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

Model Number	MEE-2000A-DT
Medical Device Problem Codes	Connection Problem (2900); Incomplete or Inadequate Connection (4037)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/22/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Details of complaint: on (b)(6) 2020, the customer reported the following issue with pc a/dell-7050sff-w10; sn-(b)(4), (registered to mee-2000a-dt-w10) from neurology: during a study in the operating room, the mee-2000-dt performed several instances of switching from disconnecting and then reconnecting to the main unit.Service requested: troubleshooting.Service performed: troubleshooting was performed on (b)(6) 2020.Nk ts remoted into the unit but did not encounter the error.Customer was asked to check for tightness of the lan cable between the main unit and the dt computer and reseated the cable on both ends.Was also asked to depress both the a and b buttons on the base and see if resetting it would fix the problem.Nk ts found that the network was plugged into the "ethernet," which is the default the nk software installer uses.Ts modified the batch file on this machine to say "onboard" then right clicked and ran as administrator (requiring a password), which set the ip static to that nic.Investigation summary: investigation determined the issue poses medium risk.The device was in use on a patient at the time of the incident, but no patient harm was reported.The root cause of the issue was determined to be that the install settings were not changed to user settings.The reported issue does not require further investigation through capa process since the incident occurred due to human error and not due to non-conformance of the nk product.
Event or Problem Description
The customer reported that the mee-2000-dt performed several instances of switching from disconnecting and then reconnecting to the main unit during a procedure.

• Brand Name: MEE-2000A
• Common Device Name: EVOKED RESPONSE ELECTRIC STIMULATOR
• Manufacturer (Section D): NIHON KOHDEN CORPORATION; 1-31-4 nishiochia, shinjuku-ku; attn: shama mooman; tokyo, 161-8 560; JA 161-8560
• MDR Report Key: 10439932
• Report Number: 8030229-2020-00464
• Device Sequence Number: 16881272
• Product Code: GWF
• UDI-Device Identifier: 00841983103612
• UDI-Public: 00841983103612
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K142624
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 08/21/2020
• Report Date (Section F): 08/21/2020

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
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 07/22/2020
• Device Age: 7 MO
• Event Location: Hospital
• Date Report to Manufacturer: 08/21/2020
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/22/2020
• Initial Report FDA Received Date: 08/21/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Date Report Sent to FDA: 08/21/2020