The following were reviewed as part of this investigation: patient severity, applicable previous investigation(s), sample (if available), applicable fmea documents, labeling, and applicable manufacture records.Based on a review of this information, the following was concluded: the device was returned to the service facility for evaluation.During evaluation, the reported issue of battery fails to hold a charge and system fails to run on battery was confirmed.The root cause is an internal failure in the lithium-ion battery.The scanner was charged to 100%, when the ac adaptor was removed the scanner shut down.The device was serviced, tested, and returned to the customer a lot history review (lhr) review is not possible, as the device is manufactured using a unique serial number and not by lot number.A history review of serial number (b)(6) showed no other similar product complaint(s) from this serial number.
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