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.During evaluation, the reported issue of abrupt shutdown was unconfirmed.The scanner ran with power on (battery only) for 24 hours without shutting down.It would shut down after the battery has run down to 0%.The root cause of the reported failure is inconclusive as the reported issue could not be reproduced during evaluation.A history review of serial number dydwac018 showed no other similar product complaint(s) from this serial number.H3 other text : evaluation findings are in section h.11.
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