BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEXAVUE INTEGRATION SYSTEM

    MDR report key: 13053602 · Received December 21, 2021

    Report

    Report Number
    3008776287-2021-00005
    Event Type
    Malfunction
    Date Received
    December 21, 2021
    Date of Event
    November 17, 2021
    Report Date
    December 21, 2021
    Manufacturer
    BLACK DIAMOND VIDEO
    Product Code
    KQM
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    A DEVICE TECHNOLOGIES AUSTRALIA TECHNICIAN ARRIVED ONSITE TO INSPECT THE HEXAVUE INTEGRATION SYSTEM AND WAS ABLE TO DUPLICATE THE REPORTED EVENT WHILE USING THE 4K EXTRON SCALER. UPON TROUBLESHOOTING WITH STERIS AND THE SUPPLIER OF THE SCALER, IT WAS IDENTIFIED THAT THE FIRMWARE ON THE SCALER REQUIRED UPDATING. TO RESOLVE THE ISSUE, THE TECHNICIAN UPDATED THE FIRMWARE, TESTED THE SYSTEM, CONFIRMED IT TO BE OPERATING ACCORDING TO SPECIFICATIONS, AND RETURNED IT TO SERVICE. A REVIEW OF COMPLAINTS INDICATES THIS TO BE AN ISOLATED EVENT. NO ADDITIONAL ISSUES HAVE BEEN REPORTED.

    Additional Manufacturer Narrative · 0

    STERIS HAS CONTACTED OUR DEALER, (B)(4), TO OBTAIN ADDITIONAL INFORMATION REGARDING THE REPORTED EVENT. OUR INVESTIGATION IS IN PROCESS. A FOLLOW-UP MDR WILL BE SUBMITTED WHEN ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 0

    THE USER FACILITY REPORTED THAT DURING A PATIENT PROCEDURE THAT HALF OF THE SCREEN OF THE VIDEO WAS BLANK WHILE USING THEIR HEXAVUE INTEGRATION SYSTEM. THE PROCEDURE WAS COMPLETED. NO REPORT OF INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1952972 HEXAVUE INTEGRATION SYSTEM INTEGRATION SYSTEM KQM BLACK DIAMOND VIDEO

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown