IMAGE MANAGEMENT SYSTEM 660HD-E

Additional Manufacturer Narrative

H10 H3, H6: THE REPORTED DEVICE WAS RECEIVED FOR EVALUATION. A VISUAL INSPECTION WAS PERFORMED ON THE EXTERIOR OF THE DEVICE AND NO DEFICIENCIES WERE OBSERVED. A FUNCTIONAL EVALUATION WAS PERFORMED ON THE RETURNED DEVICE AND FOUND THAT THE DEVICE FAILED TO BOOTUP. IT PRESENTED "YOUR PC DID NOT START CORRECTLY-PRESS RESTART TO RESTART PC" ERROR MESSAGE WITH A BLUE SCREEN. A REVIEW OF DEVICE RECORDS SHOWED THERE WERE NO INDICATIONS TO SUGGEST THAT THE PRODUCT DID NOT MEET MANUFACTURING SPECIFICATION UPON RELEASE FOR DISTRIBUTION. A COMPLAINT HISTORY REVIEW FOUND SIMILAR REPORTED EVENTS. A RISK MANAGEMENT REVIEW FOUND THAT THE REPORTED FAILURE AND/OR HARM WAS DOCUMENTED APPROPRIATELY, AND THERE WERE NO INDICATIONS TO SUGGEST THE ANTICIPATED RISK IS NOT ADEQUATE. THE ROOT CAUSE HAS BEEN ASSOCIATED WITH COMPONENT FAILURE. FACTORS THAT COULD HAVE CONTRIBUTED TO THE FAILURE INCLUDE A HARDWARE DEVICE, ITS DRIVER, OR RELATED SOFTWARE. BASED ON THIS INVESTIGATION, THE NEED FOR CORRECTIVE ACTION IS NOT INDICATED.

Additional Manufacturer Narrative

H11: INTERNAL COMPLAINT REFERENCE(B)(4).

Description of Event or Problem

IT WAS REPORTED THAT DURING A PROCEDURE, DURING THE IMAGE MANAGEMENT SYSTEM 660 HD-E STARTUP PROCESS, A SOFTWARE ISSUE OCCURRED, DISPLAYING AN "AUTOMATIC REPAIR" BLUE SCREEN. THE PROCEDURE WAS COMPLETED AFTER A SIGNIFICANT SURGICAL DELAY GREATER THAN 30MIN USING A BACK-UP DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.