BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CNS-6801A

    MDR report key: 11612100 · Received April 4, 2021

    Report

    Report Number
    2080783-2021-00192
    Event Type
    Malfunction
    Date Received
    April 4, 2021
    Date of Event
    March 5, 2021
    Report Date
    April 4, 2021
    Manufacturer
    NIHON KOHDEN CORPORATION
    Product Code
    MHX
    UDI-DI
    04931921131640
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    VA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    NIHON KOHDEN CLINICAL APPLICATION SPECIALIST REPORTED THAT THERE WAS NO SOUND COMING FROM THE CNS. THEY STATED THAT THE SETTINGS IN THE SOUND CONTROL TAB WERE CORRECT AS WELL AS THE SOUND SYNC SETTINGS, BUT FOR SOME UNKNOWN REASON NO SOUND IS COMING FROM THE DEVICE. NIHON KOHDEN TECHNICAL SUPPORT (TECH SUPPORT) ASKED THEM TO EXIT THE CNS APPLICATION. ONCE IT WAS CLOSED, TECH SUPPORT ASKED THEM TO PLEASE CLICK ON THE WINDOWS ICON ON THE LOWER LEFT HAND CORNER OF THE MONITOR. WHEN ASKED IF SHE COULD SELECT SOUND, THEY INFORMED TECH SUPPORT THAT THE OPTION WAS NOT PRESENT. THEY WERE THEN ABLE TO OPEN THE SOUND SETTINGS BY SEARCHING FOR SOUND IN THE WINDOWS SEARCH BAR. TECH SUPPORT THEN ASKED WHAT WAS LISTED AS THE OUTPUT DEVICE. THEY STATED THAT REALTEK AUDIO WAS THE ONLY OPTION AVAILABLE, SO TECH SUPPORT THEN ASKED THEM TO REMOVE THE AUDIO CABLE AND THEN PLUGGED IT BACK IN. ONCE THIS WAS DONE, THEY STATED THAT SOUND WAS NOW COMING FROM THE DEVICE. NO PATIENT HARM WAS REPORTED.

    Description of Event or Problem · 1

    NIHON KOHDEN CLINICAL APPLICATION SPECIALIST REPORTED THAT THERE WAS NO SOUND COMING FROM THE CNS. THEY STATED THAT THE SETTINGS IN THE SOUND CONTROL TAB WERE CORRECT AS WELL AS THE SOUND SYNC SETTINGS, BUT FOR SOME UNKNOWN REASON NO SOUND IS COMING FROM THE DEVICE. NIHON KOHDEN TECHNICAL SUPPORT (TECH SUPPORT) ASKED THEM TO EXIT THE CNS APPLICATION. ONCE IT WAS CLOSED, TECH SUPPORT ASKED THEM TO PLEASE CLICK ON THE WINDOWS ICON ON THE LOWER LEFT HAND CORNER OF THE MONITOR. WHEN ASKED IF SHE COULD SELECT SOUND, THEY INFORMED TECH SUPPORT THAT THE OPTION WAS NOT PRESENT. THEY WERE THEN ABLE TO OPEN THE SOUND SETTINGS BY SEARCHING FOR SOUND IN THE WINDOWS SEARCH BAR. TECH SUPPORT THEN ASKED WHAT WAS LISTED AS THE OUTPUT DEVICE. THEY STATED THAT REALTEK AUDIO WAS THE ONLY OPTION AVAILABLE, SO TECH SUPPORT THEN ASKED THEM TO REMOVE THE AUDIO CABLE AND THEN PLUGGED IT BACK IN. ONCE THIS WAS DONE, THEY STATED THAT SOUND WAS NOW COMING FROM THE DEVICE. NO PATIENT HARM WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    509164 CNS-6801A CENTRAL MONITOR SYSTEM MHX NIHON KOHDEN CORPORATION CNS-6801A NA 04931921131640

    Patients

    Seq Age Sex Outcome Treatment
    1