Manufacturer's investigation conclusion: the reported event of the controller not producing visual signals while a continuous sound/alarm was active was not confirmed.The submitted log file contained approximately 5 hours of data ((b)(6) 2022 from 4:21:02 to 9:12:16 per the timestamp).The log file data did not indicate any issues with the system controller.The reported alarm was not captured in the log file despite the date and time, on which the reported alarm activated, being captured in the log file; it was reported that the alarm activated on (b)(6) 2022 at approximately 9:00.There were no notable alarms throughout the log file.The pump maintained a speed above the low speed limit throughout the log file.The heartmate 3 system controller (serial number: (b)(6) ) was not returned for evaluation.Additional information provided stated that the alarm resolved by itself and that the cause of the alarm was unknown.Although not confirmed, it appears that the event of the controller not producing visual signals was not observed again.The root cause of the reported event could not be conclusively determined through this analysis.The device history records were reviewed and the records revealed that the heartmate 3 system controller, serial number (b)(6), was manufactured in accordance with manufacturing and quality assurance specifications.The heartmate 3 system controller was shipped to the customer on 08oct2019.Heartmate 3 patient handbook section 5, entitled ¿alarms and troubleshooting¿, and heartmate 3 instructions for use section 7, entitled ¿alarms and troubleshooting¿, cover all alarms (visual and audible), and the actions to take if the alarms cannot be resolved.Heartmate 3 patient handbook section 10, entitled ¿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.Heartmate 3 patient handbook 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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