OR1 NEO IP, ENH2

Additional Manufacturer Narrative

THE DEVICE WILL NOT BE FORWARDED TO THE MANUFACTURING SITE FOR INVESTIGATION. RATHER, THEY WILL SEND A SERVICE TECH TO EVALUATE THE DEVICE IN THE FIELD. SHOULD RELEVANT ADDITIONAL INFORMATION / INVESTIGATION RESULTS BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED UNSOLICITED. THIS EVENT IS FILED UNDER INTERNAL COMPLAINT ID (B)(4).

Description of Event or Problem

IT WAS REPORTED THAT THE TOUCH PANEL IS ONLY DISPLAYIING THE MOUSE CURSOR, NO SOURCE OR DESTINATIONS, WITH AN ERROR MESSAGE OF "PROFILE NOT CONNECTING". THIS ISSUE HAPPENED PRIOR TO THE SCHEDULED PROCEDURE, NO PATIENT WAS INVOLVED. HOWEVER THE PROCEDURE HAD TO BE DELAYED. NO FURTHER INFORMATION WAS PROVIDED.

Additional Manufacturer Narrative

PER EVALUATION FINDINGS BY THE MANUFACTURING SITE: DESCRIPTION OF REPORTED ISSUE FROM THE END USER: UNIVERSAL POWER SOURCE (UPS) LED DISPLAY SHOWS BE & OR1 INTEGRATION SYSTEM ISN'T WORKING. ARE YOU ABLE TO REPRODUCE THE ISSUE AT WILL, OR IS IT INTERMITTENT? NO. POSSIBLE CAUSES (USE) PRIOR TO SYMPTOMS: UNKNOWN. BE ERROR CODE: BACK-FEED FAULT. HAS THE ISSUE BEEN RESOLVED? YES. IF YES, WHAT WAS THE RESOLUTION: INITIALLY POWER CYCLED UPS TO CLEAR ERROR TO GET UPS BACK UP AND RUNNING. FOR THE LONG RUN, REPLACEMENT OF UPS PERFORMED. THIS EVENT IS FILED UNDER INTERNAL COMPLAINT ID (B)(4).