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

Model Number	MEE-2000A
Medical Device Problem Codes	Application Program Problem (2880); Unintended Application Program Shut Down (4032)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/22/2022
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported that the unit is continuing to have power issues with the dc-200b main unit for the mee-2000a.This issue is intermittent, and the main unit will shut down randomly.The issue is not resolved and is still occurring.This is the third occurrence, and the other 2 have been reported in 300290922 and 300288051.The mee-2000a neural function measuring system is intended to monitor, record, and display the bioelectric signals produced by sensory and motor pathways; and the system measures and displays electric/ auditory/visual evoked potential (ep), electroencephalography (eeg), and electromyography (emg), skin temperature of distal portion of extremities, spo2, and etco2.The unit was not in patient use when the 3rd occurrence happened.
Additional Manufacturer Narrative
The customer reported that the unit is continuing to have power issues with the dc-200b main unit for the mee-2000a.This issue is intermittent, and the main unit will shut down randomly.The issue is not resolved and is still occurring.This is the third occurrence, and the other 2 have been reported in 300290922 and 300288051.The mee-2000a neural function measuring system is intended to monitor, record, and display the bioelectric signals produced by sensory and motor pathways; and the system measures and displays electric/ auditory/visual evoked potential (ep), electroencephalography (eeg), and electromyography (emg), skin temperature of distal portion of extremities, spo2, and etco2.The unit was not in patient use when the 3rd occurrence happened.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.Additional device information: the following device(s) were being used in conjunction with the mee-2000a.Main unit of the mee-2000a.Model: dc-200b.Sn: (b)(4).
Additional Manufacturer Narrative
Details of complaint: the customer reported that the mee-2000a system had continuously intermittent power issues with the dc-200b main unit, causing the main unit to shut down randomly.There have been 2 two other reports of the issue in tickets (b)(4) and (b)(4).The unit was not in patient use on the 3rd occurrence.No harm or injury was reported.Investigation summary: the cause of the shutdown was found to be a defective power cable for the main unit.As the cable was not returned for evaluation, a root cause cannot be determined.The mee system was delivered to the customer on 11/27/2019.As the mee is a portable system, a possible root cause of the defective power cable is physical damage due to wear and tear.This issue is deemed to be an isolated incident as the occurrences identified during complaint history review are for the same issue for the same serial number.No further issues have been reported.Additional device information: d10: concomitant medical device: the following device was being used in conjunction with the mee-2000a.Power cable: model: dc-200b sn: ni additional information: b4 date of this report d10 concomitant medical device g3 date received by manufacturer g6 type of report h2 if follow-up, what type? h6 event problem and evaluation codes h10 additional manufacturer narrative.
Event or Problem Description
The customer reported that the mee-2000a system had continuously intermittent power issues with the dc-200b main unit, causing the main unit to shut down randomly.There have been 2 two other reports of the issue in tickets (b)(4) and (b)(4).The unit was not in patient use on the 3rd occurrence.

• 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; seibu bldg 2, 4th floor 1-11-2; kusunokidai tokorozawa, saitama 359-8-580 ; JA 359-8580
• MDR Report Key: 14459294
• Report Number: 8030229-2022-02847
• Device Sequence Number: 4504483
• Product Code: GWF
• UDI-Device Identifier: 04931921118054
• UDI-Public: 04931921118054
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/12/2023

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: 04/22/2022
• Supplement Date Received by Manufacturer: 02/14/2023
• Initial Report FDA Received Date: 05/20/2022
• Supplement Report FDA Received Date: 06/12/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/20/2019
• 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
• Concomitant Medical Products and Therapy/Usage Dates: DC-200B; POWER CABLE: DC-200B
• Patient Sex: Unknown