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

Model Number	MEE-2000A
Medical Device Problem Codes	Loss of Power (1475); Power Problem (3010)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/13/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The customer reported that this electrical box stopped outputting power during a procedure.According to the customer, it was right before the end so there were no problems.The customer will send in the unit to be exchanged.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 attempt # 1: 06/27/2023 emailed the customer via microsoft outlook for patient information: no reply was received.Attempt # 2: 06/29/2023 emailed the customer via microsoft outlook for patient information: no reply was received.Attempt # 3 07/05/2023 emailed the customer via microsoft outlook for patient information: no reply was received.B6 attempt # 1: 06/27/2023 emailed the customer via microsoft outlook for patient information: no reply was received.Attempt # 2: 06/29/2023 emailed the customer via microsoft outlook for patient information: no reply was received.Attempt # 3 07/05/2023 emailed the customer via microsoft outlook for patient information: no reply was received.B7 attempt # 1: 06/27/2023 emailed the customer via microsoft outlook for patient information: no reply was received.Attempt # 2: 06/29/2023 emailed the customer via microsoft outlook for patient information: no reply was received.Attempt # 3 07/05/2023 emailed the customer via microsoft outlook for patient information: no reply was received.D4 serial number attempt # 1: 06/27/2023 emailed the customer via microsoft outlook for patient information: no reply was received.Attempt # 2: 06/29/2023 emailed the customer via microsoft outlook for patient information: no reply was received.Attempt # 3 07/05/2023 emailed the customer via microsoft outlook for patient information: no reply was received.The following fields are not available (n/a) to this report: h4 device manufacturer date.Additional model information: d10 concomitant medical device: the following device was used in conjunction with the mee2000: js-201b: model #: js-201b.Serial #: ni.Device manufacturer data: ni.Unique identifier (udi) #: (b)(4).Returned to nihon kohden: ni.
Event or Problem Description
The customer reported that this electrical box stopped outputting power during a procedure.There was no patient injury reported.
Event or Problem Description
The customer reported that this electrical box stopped outputting power during a procedure.There was no patient injury reported.
Additional Manufacturer Narrative
Details of complaint: the customer reported that this electrical box stopped outputting power during a procedure.According to the customer, it was right before the end so there were no problems.The customer will send in the unit to be exchanged.There was no patient injury reported.Investigation summary: there were no issues found with the device itself during evaluation, as it was working normally.However, we confirmed a secondary issue, (found during evaluation of the device), with the connection cable, (that connects to the main unit, which was replaced during the evaluation process).The connection cable issue was likely due to damage (from either wear and tear and/or mishandling), which are likely contributing causes of the reported issue.The following fields contain no information (ni), as attempts to obtain information were made, but not provided: a2 - a6.Attempt # 1: 06/27/2023 emailed the customer via microsoft outlook for patient information: no reply was received.Attempt # 2: 06/29/2023 emailed the customer via microsoft outlook for patient information: no reply was received.Attempt # 3 07/05/2023 emailed the customer via microsoft outlook for patient information: no reply was received.B6 attempt # 1: 06/27/2023 emailed the customer via microsoft outlook for patient information: no reply was received.Attempt # 2: 06/29/2023 emailed the customer via microsoft outlook for patient information: no reply was received.Attempt # 3 07/05/2023 emailed the customer via microsoft outlook for patient information: no reply was received.B7 attempt # 1: 06/27/2023 emailed the customer via microsoft outlook for patient information: no reply was received.Attempt # 2: 06/29/2023 emailed the customer via microsoft outlook for patient information: no reply was received.Attempt # 3 07/05/2023 emailed the customer via microsoft outlook for patient information: no reply was received.D4 serial number.Attempt # 1: 06/27/2023 emailed the customer via microsoft outlook for patient information: no reply was received.Attempt # 2: 06/29/2023 emailed the customer via microsoft outlook for patient information: no reply was received.Attempt # 3 07/05/2023 emailed the customer via microsoft outlook for patient information: no reply was received.The following fields are not available (n/a) to this report: h4 device manufacturer date additional model information: d10 concomitant medical device: the following device was used in conjunction with the mee2000: js-201b: model #: js-201b.Serial #: (b)(6).Device manufacturer date: 04/24/2019.Unique identifier (udi) #: (b)(4).Returned to nihon kohden: ni.Additional information: b4 date of this report.D9 device available for evaluation? g3 date received by manufacturer.G6 type of report.H2 if follow up, what type? h3 device evaluated by manufacturer? h10 additional manufacturer narrative.Manufacturer references # (b)(4) follow up 001.

• 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: 17307934
• Report Number: 8030229-2023-03654
• Device Sequence Number: 7213983
• Product Code: GWF
• UDI-Device Identifier: 04931921118054
• UDI-Public: 04931921118054
• 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): 09/22/2023

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
• 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: 06/13/2023
• Supplement Date Received by Manufacturer: 09/19/2023
• Initial Report FDA Received Date: 07/12/2023
• Supplement Report FDA Received Date: 09/22/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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: JS-201B.; JS-201B.
• Patient Sex: Unknown