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

Model Number	MEE-2000A
Medical Device Problem Codes	Energy Output Problem (1431); Output Problem (3005)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/24/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The biomedical engineer (bme) reported that the (b)(6) main unit had a tcmep stim issue.They changed out the bm-122b tcmep stim cable, but the issue persisted.They swapped out the (b)(6) main unit, and this fixed the stim issue.The main unit is the device that failed of the mee system which measures and displays electric, auditory, and visual evoked potentials (ep), electroencephalograms (eeg), and electromyographs (emg).No patient harm was reported.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.The following fields contains no information (ni), as attempts to obtain information were made, but the information was not provided.A2 - a6.B6 - b7.D10 concomitant medical device.Attempt #1 (b)(6) 2024 emailed customer via microsoft outlook for all items under the no information section.No reply was received.Attempt #2 (b)(6) 2024 emailed customer via microsoft outlook for all items under the no information section.No reply was received.Attempt #3 (b)(6) 2024 emailed customer via microsoft outlook for all items under the no information section.No reply was received.Main unit model: dc-200ba.Sn: (b)(6).Device manufacturer date: 08/18/2022.Unique identifier (udi) #: (b)(4).Returned to nihon kohden: not returned.Stim pod.Model: js-201b.Sn: (b)(6).Device manufacturer date: ni.Unique identifier (udi) #: (b)(4).Returned to nihon kohden: not returned.
Event or Problem Description
The biomedical engineer (bme) reported that the (b)(6) main unit had a tcmep stim issue.They changed out the (b)(6) tcmep stim cable, but the issue persisted.They swapped out the (b)(6) main unit, and this fixed the stim issue.The main unit is the device that failed of the mee system which measures and displays electric, auditory, and visual evoked potentials (ep), electroencephalograms (eeg), and electromyographs (emg).No patient harm was reported.
Event or Problem Description
The biomedical engineer (bme) reported that the dc-200ba main unit had a tcmep stim issue.They changed out the bm-122b tcmep stim cable, but the issue persisted.They swapped out the dc-200ba main unit, and this fixed the stim issue.The main unit is the device that failed of the mee system which measures and displays electric, auditory, and visual evoked potentials (ep), electroencephalograms (eeg), and electromyographs (emg).No patient harm was reported.
Additional Manufacturer Narrative
Details of the complaint: the biomedical engineer (bme) reported that the dc-200ba main unit had a tcmep stim issue.They changed out the bm-122b tcmep stim cable, but the issue persisted.They swapped out the dc-200ba main unit, and this fixed the stim issue.The main unit is the device that failed of the mee system which measures and displays electric, auditory, and visual evoked potentials (ep), electroencephalograms (eeg), and electromyographs (emg).No patient harm was reported.Investigation conclusion: multiple follow-up requests for the return of the complaint device were sent to the customer but they were unresponsive.A definitive root cause could not be determined since we have not received the complaint device for evaluation.Possible causes may include a cable connection issue between the main unit and switch box or stim box, or hardware component failure due to physical damage or fluid intrusion from user mishandling, electrical damage from outages or surges, or wear-and-tear which depends on device age and frequency of use.Cable connection issues include loose cable through user error with set-up or use of a damaged cable which can lead to intermittent connection issues.Cables may become damaged through mishandling or wear-and-tear.Review of the complaint device's serial number does not show recurrence or other similar complaints.Main unit model: dc-200ba, sn: (b)(6) , device manufacturer date: 08/18/2022, unique identifier (udi) (b)(4) , returned to nihon kohden: not returned.Stim pod model: js-201b, sn: (b)(6), device manufacturer date: ni, unique identifier (udi) (b)(4), returned to nihon kohden: not returned.

• 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: 18753781
• Report Number: 8030229-2024-04121
• Device Sequence Number: 3703226
• 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): 05/14/2024

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: 01/24/2024
• Supplement Date Received by Manufacturer: 05/13/2024
• Initial Report FDA Received Date: 02/21/2024
• Supplement Report FDA Received Date: 05/14/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/09/2023
• 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-200BA SN (B)(6); DC-200BA SN (B)(6)
• Patient Sex: Unknown