It was reported that while testing the computer it was found that it was not getting bootup.No video on screen.They tried resetting all connections on cpu, monitor.They reset the cpu, but still not getting bootup.It is unknown whether the event happened during surgery and if there was patient involvement.
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It was reported that while testing the computer during setup for a navio sawbone demo, it was found that it was not getting bootup.No video on screen.They tried resetting all connections on cpu, monitor.They reset the cpu, but still not getting bootup.No patient involved.No other complications were reported.
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H3, h6: the product, unknown navio robotics instrument, unkn06100502, 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.While all products meet required manufacturing specifications prior to release a serial number or lot number is required to link the device to a dhr or nc investigation.A complaint history review for similar reported/confirmed complaints concluded this was an isolated event.Although the reported problem was not confirmed, factors that may have contributed to the reported symptom may have been associated with a loose cpu.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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