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 sr8 was visually inspected upon receipt and was found to be in good physical condition.The reported issue that the screen goes blank is unconfirmed.The sr8 functioned properly.The screen and ultrasound display did not go blank.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 (b)(4) showed no other similar product complaint(s) from this serial number.
|