SVC REPL 660HD-E IMAGE MANAGEMENT SYSTEM

Additional Manufacturer Narrative

H10: INTERNAL COMPLAINT REFERENCE (B)(4). H3, H6: THE REPORTED DEVICE WAS RECEIVED FOR EVALUATION. A VISUAL INSPECTION REVEALED NO DEFICIENCIES. A FUNCTIONAL EVALUATION WAS PERFORMED ON THE RETURNED DEVICE AND FOUND THE FAN WAS FUNCTIONAL. THE UNIT WAS LEFT RUNNING FOR APPROXIMATELY 20 MINUTES AND NO OVERHEATING OR SMOKE WAS OBSERVED. NO FUNCTIONAL ISSUES WERE FOUND. THE CASE WAS REMOVED AND THE INTERNAL COMPONENTS WERE INSPECTED REVEALING MULTIPLE BURNT CAPACITORS ON THE VOLTAGE REGULATOR PCB. THESE FINDINGS ARE RELATED TO THE REPORTED EVENT. A REVIEW OF DEVICE RECORDS SHOWED THERE WERE NO INDICATIONS TO SUGGEST THAT THE PRODUCT DID NOT MEET MANUFACTURING SPECIFICATIONS UPON RELEASE FOR DISTRIBUTION. A COMPLAINT HISTORY REVIEW FOUND NO 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 A COMPONENT FAILURE. FACTORS THAT COULD HAVE CONTRIBUTED TO THE FAILURE INCLUDE ELECTRICAL SURGES, AND OR A WEAK COMPONENT. NO CONTAINMENT OR CORRECTIVE ACTIONS ARE RECOMMENDED AT THIS TIME.

Description of Event or Problem

IT WAS REPORTED THAT DURING SET UP, THE IMAGE MANAGEMENT SYSTEM UNIT STARTED TO SMOKE WHEN TURNED ON. THERE WAS A SMITH AND NEPHEW BACK UP DEVICE AVAILABLE AND NO SURGICAL DELAY WAS REPORTED. THERE WAS NO PATIENT INVOLVEMENT.

Additional Manufacturer Narrative

H10: INTERNAL COMPLAINT REFERENCE: (B)(4).