IMAGE MANAGEMENT SYSTEM 660HD-E

Description of Event or Problem

IT WAS REPORTED THAT THE 660HD-E IMAGE MANAGEMENT SYSTEM HAD FOUND UNSATISFACTORY AS THE UNIT HAD AN ¿INTERMITTENT AUTO SHUTTING DOWN DURING SURGERY". 30 MINUTES DELAY AND A BACK UP WAS AVAILABLE TO COMPLETE THE PROCEDURE. NO PATIENT INJURY WAS REPORTED.

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 SHUTTING DOWN BY ITSELF COULD NOT BE REPRODUCED. UNIT PASSED FUNCTIONAL TESTING DURING 6 HOUR BURN-IN INCLUDING CAPTURE AND PRINT FUNCTION. UNIT DID NOT SHUT DOWN DURING BURN-IN. ALL VIDEO INPUTS/OUTPUTS NORMAL AND UNIT'S DISPLAY PERFORMED AS EXPECTED. BOTH ANALOG AND DIGITAL VIDEO OUTPUTS WERE TESTED DURING BURN-IN. 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.