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 display has a very grainy and ¿snowflake¿ image was confirmed; the probe displays a rain like image which is covering 75% of the viewing area.The root cause of the reported failure was identified as a probe failure.A history review of serial number dyauah027 showed no other similar product complaint(s) from this serial number.H3 other text : evaluation findings are in section h.11.
|