Manufacturer's investigation conclusion: the reported event of low voltage alarms was unable to be confirmed.The heartmate 3 system controller (serial number: (b)(6) ) was not returned for analysis; however, a log file was submitted ( (b)(4) ) for review that showed events spanning approximately 17 hours ( (b)(6) 2024 at 16:22:27 ¿ (b)(6) 2024 at 09:59:42 per timestamp).There were no notable alarms active in the log file that would indicate an issue with the system controller.Multiple good faith efforts were sent asking if the low voltage alarms were associated with depleted batteries, if the low voltage alarms activated while the patient was sleeping, if the alarms resolved, and if so how.To date, no response has been provided.A root cause for the reported event was unable to be conclusively determined through this analysis.The device history records were reviewed, and the records revealed the heartmate 3 system controller (serial number: (b)(6) ) was manufactured in accordance with manufacturing and qa specifications.Heartmate 3 instructions for use section 7 entitled ¿alarms and troubleshooting¿ and heartmate 3 patient handbook section 5 entitled ¿alarms and troubleshooting¿ addresses how to properly interpret and troubleshoot all system alarms, including low voltage alarms.Heartmate 3 instructions for use section 8 entitled ¿caring for the equipment¿ and heartmate 3 patient handbook section 6 entitled ¿caring for the equipment¿ addresses how to properly care for, maintain, and store the equipment for proper use.Heartmate 3 patient handbook and heartmate 3 instructions for use (ifu) under section 3, entitled ¿powering the system¿, describes the various ways to power the heartmate 3 lvas.These sections explain how to properly switch between power sources.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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