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

Model Number	MEE-2000A-LT
Medical Device Problem Codes	Loose or Intermittent Connection (1371); Connection Problem (2900)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/13/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The biomedical engineer (bme) reported that their main unit had a bad amplifier cable.They swapped the cable with a known working one, which resolved the issue.It was unknown if the unit was in inpatient use when the issue 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.The following fields contain no information (ni), as attempts to obtain information were made, but not provided:.
Event or Problem Description
The biomedical engineer (bme) reported that their main unit had a bad amplifier cable.No patient harm was reported.
Additional Manufacturer Narrative
Details of complaint: the biomedical engineer (bme) reported that the mee-2000a main unit had a bad amplifier cable.They swapped the cable with a known working one, which resolved the issue.It was unknown if the unit was in inpatient use when the issue occurred.No patient harm was reported.Technical support (ts) provided the customer with a quote for a new cable.The unit had a standard warranty from 01/17/2023 to 01/17/2024, making the device age approximately one year old.Ts followed up with the customer on 12/28/2023, 02/29/2024, 03/19/2024, 03/27/2024, and 04/09/2024 but the customer was unresponsive to all attempts have them send their defective cable back to nihon kohden.Typically, damage to cables, inputs, outputs, and connectors could occur when excessive force is exerted or when the cable comes into repeated contact with a surface or objects.These events could damage the wiring, connectors, and/or the tubing which can lead to electrocution or fire.Due to lack of response from the customer, the cable was not sent back for evaluation, therefore, a definitive root cause of the defective cable could not be determined.During a review of the device history for the reported issue, we found only one issue that occurred at this facility: ticket #196960 (reported on 12/13/2023).A review of the device history does not reveal a significant trend that would contribute to component failure that is related to the design or manufacturing of the device.We will continue to trend for this device and facility for similar complaint issues.The following fields contain no information (ni), as attempts to the obtain information were made, but not provided: a2 - a6 b6 - b7 d10 attempt # 1: 12/15/2023 emailed the bme for all items under the no information list.No reply was received.Attempt # 2: 12/19/2023 emailed the bme for all items under the no information list.No reply was received.Attempt # 3: 12/28/2023 emailed the bme for all items under the no information ist.No reply was received.
Event or Problem Description
The biomedical engineer (bme) reported that the mee-2000a main unit had a bad amplifier cable.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: 18485659
• Report Number: 8030229-2024-04038
• Device Sequence Number: 9133910
• 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): 04/19/2024

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: 12/13/2023
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/10/2024
• Supplement Report FDA Received Date: 04/19/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/18/2023
• 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