Description of Event or Problem · 1
IT WAS REPORTED THAT A PHYSICIAN'S DELL X5 HANDHELD DEVICE WAS NOT FUNCTIONING PROPERLY. THE HANDHELD WOULD FREEZE ON THE INTERROGATION SCREEN AND WOULD NOT PROGRESS PAST THAT SCREEN. A COMPANY REP WENT TO THE PHYSICIAN'S OFFICE TO TROUBLESHOOT AND INITIALLY OBTAIN AN ERROR MESSAGE THAT THE HANDHELD WOULD NOT RECOGNIZE THE SOFTWARE HOWEVER, AFTER PERFORMING THREE HARD RESETS, THE VNS SOFTWARE LOADED. THE SCREEN CONTINUED TO FREEZE DURING INTERROGATION AND WOULD NOT PROGRESS FURTHER. THE ISSUE WAS ISOLATED TO THE HANDHELD AS WHEN THE COMPANY REP'S HANDHELD WAS USED WITH THE PHYSICIAN'S WAND, THERE WERE NO ISSUES HOWEVER, WHEN THE PHYSICIAN'S HANDHELD WAS USED WITH THE COMPANY REP'S WAND, THE ISSUE WOULD OCCUR. PER THE PHYSICIAN, THIS ISSUE BEGAN APPROX THREE WEEKS PRIOR TO THE REPORT TO THE MFR. A REPLACEMENT HANDHELD WAS SENT TO THE PHYSICIAN AND (B)(4) ATTEMPTS TO OBTAIN THE DELL X5 HANDHELD IN QUESTION ARE CURRENTLY BEING MADE.