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 misaligned probe was confirmed.The sr8 was visually inspected, and physical damage was found- battery switch cover broken off.The root cause of the reported failure was identified as software related, after reimaging the scanner worked as designed.A history review of serial number (b)(4) showed no other similar product complaint(s) from this serial number.
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