BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEUROFAX

    MDR report key: 19282102 · Received May 9, 2024

    Report

    Report Number
    8030229-2024-04287
    Event Type
    Malfunction
    Date Received
    May 9, 2024
    Date of Event
    April 9, 2024
    Report Date
    January 23, 2025
    Manufacturer
    NIHON KOHDEN CORPORATION
    Product Code
    OLT
    UDI-DI
    04931921110904
    PMA / PMN Number
    K080546
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DETAILS OF THE COMPLAINT: THE CUSTOMER REPORTED THAT THE EXAMS LISTED HAVE INCORRECT MEDICAL RECORD NUMBERS. THEY CAN EDIT THE MEDICAL RECORDS NUMBER, AND IT CHANGES, AND THEN IN 24 HOURS IT CHANGES BACK. IT APPEARS THAT WHEN YOU CLICK TO CHECK FOR ACCURACY THE CUSTOMER DOES NOT HAVE RIGHTS TO THE FOLDER TO MAKE THE CHANGES. NOT IN PATIENT USE. INVESTIGATION CONCLUSION: THE NIHON KOHDEN NEUROLOGY ENGINEERING SERVICE TEAM (NK NES) CHECKED THE CUSTOMER DATABASE AND FOUND THAT A DATABASE REGISTRATION FILE WAS RECREATED AND NOT GETTING DELETED NORMALLY AS PART OF THE SUB TO MAIN DATABASE PROCESS WHENEVER NEUROWORKBENCH (NWB) WAS LAUNCHED. NK NES USED AN INSTALLATION TOOL TO KEEP THE EXTRA FILE FROM BEING CREATED AS A WORKAROUND SOLUTION. A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED FROM NK NES' REVIEW OF THE CUSTOMER DATABASE, BUT A TEMPORARY SOLUTION WAS CREATED FOR THE CUSTOMER. POSSIBLE CAUSE MAY BE A SOFTWARE DEFICIENCY WITH THE DATABASE MANAGEMENT TOOLS USED WITH NWB. A REVIEW OF THE CUSTOMER'S COMPLAINT HISTORY DOES NOT SHOW RECURRENCE OR OTHER SIMILAR COMPLAINTS. THE FOLLOWING FIELDS CONTAINS NO INFORMATION (NI), AS ATTEMPTS TO OBTAIN INFORMATION WERE MADE, BUT THE INFORMATION WAS NOT PROVIDED. D4 SERIAL NUMBER H4 DEVICE MANUFACTURER DATE ATTEMPT #1: (B)(6) 2024 EMAILED CUSTOMER VIA MICROSOFT OUTLOOK FOR ALL ITEMS UNDER THE NO INFORMATION SECTION. NO REPLY WAS RECEIVED. ATTEMPT #2 (B)(6) 2024 EMAILED CUSTOMER VIA MICROSOFT OUTLOOK FOR ALL ITEMS UNDER THE NO INFORMATION SECTION. THE CUSTOMER RESPONDED BACK WITH COMPLAINT DETAILS, BUT THEY DID NOT PROVIDE THE PATIENT AND DEVICE INFORMATION AS REQUESTED. EEG REVIEW UNIT. MODEL: EEG-1200 REVIEW UNIT SN: NA. CORRECTED INFORMATION: D1 BRAND NAME WAS CORRECTED FROM EEG-1200A TO NEUROFAX

    Additional Manufacturer Narrative · 0

    DETAILS OF THE COMPLAINT: THE CUSTOMER REPORTED THAT THE EXAMS LISTED HAVE INCORRECT MEDICAL RECORD NUMBERS. THEY CAN EDIT THE MEDICAL RECORDS NUMBER, AND IT CHANGES, AND THEN IN 24 HOURS IT CHANGES BACK. IT APPEARS THAT WHEN YOU CLICK TO CHECK FOR ACCURACY THE CUSTOMER DOES NOT HAVE RIGHTS TO THE FOLDER TO MAKE THE CHANGES. NOT IN PATIENT USE. INVESTIGATION CONCLUSION: THE NIHON KOHDEN NEUROLOGY ENGINEERING SERVICE TEAM (NK NES) CHECKED THE CUSTOMER DATABASE AND FOUND THAT A DATABASE REGISTRATION FILE WAS RECREATED AND NOT GETTING DELETED NORMALLY AS PART OF THE SUB TO MAIN DATABASE PROCESS WHENEVER NEUROWORKBENCH (NWB) WAS LAUNCHED. NK NES USED AN INSTALLATION TOOL TO KEEP THE EXTRA FILE FROM BEING CREATED AS A WORKAROUND SOLUTION. A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED FROM NK NES' REVIEW OF THE CUSTOMER DATABASE, BUT A TEMPORARY SOLUTION WAS CREATED FOR THE CUSTOMER. POSSIBLE CAUSE MAY BE A SOFTWARE DEFICIENCY WITH THE DATABASE MANAGEMENT TOOLS USED WITH NWB. A REVIEW OF THE CUSTOMER'S COMPLAINT HISTORY DOES NOT SHOW RECURRENCE OR OTHER SIMILAR COMPLAINTS. THE FOLLOWING FIELDS CONTAINS NO INFORMATION (NI), AS ATTEMPTS TO OBTAIN INFORMATION WERE MADE, BUT THE INFORMATION WAS NOT PROVIDED. D4 SERIAL NUMBER. H4 DEVICE MANUFACTURER DATE. ATTEMPT #1: (B)(6) 2024 EMAILED CUSTOMER VIA MICROSOFT OUTLOOK FOR ALL ITEMS UNDER THE NO INFORMATION SECTION. NO REPLY WAS RECEIVED. ATTEMPT #2: (B)(6) 2024 EMAILED CUSTOMER VIA MICROSOFT OUTLOOK FOR ALL ITEMS UNDER THE NO INFORMATION SECTION. THE CUSTOMER RESPONDED BACK WITH COMPLAINT DETAILS, BUT THEY DID NOT PROVIDE THE PATIENT AND DEVICE INFORMATION AS REQUESTED. EEG REVIEW UNIT: MODEL: EEG-1200 REVIEW UNIT: SN: NA. CORRECTED INFORMATION: D1 BRAND NAME WAS CORRECTED FROM EEG-1200A TO NEUROFAX D4 UNIQUE IDENTIFIER (UDI) CORRECTED FROM (B)(4).

