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

Model Number	MEE-2000A
Medical Device Problem Code	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 customer reported that the stimulator had failed during a procedure.The customer swapped the stimulator out with a different stimulator from another machine and that system worked.At the end of the case, the customer tried another protocol with the stimulator used during the procedure that failed and again it did not work.No patient harm was reported.The customer is returning the stimulator js-201b to nihon kohden and received a replacement.The mee system measures and displays electric, auditory, and visual evoked potentials (ep), electroencephalograms (eeg), and electromyographs (emg).The device that this report is for is the js-201b serial number (b)(6).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 contain no information (ni), as attempts to obtain information were made, but not provided: a2 - a6, b6 - b7.Attempt # 1: 01/31/2024 emailed the customer via microsoft outlook for all information in the ni list above: no reply was received.Attempt # 2: 02/06/2024 emailed the customer via microsoft outlook for all information in the ni list above: no reply was received.Attempt # 3: 02/14/2024 emailed the customer via microsoft outlook for all information in the ni list above: no reply was received.Additional device information: d10 concomitant medical device: the following device(s) were used in conjunction with the mee-2000a: model #:js-201b, serial #: (b)(6), device manufacturer data: 01/24/2022, unique identifier (udi) #: (b)(4).
Event or Problem Description
The customer reported that the stimulator had failed during a procedure.The customer swapped the stimulator out with a different stimulator from another machine and that system worked.At the end of the case, the customer tried another protocol with the stimulator used during the procedure that failed and again it did not work.No patient harm was reported.The customer is returning the stimulator js-201b to nihon kohden and received a replacement.The mee system measures and displays electric, auditory, and visual evoked potentials (ep), electroencephalograms (eeg), and electromyographs (emg).
Additional Manufacturer Narrative
The customer reported that the stimulator had failed during a procedure.The customer swapped the stimulator out with a different stimulator from another machine and that system worked.At the end of the case, the customer tried another protocol with the stimulator used during the procedure that failed and again it did not work.No patient harm was reported.The customer is returning the stimulator js-201b to nihon kohden and received a replacement.The mee system measures and displays electric, auditory, and visual evoked potentials (ep), electroencephalograms (eeg), and electromyographs (emg).The device that this report is for is the concomitant medical device js-201b serial number (b)(6).Root cause investigation: nk received the complaint device on 03/01/2024.The device was evaluated on 03/05/2024 and the complaint was duplicated when using the stim pod cable that arrived with the js-201b unit.The cable connection became loose when the cable was moved, and the stim would fail the mee-2000 check utility program.The js-201b was tested with a good stim pod cable and the js-201b was found to function properly and be in good condition.The stim pod cable was found to be defective due to wear at the plug-in end and was transferred to scrap.Based on the device evaluation, the cause of the issue was physical damage to the stim pod cable.Physical damage can occur through user mishandling such as applying excessive force when inserting or removing the cable, inserting/removing the cable at an angle, or pulling the cable out without pressing the lock release tabs.The mee-2000 operator's manual includes instructions for properly connecting and removing the stim pod cable.Review of the customer's complaint history shows that similar complaints did not result in patient harm.Nk will continue to monitor and trend similar complaints.Additional device information: d10 concomitant medical device: the following device(s) were used in conjunction with the mee-2000a: model #:js-201b serial #: (b)(6) device manufacturer data: 01/24/2022 unique identifier (udi) #: (b)(4).
Event or Problem Description
The customer reported that the stimulator had failed during a procedure.The customer swapped the stimulator out with a different stimulator from another machine and that system worked.At the end of the case, the customer tried another protocol with the stimulator used during the procedure that failed and again it did not work.No patient harm was reported.The customer is returning the stimulator js-201b to nihon kohden and received a replacement.The mee system measures and displays electric, auditory, and visual evoked potentials (ep), electroencephalograms (eeg), and electromyographs (emg).

• 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: 18722445
• Report Number: 8030229-2024-04125
• Device Sequence Number: 14904272
• 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: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/03/2024

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?: Device Returned to Manufacturer
• 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: 04/30/2024
• Initial Report FDA Received Date: 02/16/2024
• Supplement Report FDA Received Date: 05/03/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/02/2022
• 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: 8 HIGH STIM, 2 LOW STIM OUTPUT (A-POD) PN JS-201B.; 8 HIGH STIM, 2 LOW STIM OUTPUT (A-POD) PN JS-201B.
• Patient Sex: Unknown