Manufacturer's investigation conclusion: the reported event of the 14v li-ion battery not being accepted for charge was unable to be confirmed.The 14v li-ion battery (serial number: (b)(4)) was returned for analysis and was functionally tested and passed.The battery was accepted for charge.The battery was able to operate a mock loop and functioned as intended.The root cause of the reported event was unable to be conclusively determined through this investigation.The device history records for the 14v li-ion battery (serial number: (b)(4)) were unable to be reviewed due the records being maintained by the vendor and are unavailable.Heartmate iii instructions for use (ifu) rev.C ¿powering the system¿ and the heartmate iii patient handbook rev.C ¿powering the system¿ addresses how to properly use the 14v battery clips and 14v li-ion batteries.Heartmate iii ifu rev.C ¿equipment storage and care¿ and heartmate iii patient handbook rev.C ¿caring for the equipment¿ addresses how to properly care for and maintain the equipment for proper use.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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