Manufacturer's investigation conclusion: the reported event of the 14-volt battery leaking was confirmed via damage observed on its contacts upon arrival; however, the reported event of the battery not functioning properly was not confirmed.The returned 14-volt battery (serial number (b)(6)) was observed to have fluid damage/corrosion on most of its contacts upon arrival correlating to the reported leak.The 14-volt battery was functionally tested alongside known working test equipment and was found to perform as intended despite the observed damage.No log files were associated with the reported event.The root cause of the reported event was unable to be conclusively determined through this analysis.Device history records (dhr) reside with the original equipment manufacturer (oem).However, the battery was observed to have passed all initial manufacturing tests per the greatbatch manufacturing datasheet.The heartmate 3 patient handbook (rev.D) instructs users on how to properly use, charge, and calibrate 14-volt batteries.If a red light status becomes active on the ubc while the battery is charging, users are advised to not use that battery.The patient handbook also instructs users on how to check the current relative charge of the 14-volt batteries.Two batteries are expected to power the system for approximately 17 hours, and this can vary depending on activity level.The heartmate 3 patient handbook (rev.D, section 10 ¿safety checklists¿) instructs users to regularly inspect their equipment, including their 14-volt batteries, and to avoid using equipment that appears damaged.Users are encouraged to replace any equipment that appears damaged.The heartmate 3 patient handbook (rev.D, section titled "emergency contact list") 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.
|