MAUDE Adverse Event Report: NIHON KOHDEN CORPORATION MEE-2000A; EVOKED RESPONSE ELECTRIC STIMULATOR

Model Number	MEE-2000A
Medical Device Problem Code	Communication or Transmission Problem (2896)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/04/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The customer reported that emg was triggered, indicating that the reported current is not accurate under 2ma and differs from the actual current provided.It is unknown whether the unit was in patient use at the time.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.
Event or Problem Description
The customer reported that emg was triggered, indicating that the reported current is not accurate under 2ma and differs from the actual current provided.It is unknown whether the unit was in patient use at the time.
Additional Manufacturer Narrative
Details of complaint: the customer reported that emg was triggered, indicating that the reported current is not accurate under 2ma and differs from the actual current provided.It is unknow whether the unit was in patient use at the time.Investigation summary: the dc-200ba, a component of the mee-2000a underwent a design change in 2017 to improve an emc quality measure.The reported issue occurs on the dc-200ba with serial numbers (b)(6) and later to which this design change was applied.Comparing the operation of the dc-200ba before and after this design change, it was confirmed that there was a difference in the output current measurement when the output was open and electrical stimulation was performed at 2ma or less.Additional information: b4 date of this report g3 date received by manufacturer g6 type of report h2 if follow up, what type? h11 additional manufacturer narrative manufacturer references # 300351856-196436 follow up 001.
Event or Problem Description
The customer reported that emg was triggered, indicating that the reported current is not accurate under 2ma and differs from the actual current provided.It is unknow whether the unit was in patient use at the time.

• Brand Name: MEE-2000A
• Common Device Name: EVOKED RESPONSE ELECTRIC STIMULATOR
• Manufacturer (Section D): NIHON KOHDEN CORPORATION; attn: shama mooman; 1-31-4 nishiochia; shinjuku-ku, tokyo 161-8 560; JA 161-8560
• Manufacturer (Section G): NIHON KOHDEN TOMIOKA CORPORATION; attn: shama mooman; 1-1 tajino; tomioka city, gunma 370-2 314; JA 370-2314
• Manufacturer Contact: shama mooman ; seibu bldg 2, 4th floor 1-11-2; kusunokidai tokorozawa, saitama 359-8-580 ; JA 359-8580
• MDR Report Key: 18432381
• Report Number: 8030229-2024-03994
• Device Sequence Number: 7661015
• Product Code: GWF
• UDI-Device Identifier: 04931921118054
• UDI-Public: 04931921118054
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: K142624
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date (Section B): 06/18/2024

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: MEE-2000A
• Device Catalogue Number: MEE-2000A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/04/2023
• Supplement Date Received by Manufacturer: 06/17/2024
• Initial Report FDA Received Date: 01/02/2024
• Supplement Report FDA Received Date: 06/18/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown