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 scanner displaying vertical lines on the screen is confirmed.The back enclosure is cracked between the probe cable entry cover and the label.There are chips in the probe well of the back enclosure.The back enclosure is cracked by the tripod screw hole.The probe cable entry cover is cracked.The front enclosure is cracked on the top right corner.The power port cover is missing.The probe has a crack at the seam between the probe cap and probe handle.The device was serviced, tested, and returned to the customer.A lot history review (lhr) review is not possible, as the device is manufactured using a unique serial number and not by lot number.A history review of serial number (b)(4) showed no other similar product complaint(s) from this serial number.
|