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

Model Number	MEE-2000A-DT
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	12/01/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The customer reported that when launching an ssep examination in the or (with a patient on the table), the mee 2000 system gave a "somato high" error message for the electrical stimulator, then shut down.The machine was swapped with a working one to continue patient monitoring during the procedure.Technical support (ts) later tried to restore the protocols and correct a permissions issue, but the issue persisted when testing the stimulator.Per the mee manual, this issue could be caused by a defective cable.They will be provided with a quote for a replacement a-bank stim pod kit, which includes the needed cable.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.
Event or Problem Description
The customer reported that when launching an ssep examination in the or (with a patient on the table), the mee 2000 system gave a "somato high" error message for the electrical stimulator, then shut down.
Event or Problem Description
The customer reported that when launching an ssep examination in the or (with a patient on the table), the mee 2000 system gave a "somato high" error message for the electrical stimulator, then shut down.
Additional Manufacturer Narrative
Details of complaint: the customer reported that when launching an ssep examination in the or (with a patient on the table), the mee 2000 system gave a "somato high" error message for the electrical stimulator, then shut down.The machine was swapped with a working one to continue patient monitoring during the procedure.Technical support (ts) later tried to restore the protocols and correct a permissions issue, but the issue persisted when testing the stimulator.Per the mee manual, this issue could be caused by a defective cable.They will be provided with a quote for a replacement a-bank stim pod kit, which includes the needed cable.No harm or injury was reported.Investigation summary: nihon kohden was able to confirm the reported issue was due to the main unit needing replacement.A definitive root cause of how the issue with the main unit occurred is unknown, as the device was not returned for evaluation.However, it is possible the issue with the main unit was due to damage from wear and tear during use, which may result in blown fuses.The customer was advised to work with their ae to replace the main unit, to resolve the issue.Potential causes could be main unit issues, stim overload issues, stim fuses, stimulator issues, cable issues, and settings issues.

• 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: 16061918
• Report Number: 8030229-2022-03264
• Device Sequence Number: 16646432
• Product Code: GWF
• UDI-Device Identifier: 00841983103612
• UDI-Public: 00841983103612
• Combination Product (Y/N): N
• Initial Reporter State: IN
• 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): 04/18/2023

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-DT
• Device Catalogue Number: MEE-2000A-DT
• 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: 12/01/2022
• Supplement Date Received by Manufacturer: 03/27/2023
• Initial Report FDA Received Date: 12/28/2022
• Supplement Report FDA Received Date: 04/18/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/14/2021
• 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