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 an unclear picture that is faded and fuzzy was unconfirmed.The ultrasound image is comparable to 20mm gt probes.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 dyasac023 showed no other similar product complaint(s) from this serial number.H3 other text: evaluation findings are in section h11.
|