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 artifacts on the ultrasound image was confirmed.There is a cut in the pad on the top of the probe which is causing the artifacts on the ultrasound screen.The root cause of the failure was identified as use-related damage.A history review of serial number dyayac020 showed no other similar product complaint(s) from this serial number.H3 other text : evaluation findings are in section h.11.
|