BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NI

    MDR report key: 11356071 · Received February 20, 2021

    Report

    Report Number
    2080783-2021-00094
    Event Type
    Malfunction
    Date Received
    February 20, 2021
    Date of Event
    January 22, 2021
    Report Date
    February 20, 2021
    Manufacturer
    NIHON KOHDEN CORPORATION
    Product Code
    OLT
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE DOCTOR REPORTED THAT A PATIENT WAS SEIZING AND THAT THEY WERE UNABLE TO REMOTE INTO THE ACQUISITION EEG UNIT TO VIEW THE EEG IN PROGRESS. THEY WERE USING A RDP (REMOTE DESKTOP PROTOCOL) INTO A REVIEW STATION THAT IS 20 MILES FROM THEIR HOME. BY CONNECTING TO A REVIEW STATION, THE USER CAN THEN CONNECT TO THE ACQUISITION EEG THAT IS CONNECTED TO THE PATIENT AND DOING THE PHYSICAL EEG MONITORING ON THE PATIENT. NIHON KOHDEN TECHNICAL SUPPORT (TECH SUPPORT) WAS ABLE TO REMOTE INTO THE DOCTOR'S MACHINE AND OBSERVE THE ISSUE. NWB (NUEROWORKBENCH) WAS NOT CONNECTED TO THE DATABASE. TECH SUPPORT OPENED SERVICES AND BOTH SQL SERVICES WERE NOT RUNNING. TECH SUPPORT STARTED THE SERVICES AND RELAUNCHED NWB; AND THE ISSUE WAS RESOLVED. THE CUSTOMER WOULD NOT LET TECH SUPPORT FURTHER TROUBLESHOOT TO SEE WHAT COULD HAVE POSSIBLY HAPPENED TO TURNED OFF THE SQL. ATTEMPT #1: 02/01/2021- EMAILED CUSTOMER VIA MICROSOFT OUTLOOK FOR ALL ITEMS UNDER THE NO INFORMATION SECTION. NO REPLY WAS RECEIVED. ATTEMPT #2: 02/18/2021 - EMAILED CUSTOMER VIA MICROSOFT OUTLOOK FOR ALL ITEMS UNDER THE NO INFORMATION SECTION. NO REPLY WAS RECEIVED. ATTEMPT #3: 02/19/2021 - EMAILED CUSTOMER VIA MICROSOFT OUTLOOK FOR ALL ITEMS UNDER THE NO INFORMATION SECTION. THE CUSTOMER REPLIED BACK WITH OTHER ISSUES AND DID NOT PROVIDE PATIENT OR ADDITIONAL DEVICE INFORMATION. ADDITIONAL DEVICE INFORMATION: CONCOMITANT MEDICAL DEVICE FIELD CONTAINS NO INFORMATION (NI), AS ATTEMPTS TO OBTAIN INFORMATION WERE MADE, BUT NOT PROVIDED.

    Description of Event or Problem · 1

    THE DOCTOR REPORTED THAT A PATIENT WAS SEIZING AND THAT THEY WERE UNABLE TO REMOTE INTO THE ACQUISITION EEG UNIT TO VIEW THE EEG IN PROGRESS. THEY WERE USING A RDP (REMOTE DESKTOP PROTOCOL) INTO A REVIEW STATION THAT IS 20 MILES FROM THEIR HOME. BY CONNECTING TO A REVIEW STATION, THE USER CAN THEN CONNECT TO THE ACQUISITION EEG THAT IS CONNECTED TO THE PATIENT AND DOING THE PHYSICAL EEG MONITORING ON THE PATIENT. NIHON KOHDEN TECHNICAL SUPPORT (TECH SUPPORT) WAS ABLE TO REMOTE INTO THE DOCTOR'S MACHINE AND OBSERVE THE ISSUE. NWB (NUEROWORKBENCH) WAS NOT CONNECTED TO THE DATABASE. TECH SUPPORT OPENED SERVICES AND BOTH SQL SERVICES WERE NOT RUNNING. TECH SUPPORT STARTED THE SERVICES AND RELAUNCHED NWB; AND THE ISSUE WAS RESOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    252835 NI NEUROFAX ELECTROENCEPHALOGRAPH OLT NIHON KOHDEN CORPORATION NI NA

    Patients

    Seq Age Sex Outcome Treatment
    1