It was reported that, before a navio procedure, the camera would not connect during the hardware connection phase when launching a case.The busy circle kept spinning while both green lights on camera were solid.They did some troubleshooting and determine this camera will not connect to either machine.The other camera at facility had no problem connecting with both machines.No patient was involved at the moment.It was swapped for its backup to proceed without delays.No other complications were reported.
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H3, h6: the reported device, intended for use in treatment.Was not returned to the designated complaint unit for independent evaluation, thus visual inspection and functional testing could not be performed.A review of manufacturing and service records indicate the device met all specifications upon release into distribution.A complaint history review concluded this was a repeat issue.A relationship, if any, between the subject device and the reported event could not be determined.A factor that may have contributed to the reported complaint include, 1) the device may have experienced component failure.No containment or corrective actions are recommended at this time.If the product associated with this event is returned at a future date, this evaluation will be reopened for investigation.
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