Manufacturer's investigation conclusion: the reported event of the ¿controller screen went blank and white¿ was confirmed with the submitted reference photo.The submitted reference photo (controller) did captured an lcd display screen with no information with both pump running symbols illuminated.A root cause of the reported event could not be determined through this evaluation.Additional information communicated on 28jun2021 indicated the patient¿s family has an intention of returning the equipment for an evaluation; however, the time frame is unknown.The system controllers has not yet been retrieved.All available information for conducting this investigation was collected and no additional follow-up attempts will be performed.To date, the system controller (serial # (b)(6)) associated with the event was unavailable for an evaluation.The complaint file will close accordingly and will be reopened if pertinent information is received.Device history record indicated the device was manufactured in accordance to mfg and qa specifications.System controller (serial # (b)(6)) was shipped to the customer on 10may2020.Heartmate 3 patient handbook, cautions the users to ¿call your hospital contact if you think that, for any reason, any portion of your equipment is not functioning as usual, is broken, or you are uncomfortable with the operation of the equipment.Your hospital contact can check the equipment and order replacements, if needed.Do not try to repair anything yourself.¿ under section 5 ¿alarms and troubleshooting¿, all alarm conditions are addressed including ¿driveline disconnected¿ alarms.1.Immediately reconnect the driveline to the system controller and move the driveline safety lock on the system controller to the locked position.(see page 33.) it may take up to 10 seconds for the pump to start.2.Check that the modular in-line connector is secure.3.If alarm persists after reconnecting the driveline, press any button on the system controller to potentially resolve.4.If driveline is connected and alarm persists, replace the system controller with a programmed backup system controller.See page 63.5.Immediately call hospital contact if steps 1¿3 do not resolve the alarm.In section 2, under ¿the system controller self test¿, the system controller self test is loud and bright.All of the lights, symbols, and sounds come on and ¿self test¿ appears on the screen.Also, under ¿how your heart pump works¿, covers replacing the running system controller with a backup controller.Important warning information associated with the system controller exchange.Important! do not attempt to change your system controller without having a trained, competent caregiver at your side to assist.Follow all alarm instructions, including calling the hospital if instructed.Heartmate 3 instructions for use ¿replace any equipment or system component that appears damaged or worn¿.No further information was provided.The manufacturer is closing the file on this event.
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