BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VIVIDIMAGE 4K

    MDR report key: 19834278 · Received July 25, 2024

    Report

    Report Number
    3008776287-2024-00013
    Event Type
    Malfunction
    Date Received
    July 25, 2024
    Date of Event
    June 25, 2024
    Report Date
    July 25, 2024
    Manufacturer
    BLACK DIAMOND VIDEO, INC.
    Product Code
    KQM
    UDI-DI
    00724995195113
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DURING THE REPORTED EVENT, THE USER FACILITY WAS ABLE TO CLEAN UP THE BROKEN GLASS AND COVER THE MONITOR TO SUCCESSFULLY COMPLETE THE PROCEDURE. THIS CAUSED A MINOR TEN-MINUTE DELAY IN PROCEDURE. THE ROOT CAUSE OF THE REPORTED EVENT IS ATTRIBUTED TO THE USER FACILITY MISHANDLING THE SURGICAL LIGHT. THE TECHNICIAN REPAIRED THE NECESSARY COMPONENTS, TESTED THE MONITOR, FOUND IT TO BE OPERATING ACCORDING TO SPECIFICATION, AND RETURNED IT TO SERVICE. NO ADDITIONAL ISSUES HAVE BEEN REPORTED.

    Description of Event or Problem · 0

    THE USER FACILITY REPORTED THAT DURING A PATIENT PROCEDURE THEIR SURGICAL LIGHT MADE CONTACT WITH THE VIVIDIMAGE 4K DISPLAY CAUSING IT TO SHATTER. THERE WAS A MINOR DELAY IN PROCEDURE DUE TO THE REPORTED EVENT. NO REPORT OF INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    913857 VIVIDIMAGE 4K SURGICAL DISPLAY KQM BLACK DIAMOND VIDEO, INC. RLM314K3 00724995195113

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown