MAUDE Adverse Event Report: NIHON KOHDEN CORPORATION MEB-9400A; ELECTROMYOGRAPH

Model Number	MEB-9400A
Medical Device Problem Codes	Use of Device Problem (1670); Device Operates Differently Than Expected (2913)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/09/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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.
Event or Problem Description
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.
Additional Manufacturer Narrative
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.

• Brand Name: MEB-9400A
• Common Device Name: ELECTROMYOGRAPH
• Manufacturer (Section D): NIHON KOHDEN CORPORATION; 1-31-4 nishiochia, shinjuku-ku; attn: shama mooman; tokyo, 161-8 560; JA 161-8560
• MDR Report Key: 7546759
• Report Number: 8030229-2018-00173
• Device Sequence Number: 11269950
• Product Code: IKN
• UDI-Device Identifier: 04931921102183
• UDI-Public: 04931921102183
• Combination Product (Y/N): N
• Initial Reporter State: LA
• Initial Reporter Country: US
• PMA/510(K) Number: K010590
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/25/2018
• Report Date (Section F): 05/25/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: MEB-9400A
• Device Catalogue Number: MEB-9400A
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 02/09/2018
• Device Age: 4 MO
• Event Location: Hospital
• Date Report to Manufacturer: 05/25/2018
• Initial Date Received by Manufacturer: 05/25/2018
• Supplement Date Received by Manufacturer: 05/25/2018
• Initial Report FDA Received Date: 05/25/2018
• Supplement Report FDA Received Date: 03/13/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Date Report Sent to FDA: 05/25/2018