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 screen flickers on and off during use was unconfirmed.The scanner functions properly with no visual flickering or errors.The root cause of the reported failure is inconclusive as the reported issue could not be reproduced during evaluation.H3 other text : evaluation findings are in section h.11.
|