BEUDAMED
    FDA Adverse Event Summary report: N

    IDSS RGB CONVERTER

    MDR report key: 6153000 · Received December 7, 2016

    Report

    Report Number
    3008776287-2016-00001
    Date Received
    December 7, 2016
    Date of Event
    November 7, 2016
    Report Date
    December 7, 2016
    Manufacturer
    BLACK DIAMOND VIDEO
    Product Code
    FWC
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ME, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 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.

    Additional Manufacturer Narrative · 1

    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.

    Description of Event or Problem · 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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    801124 IDSS RGB CONVERTER RGB CONVERTER FWC BLACK DIAMOND VIDEO

    Patients

    Seq Age Sex Outcome Treatment
    1