SVC REPL 660HD-E IMAGE MANAGEMENT SYSTEM

Description of Event or Problem

IT WAS REPORTED THAT THE DEVICE HAD THE SCREEN BLACK. A BACKUP DEVICE WAS AVAILABLE TO COMPLETE THE PROCEDURE WITH NO DELAY OR PATIENT INJURIES.

Additional Manufacturer Narrative

THE DEVICE WAS RECEIVED FOR EVALUATION. THERE WAS NO RELATIONSHIP FOUND BETWEEN THE RETURNED DEVICE AND THE REPORTED INCIDENT. A VISUAL INSPECTION WAS PERFORMED ON THE PRODUCT AND NO ISSUE WAS OBSERVED. COMPLAINT OF BLANK DISPLAY COULD NOT BE REPRODUCED. UNIT PASSED FUNCTIONAL TESTING DURING 6 HOUR BURN-IN INCLUDING CAPTURE AND PRINT FUNCTION. UNIT DID NOT LOSE DISPLAY OR TOUCHSCREEN FUNCTION DURING BURN-IN. ALL VIDEO INPUTS/OUTPUTS NORMAL AND UNIT'S SOFTWARE PERFORMED AS EXPECTED. UNIT WAS TESTED IN BOTH PAL AND NTSC FORMATS AND BOTH ANALOG AND DIGITAL VIDEO OUTPUTS. THE COMPLAINT WAS NOT CONFIRMED AND THE ROOT CAUSE COULD NOT BE DETERMINED SINCE THE REPORTED MALFUNCTION COULD NOT BE DUPLICATED DURING THE PRODUCT EVALUATION PROCESS. A REVIEW OF THE DEVICE HISTORY RECORDS SHOWED THERE WERE NO INDICATIONS TO SUGGEST THAT THE PRODUCT DID NOT MEET MANUFACTURING SPECIFICATION OR WOULD NOT BE ABLE TO PERFORM AS INTENDED.