BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MEB-9400A

    MDR report key: 7546759 · Received May 25, 2018

    Report

    Report Number
    8030229-2018-00173
    Event Type
    Malfunction
    Date Received
    May 25, 2018
    Date of Event
    February 9, 2018
    Report Date
    May 25, 2018
    Manufacturer
    NIHON KOHDEN CORPORATION
    Product Code
    IKN
    UDI-DI
    04931921102183
    PMA / PMN Number
    K010590
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THE DOCTOR REPORTED THAT THERE IS INACCURATE MARKING OF ONSET LATENCY WHEN TESTED ON SENSORY NERVES AND WHEN TESTED ON ALL MOTOR NERVES. THEY STATED THAT THIS HAS RESULTED IN AN INACCURATE DIAGNOSIS TO A PATIENT. WE HAVE ATTEMPTED TO CONTACT THE CUSTOMER TO INQUIRE ABOUT THE STATUS OF THE PATIENT, TO FURTHER TROUBLESHOOT, AND TO PROVIDE ADDITIONAL TRAINING ON THE USAGE OF THE DEVICE. THE CUSTOMER WAS INSTRUCTED TO CONTACT NKA, BUT THEY HAVE NOT RESPONDED BACK TO US. INVESTIGATION RESULT: THE ROOT CAUSE OF THE ISSUE LIST IS DUE TO USER ERROR/EDUCATION AND LACK OF RESPONSE. THE CUSTOMER HAD A REMOTE SESSION TO ADDRESS ISSUES ON THE LIST. THEY WERE ABLE TO GO THROUGH SOME OF THE LIST. THE MARKING ISSUES CLAIMED BY THE DOCTOR FOR INACCURACY AND MIS-DIAGNOSIS WERE NOT MENTIONED AS BEING REVIEWED DURING THE SESSION. TRIED MULTIPLE TIMES TO SET UP FOLLOW UP SESSION, BUT IT NEVER HAPPENED, THE DOCTOR WAS UNAVAILABLE. FINALLY, CUSTOMER REQUESTED THE SYSTEM BE RETURNED.

    Additional Manufacturer Narrative · 1

    THE DOCTOR REPORTED THAT THERE IS INACCURATE MARKING OF ONSET LATENCY WHEN TESTED ON SENSORY NERVES AND WHEN TESTED ON ALL MOTOR NERVES. THEY STATED THAT THIS HAS RESULTED IN AN INACCURATE DIAGNOSIS TO A PATIENT. WE HAVE ATTEMPTED TO CONTACT THE CUSTOMER TO INQUIRE ABOUT THE STATUS OF THE PATIENT, TO FURTHER TROUBLESHOOT, AND TO PROVIDE ADDITIONAL TRAINING ON THE USAGE OF THE DEVICE. THE CUSTOMER WAS INSTRUCTED TO CONTACT NKA, BUT THEY HAVE NOT RESPONDED BACK TO US. 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 DOCTOR REPORTED THAT THERE IS INACCURATE MARKING OF ONSET LATENCY WHEN TESTED ON SENSORY NERVES AND WHEN TESTED ON ALL MOTOR NERVES. THEY STATED THAT THIS HAS RESULTED IN AN INACCURATE DIAGNOSIS TO A PATIENT. WE HAVE ATTEMPTED TO CONTACT THE CUSTOMER TO INQUIRE ABOUT THE STATUS OF THE PATIENT TO FURTHER TROUBLESHOOT, AND TO PROVIDE ADDITIONAL TRAINING ON THE USAGE OF THE DEVICE. THE CUSTOMER WAS INSTRUCTED TO CONTACT NKA, BUT THEY HAVE NOT RESPONDED BACK TO US.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    386670 MEB-9400A ELECTROMYOGRAPH IKN NIHON KOHDEN CORPORATION MEB-9400A 04931921102183

    Patients

    Seq Age Sex Outcome Treatment
    1