The real intelligence tracking camera, part number rob10025, s/n (b)(6), intended for use in treatment was not returned for evaluation; thus, a visual and functional evaluation could not be performed, however, a relationship between the reported event and the device was confirmed, as log files provided by the customer confirmed the complaint.An assessment of log files confirmed that the camera warming message was present.A review of manufacturing and service records indicate the device met all specifications upon release into distribution.A complaint history review for similar reported/confirmed complaints has identified prior events.The complaint was confirmed; the most likely cause of this event is software parameters of the device.As a part of corrective actions, a wider temperature threshold was set.If the product associated with this event is returned or provided at a future date, this evaluation will be reopened for investigation.
|