The date of event was not provided by the complainant/reporter, the date reflected in this report is the date bd became aware of the event.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 since the customer got their scanner back they have gotten 2 blue screens was confirmed.The scanner would boot into blue screen after many attempts.The root cause of the reported issue is a ssd hard drive failure.A history review of serial number (b)(4) showed no other similar product complaint(s) from this serial number.
|