It was reported that during a set up for a cori assisted tka surgery, the real intelligence 24 in.Touch screen blacked out right before calibration and turned completely off and did not come back on remainder of case.They did notice it said in small letters in middle of screen ¿no signal detected¿ right before it turned completely off.The procedure was completed, without delay, using the tablet.Patient was not harmed as consequence of this problem.After case they tried to unplug monitor cord on back that would shut it off and plugged it back in, the monitor would show green light on bottom right hand corner of screen but would immediately turn orange and it would say ¿no signal detected¿ in middle of screen, which made them believe that the cord works fine and that it is the monitor that is defected.
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H10: internal complaint reference (b)(4).Section: h3, h6: the product, ri 24 in touch screen us, rob10003, s/n (b)(6) intended for use in treatment was not returned for evaluation; thus, a visual and functional evaluation could not be performed, and a relationship between the reported event and the device could not be determined.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.Although the reported problem was not confirmed, a factor that may have contributed to the reported symptom may be associated with a component/communication failure.Although no further containment or corrective action is recommended or required at this time, all complaints are monitored and trended through post market surveillance activities.If the product associated with this event is returned or provided at a future date, this evaluation will be reopened for investigation.
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