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 the unit has a blue error screen and intermittently freezes was confirmed; the scanner randomly goes into the blue error screen.The root cause of the reported failure was identified as an internal hard drive failure.A history review of serial number (b)(6) 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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