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: device was returned with no alleged deficiency reported.During evaluation, there was interference found at the bottom of the ultrasound image window.The root cause of the bad image box is due to an internal failure in the probe.The probe was discarded due to being irreparable.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.
|