 per timestamp).Events captured on (b)(6) 2022 took place in the testing labs at abbott.The silence alarm button pressed event was constantly active throughout the log files beginning on (b)(6) 2022 from 11:10:11 ¿ (b)(6) 2022 at 10:54:53.This event did not clear indicating that the silence alarm button may have been stuck in the pressed position.There were no faults or alarms active during these events.The driveline was disconnected on (b)(6) 2022 at 10:54:09 and the controller was shut off at 10:54:53.There were no other notable alarms active in the log file.Pump operation was not affected.The controller underwent preliminary and functional testing and passed.The controller was able to operate a mock loop with no alarms active.During further investigation, the controller was connected to a mock loop for an extended period of time in order to view the log files and reproduce the events in the log file.The controller log file taken did not show any irregular events.The silence alarm button was pressed multiple times during active alarms and while no alarms were active.The events were recorded in the log file and the button was functioning as intended.No further tests were conducted.The controller was able to function as intended.The root cause of the reported event was unable to be conclusively determined through this investigation.The device history records were reviewed for the system controller (serial number: (b)(6)) and was found to pass all manufacturing and qa specifications before being shipped to the customer on (b)(6) 2021.Heartmate iii instructions for use (rev.C) section 8 entitled ¿equipment storage and care¿ and heartmate iii patient handbook (rev.C) section 6 entitled ¿caring for the equipment¿ addresses how to properly care for and maintain the equipment for proper use.Heartmate iii instructions for use (rev.C) section 7 entitled ¿alarms and troubleshooting¿ and heartmate iii patient handbook (rev.C) section 5 entitled ¿alarms and troubleshooting¿ addresses how to properly interpret and troubleshoot all system alarm conditions, and the actions to take if the alarms cannot be resolved.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.No further information was provided.The manufacturer is closing the file on this event.
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