The device was evaluated at the user facility.A complete check of the system did not find any anomalies.All values are within specification.The reported event was not duplicated and the system log does not show the event.A review of the device history record was completed and the device met specifications.Based on all available information, no causal factors can be determined and no conclusion can be drawn.The lot history, trend analysis, risk analysis and/or directions for use review were considered acceptable, with the product performing within anticipated rates.No corrective action required.If additional information from the user facility is received, the investigation will be reopened.No further investigation is necessary at this time.
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