CCU, MODULAR, IMAGE1 S CONNECT II, US

Additional Manufacturer Narrative

PER INVESTIGATION FINDINGS BY THE MANUFACTURING SITE: THE COMPLAINT ISSUE WAS DESCRIBED AS "NO IMAGE OR DASHBOARD". THE CUSTOMER'S COMPLAINT WAS VERIFIED. THE CUSTOMER RETURNED 4 UNITS FOR THE SAME NO IMAGE COMPLAINT 2X TC201US (SERIAL NUMBERS: (B)(6)). 2X TC304US (SERVICE ORDERS: (B)(4)). A FUNCTIONAL TEST CONFIRMED THE CUSTOMER'S COMPLAINT WAS ATTRIBUTED TO THEIR TC201US CAMERA CONTROL UNITS (CCUS). BOTH TC201US UNITS FAILED TO BOOT UP TO THE GUI: THE SCREEN WAS BLANK AND FANS WERE AT FULL SPEED. THE TC201US TOP COVERS WERE REMOVED, AND THE FOLLOWING WAS OBSERVED ON BOTH DEVICES: THE FPGA LEDS WERE OFF AND SO WAS THE MAX_CONFIG_DONEN LED. THIS INDICATES THAT THE CPLD WAS UNSUCCESSFUL IN LOADING THE FPGA CONFIGURATION FILES. ULTIMATELY, BOTH CUSTOMER'S TC201US MOTHERBOARDS WILL NEED TO BE REPLACED TO ADDRESS THE BOOTUP ISSUE. NO FUNCTIONAL ISSUES WERE ENCOUNTERED WITH EITHER TC304US CCU. THIS EVENT IS FILED UNDER INTERNAL COMPLAINT ID (B)(4). CROSS REFERENCE INTERNAL COMPLAINT ID (B)(4). CROSS REFERENCE INTERNAL COMPLAINT ID (B)(4). CROSS REFERENCE INTERNAL COMPLAINT ID (B)(4).

Description of Event or Problem

IT WAS REPORTED THAT WILL NOT PRODUCE ANY IMAGE OR DASHBOARD. THE ISSUE CAUSED A DELAY OF THE PROCEDURE. THE PROLONGATION WAS LONGER THAN 60 MINUTES. NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED. CROSS REFERENCE INTERNAL COMPLAINT ID (B)(4). CROSS REFERENCE INTERNAL COMPLAINT ID (B)(4). CROSS REFERENCE INTERNAL COMPLAINT ID (B)(4).

Additional Manufacturer Narrative

THE DEVICE WILL BE FORWARDED TO THE MANUFACTURING SITE FOR INVESTIGATION. 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). CROSS REFERENCE INTERNAL COMPLAINT ID (B)(4). CROSS REFERENCE INTERNAL COMPLAINT ID (B)(4). CROSS REFERENCE INTERNAL COMPLAINT ID (B)(4).