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

Model Number	MEE-2000A-LT
Medical Device Problem Codes	Power Problem (3010); Complete Loss of Power (4015)
Health Effect - Clinical Codes	No Known Impact Or Consequence To Patient (2692); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/10/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The duration of the event was less than 2 minutes.The user was not touching the unit or inputting any commands at the time.They also did not bump the power cord or any of the cords behind the unit.There was no patient injury 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 eeg tech reported that the mee system shut down and restarted during a 4ext cervical procedure.The mee-2000a is an iom system which is used for evoked potentials, eegs, and emgs.
Additional Manufacturer Narrative
Details of complaint: on (b)(6) 2021, the customer reported that during a 4ext cervical case, the mee-2000a-lt unit shut down and restarted.The duration of the event was less than 2 minutes.The user was not touching the unit or inputting any commands at the time.They also did not bump the power cord or any of the cords behind the unit.The nihonkohden (nk) technical support (ts) agent contacted the customer and confirmed the reported problem.The ts agent found out that the reported problem was resolved when the reported unit restarted within 2 mins.However, after initial contact ts agent was not able to connect with the customer.No patient harm was reported.Service requested / performed: troubleshooting.Investigation summary: the overall risk of this event is "medium." the root cause of the reported problem could not be determined with the provided information.Since the root cause was unable to be determined, no capa is required.
Event or Problem Description
The eeg tech reported that the mee system shut down and restarted during a 4ext cervical procedure.The mee-2000a is an iom system which is used for evoked potentials, eegs, and emgs.

• 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
• MDR Report Key: 8761452
• Report Number: 8030229-2019-00277
• Device Sequence Number: 14112889
• Product Code: GWF
• UDI-Device Identifier: 00841983103629
• UDI-Public: 00841983103629
• Combination Product (Y/N): N
• Initial Reporter State: OK
• 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): 08/03/2021
• Report Date (Section F): 07/03/2019

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
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 06/10/2019
• Device Age: 14 MO
• Event Location: Hospital
• Date Report to Manufacturer: 07/03/2019
• Initial Date Received by Manufacturer: 06/10/2019
• Supplement Date Received by Manufacturer: 06/18/2021
• Initial Report FDA Received Date: 07/03/2019
• Supplement Report FDA Received Date: 08/03/2021
• 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: 07/03/2019