USER FACILITY PERSONNEL STATED THAT THE MONITOR WAS DISPLAYING A GREEN SCALE INSTEAD OF THE GREY SCALE. THE GREY SCALE IS A BLACK AND WHITE IMAGE AND THE GREEN SCALE IS A GREEN AND WHITE IMAGE. THE GREEN AND WHITE IMAGE OCCURRED DURING THE REPORTED EVENT. A (B)(4) SERVICE TECHNICIAN ARRIVED ONSITE TO INSPECT THE EQUIPMENT. DURING THE TECHNICIAN'S INSPECTION, HE FOUND THAT THE RGB CONVERTER WAS NOT OPERATING PROPERLY. THE FUNCTION OF THE RGB CONVERTER IS TO TAKE AN ANALOG RGB VIDEO SIGNAL AND CONVERT IT INTO A DVI SIGNAL THAT IS COMPATIBLE WITH THE STERIS (B)(4) IDSS SYSTEM. DURING THE REPORTED EVENT, THE RGB CONVERTER TAKES THE VIDEO SIGNAL FROM THE GE FLUOROSCOPE AND CONVERTS IT INTO THE DVI SIGNAL. IT IS ALSO CONFIGURED TO TELL THE IDSS SYSTEM TO TREAT THE SIGNAL AS A GREY SCALE. THE RGB CONVERTER IS A STERIS (B)(4) PRODUCT AND IS SERVICED AND MAINTAINED BY STERIS (B)(4). THE INVESTIGATION OF THIS EVENT IS CURRENTLY IN PROCESS. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN ADDITIONAL INFORMATION BECOMES AVAILABLE.
D
Patient 1
THE USER FACILITY REPORTED THAT DURING A PATIENT PROCEDURE THE IMAGE ON THE MONITOR TURNED FROM GREY TO GREEN. USER FACILITY PERSONNEL CONTINUED TO USE THE MONITOR AS THE IMAGE WAS STILL PROJECTED AND THE PATIENT PROCEDURE WAS COMPLETED SUCCESSFULLY.
N
Patient 1
THE IDDS PRODUCT INCLUDES A HIGH RESOLUTION SURGICAL DISPLAY. THE USER FACILITY REPORTED THAT THE DISPLAY'S GREY SCALE IMAGE CHANGED TO GREEN SCALE DURING A PATIENT PROCEDURE. THE USER FACILITY SUCCESSFULLY COMPLETED THE PROCEDURE; NO INJURIES OR DELAYS OCCURRED AS A RESULT OF THE REPORTED EVENT. A SERVICE TECHNICIAN INSPECTED THE IDDS EQUIPMENT AND DETERMINED THE RGB CONVERTER AND POWER SUPPLY REQUIRED REPLACEMENT. THE TECHNICIAN REPLACED THE COMPONENTS, INSPECTED AND CLEANED THE EQUIPMENT CONNECTIONS, AND RETURNED THE IDDS TO SERVICE. NO ADDITIONAL ISSUES HAVE BEEN REPORTED.