BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MEB-9400A

    MDR report key: 8144261 · Received December 7, 2018

    Report

    Report Number
    8030229-2018-00463
    Event Type
    Malfunction
    Date Received
    December 7, 2018
    Date of Event
    November 9, 2018
    Report Date
    December 7, 2018
    Manufacturer
    NIHON KOHDEN CORPORATION
    Product Code
    IKN
    UDI-DI
    04931921102183
    PMA / PMN Number
    K010590
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: F7. TYPE OF REPORT? G7. TYPE OF REPORT H2. IF FOLLOW-UP, WHAT TYPE? H10. ADDITIONAL MANUFACTURE NARRATIVE. CORRECT DATA: H10. ADDITIONAL MANUFACTURE NARRATIVE: DETAILS OF COMPLAINT: GETTING DUPLICATE FILES GENERATED WHEN PERFORMING NCS AND EMG TESTS. CUSTOMER REPORTS THAT THEY ARE GETTING DUPLICATE FILES GENERATED WHEN PERFORMING NCS AND EMG TESTS. NKA REMOTED INTO THE SYSTEM AND SAW THE PROBLEM. CUSTOMER REPORTS THAT THEY ARE HAVING THIS ISSUE INTERMITTENTLY. THIS APPEARS TO BE HAPPENING MAINLY WITH NCS TESTS AND NOT EMG'S. TODAY, THEY HAD SOME FILES FROM ONE PATIENT SAVED INTO ANOTHER PATIENT'S NWB PATIENT NODE AND THEY HAD GENERATED A REPORT FOR THIS PATIENT'S EXAMS WITH THE CORRECT DATA BEFORE FINALIZING THE DATA AND WE WERE ABLE TO SEPARATE THOSE FILES OUT AND PLACE THEM UNDER THE CORRECT PATIENT NODE AND GENERATE A NEW REPORT. SERVICE REQUESTED: TROUBLESHOOTING. SERVICE PERFORMED: TROUBLESHOOTING. INVESTIGATION RESULT: THE CUSTOMER REPORTED THAT THE EMG (ELECTROMYOGRAPHY) DATA RECORDED UNDER ANOTHER PATIENT'S NODE. WE CONTACTED TO THE CUSTOMER TO VERIFY IF THIS WAS DONE IN USER ERROR WHERE AN INCORRECT PATIENT NAME WAS CHOSEN WHEN THE STUDY WAS STARTED. HOWEVER, THE CUSTOMER WAS NOT SURE HOW IT HAPPENED AND STATED THAT THIS WAS A SINGLE-TIME OCCURRENCE. WE DID ASK TO LOOK INTO THEIR DEVICE REMOTELY TO COLLECT INFORMATION, BUT THEY REFUSED TO DO THAT. NO PATIENT HARM OR INJURY REPORTED.

    Additional Manufacturer Narrative · 1

    THE CUSTOMER REPORTED THAT THE EMG (ELECTROMYOGRAPHY) DATA RECORDED UNDER ANOTHER PATIENT'S NODE. WE CONTACTED TO THE CUSTOMER TO VERIFY IF THIS WAS DONE IN USER ERROR WHERE AN INCORRECT PATIENT NAME WAS CHOSEN WHEN THE STUDY WAS STARTED. HOWEVER, THE CUSTOMER WAS NOT SURE HOW IT HAPPENED AND STATED THAT THIS WAS A SINGLE-TIME OCCURRENCE. WE DID ASK TO LOOK INTO THEIR DEVICE REMOTELY TO COLLECT INFORMATION BUT THEY REFUSED TO DO THAT. NO PATIENT HARM OR INJURY REPORTED. NIHON KOHDEN CONTINUES TO INVESTIGATE THE REPORTED EVENT. NIHON KOHDEN WILL SUBMIT A SUPPLEMENTAL REPORT IN ACCORDANCE WITH 21 CFR SECTION 803.56 IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE EMG (ELECTROMYOGRAPHY) DATA RECORDED UNDER ANOTHER PATIENT'S NODE. WE CONTACTED TO THE CUSTOMER TO VERIFY IF THIS WAS DONE IN USER ERROR WHERE AN INCORRECT PATIENT NAME WAS CHOSEN WHEN THE STUDY WAS STARTED. HOWEVER, THE CUSTOMER WAS NOT SURE HOW IT HAPPENED AND STATED THAT THIS WAS A SINGLE-TIME OCCURRENCE. WE DID ASK TO LOOK INTO THEIR DEVICE REMOTELY TO COLLECT INFORMATION BUT THEY REFUSED TO DO THAT. NO PATIENT HARM OR INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    981427 MEB-9400A ELECTROMYOGRAPH IKN NIHON KOHDEN CORPORATION MEB-9400A 04931921102183

    Patients

    Seq Age Sex Outcome Treatment
    1