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 abrupt shutdown was confirmed; the reported issue of an ec-111 error is confirmed.Although the error did not occur during the assessment, the error was found in the logs multiple times.The sr8 was visually inspected upon receipt and was found to be in good physical condition.The root cause of the reported failure was identified as due to a general system error.A history review of serial number (b)(4) showed no other similar product complaint(s) from this serial number.
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