It was reported that, during software installation, they went to load 1.4.3 software after verifying that no upgrade had been made on the software.The loading of the software worked as usual until the screen to enter the password and asked for "navio master password".They tried two different passwords and nothing worked.They tried to reload the software again from the beginning.After asking to load the optimus, they received a purple screen asking to load the software if usb drive was installed.They selected yes and one line proceeded and then system froze.They reload the software 1.4.1.No case involved; therefore, there was no patient involvement.
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H3, h6: the real intelligence cori application usb, intended for use in treatment was returned for evaluation.A relationship between the reported event and the device was established.Nothing was identified visually that contributed to the reported problem.A functional evaluation was completed.The reported problem was confirmed.The application usb will not function.Non-functioning usb: idb install does not function, app: graphics is less, selected yes, no such file or directory, ok but immediately stalls.A photo was provided as evidence for review.The 1.4.3 usb photo shows that the installation hung up just after pressing yes to the optimus installer dialog box."/home/installation-scripts/installnavio: no such file or directory", "[ok] is returned.The most likely cause of this event is related to the usb build process.A change was made to the procedure to correct the process.A review of manufacturing records indicate the software met all specifications upon release into distribution.A complaint history review for similar reported/confirmed complaints found similar events.A historical escalation event review was completed.A review of prior escalation actions found no actions applicable to the scope of the reported complaint.The failure mode and associated risk have been anticipated within the risk file and the documented risk level is still adequate.Although no further containment or corrective action is recommended or required at this time, the failure mode will continue to be closely monitored through complaint investigation and trended through post market surveillance activities.
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