Date of event: (b)(6) 2018.Date of report: 09july2019.The customer's biomedical engineer evaluated the batteries but it showed no evidence of overheating.The unit was ran and the reported issue could not be repeated.The battery was replaced with a new one and tested.The unit was left running for observation and found to meet manufacturer's specifications.Unit was tested and returned to service.Old battery was recycled and not available for return.This mdr has been reassessed as reportable after a request from the fda on march 1, 2019 to review complaints from 29 nov 2017 to 29 nov 2018.As this has been reassessed, it will appear to be a late mdr.
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