H11:section a through f - the information provided by bd represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.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 under cesc rec 1511339.During evaluation, the reported issue of system shutting down unexpected was confirmed.The root cause of the failure was identified as a faulty internal battery.The device was serviced, tested, and returned to the customer.A history review of serial number (b)(6) showed no other similar product complaint(s) from this serial number.
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