    Additional Manufacturer Narrative · 0

    THE CUSTOMER REPORTED THAT THE EXAMS LISTED HAVE INCORRECT MEDICAL RECORD NUMBERS. THEY CAN EDIT THE MEDICAL RECORDS NUMBER, AND IT CHANGES, AND THEN IN 24 HOURS IT CHANGES BACK. IT APPEARS THAT WHEN YOU CLICK TO CHECK FOR ACCURACY THE CUSTOMER DOES NOT HAVE RIGHTS TO THE FOLDER TO MAKE THE CHANGES. NOT IN PATIENT USE. NIHON KOHDEN CONTINUES TO INVESTIGATE THE REPORTED EVENT. NIHON KOHDEN WILL SUBMIT A SUPPLEMENTAL REPORT IN ACCORDANCE WITH 21 CFR SECTION 803.56 WHEN ADDITIONAL INFORMATION BECOMES AVAILABLE. THE FOLLOWING FIELDS CONTAINS NO INFORMATION (NI), AS ATTEMPTS TO OBTAIN INFORMATION WERE MADE, BUT THE INFORMATION WAS NOT PROVIDED. D4 SERIAL NUMBER H4 DEVICE MANUFACTURER DATE ATTEMPT #1 (B)(6)/2024 EMAILED CUSTOMER VIA MICROSOFT OUTLOOK FOR ALL ITEMS UNDER THE NO INFORMATION SECTION. NO REPLY WAS RECEIVED. ATTEMPT #2 (B)(6)2024 EMAILED CUSTOMER VIA MICROSOFT OUTLOOK FOR ALL ITEMS UNDER THE NO INFORMATION SECTION. THE CUSTOMER RESPONDED BACK WITH COMPLAINT DETAILS, BUT THEY DID NOT PROVIDE THE PATIENT AND DEVICE INFORMATION AS REQUESTED. EEG REVIEW UNIT MODEL: EEG-1200 REVIEW UNIT SN: NA.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED THAT THE EXAMS LISTED HAVE INCORRECT MEDICAL RECORD NUMBERS. THEY CAN EDIT THE MEDICAL RECORDS NUMBER, AND IT CHANGES, AND THEN IN 24 HOURS IT CHANGES BACK. IT APPEARS THAT WHEN YOU CLICK TO CHECK FOR ACCURACY THE CUSTOMER DOES NOT HAVE RIGHTS TO THE FOLDER TO MAKE THE CHANGES. NOT IN PATIENT USE.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED THAT THE EXAMS LISTED HAVE INCORRECT MEDICAL RECORD NUMBERS. THEY CAN EDIT THE MEDICAL RECORDS NUMBER, AND IT CHANGES, AND THEN IN 24 HOURS IT CHANGES BACK. IT APPEARS THAT WHEN YOU CLICK TO CHECK FOR ACCURACY THE CUSTOMER DOES NOT HAVE RIGHTS TO THE FOLDER TO MAKE THE CHANGES. NOT IN PATIENT USE.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED THAT THE EXAMS LISTED HAVE INCORRECT MEDICAL RECORD NUMBERS. THEY CAN EDIT THE MEDICAL RECORDS NUMBER, AND IT CHANGES, AND THEN IN 24 HOURS IT CHANGES BACK. IT APPEARS THAT WHEN YOU CLICK TO CHECK FOR ACCURACY THE CUSTOMER DOES NOT HAVE RIGHTS TO THE FOLDER TO MAKE THE CHANGES. NOT IN PATIENT USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    483582 NEUROFAX ELECTROENCEPHALOGRAPH OLT NIHON KOHDEN CORPORATION EEG-1200A NA 04931921110904

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown EEG REVIEW UNIT| EEG REVIEW UNIT| EEG REVIEW UNIT