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

Model Number	MEE-2000A-LT
Medical Device Problem Codes	Connection Problem (2900); Unexpected Shutdown (4019)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/08/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The biomedical engineer (bme) reported having issues with the patch cable connection between their laptop and the nk main unit.They received an error message stating connection error failure when starting the main unit.However, it happened two times during a procedure, and they had to reboot and hold the cable in to get it to start.They tried switching between multiple cables, but the error still occurred.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 biomedical engineer (bme) reported having issues with the patch cable connection between their laptop and the nk main unit.They received an error message stating connection error failure when starting the main unit.However, it happened two times during a procedure, and they had to reboot and hold the cable in to get it to start.They tried switching between multiple cables, but the error still occurred.No patient harm was reported.
Additional Manufacturer Narrative
Details of complaint: the biomedical engineer (bme) reported having issues with the patch cable connection between their laptop and the nk main unit.They received an error message stating connection error failure when starting the main unit.However, it happened two times during a procedure, and they had to reboot and hold the cable in to get it to start.They tried switching between multiple cables, but the error still occurred.No patient harm was reported.Investigation summary: the customer reported no further issues.They were instructed by nka tech support to be more careful when moving the system during procedures.As such, it is likely that the cause of the issue is improper movement of the device during use and is related to user education.Movement may have caused cables not to be properly seated in their connectors and caused errors.It is also possible that damage to the cable or connectors would cause the issue to occur when the system is moved.Cable damage can occur as a result of physical damage or wear and tear.Physical damage can occur to cables should they be bent and tugged on with excessive force, resulting in internal wires breaking.Frequent pulling and bending of the cable can also cause wires to separate.The cause of the issue is likely related to the movement of the system during a procedure based on what the customer reported.There is no evidence of an nk device malfunction that may have contributed to the reported issue.This issue will be tracked for future occurrences.Attempt # 1: 12/28/2023 emailed the bme for all items under the no information list.No reply was received.Attempt # 2: 01/03/2024 emailed the bme for all items under the no information list.No reply was received.Attempt # 3: 01/05/2024 emailed the bme for all items under the no information list.No reply was received.
Event or Problem Description
The biomedical engineer (bme) reported having issues with the patch cable connection between their laptop and the nk main unit.They received an error message stating connection error failure when starting the main unit.However, it happened two times during a procedure, and they had to reboot and hold the cable in to get it to start.They tried switching between multiple cables, but the error still occurred.No patient harm was reported.

• 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: 18461132
• Report Number: 8030229-2024-04032
• Device Sequence Number: 11542033
• Product Code: GWF
• UDI-Device Identifier: 00841983103629
• UDI-Public: 00841983103629
• 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): 03/20/2024

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-LT
• Device Catalogue Number: MEE-2000A-LT
• 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: 12/08/2023
• Supplement Date Received by Manufacturer: 03/19/2024
• Initial Report FDA Received Date: 01/06/2024
• Supplement Report FDA Received Date: 03/20/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/18/2023
• 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
• Patient Sex: Unknown