Manufacturer's investigation conclusion: the heartmate ii system controller, serial (b)(6), was returned for analysis with the backup battery, serial (b)(6)following the reported event of fluid ingress.The returned backup battery was evaluated with the controller under mfr # 2916596-2021-05383.The 11v battery was inspected and accepted into storage location on 22jul2019.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.Heartmate ii instructions for use section -¿equipment storage and care¿ and heartmate ii patient handbook section -¿caring for the equipment¿ explain how to properly maintain the integrity of the system controller.No further information provided.The manufacturer is closing the file on this event.
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