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	12/21/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported that the stimulation pod was not staying connected during a patient's examination and would not reconnect.No patient harm was reported.
Additional Manufacturer Narrative
The customer reported that the stimulation pod was not staying connected during a patient's examination and would not reconnect.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.Additional device information: d10 concomitant medical device: the following device was used in conjunction with the mee-2000a and is the device that experienced the failure: stim a pod: model #: js-201b serial #: (b)(6) device manufacturer data: ni.Unique identifier (udi) #: ni.Returned to nihon kohden: na.
Event or Problem Description
The customer reported that the stimulation pod was not staying connected during a patient's examination and would not reconnect.No patient harm was reported.
Additional Manufacturer Narrative
Details of complaint: the customer reported that the stimulation pod was not staying connected during a patient's examination and would not reconnect.No patient harm was reported.Investigation summary: the stimulation pod that was in use with the mee-2000 was sent in for an exchange and evaluation.On 02/29/2023, the unit was cleaned and decontaminated.Nihon kohden repair center (nk rc) evaluated the stimulation pod cable by performing a test exam.The results confirmed the customer's complaint.Nk rc used a known working stimulation pod cable and the results were successful.Next, nk rc performed a constant current output intensity test and the amplitude of the waveform in oscilloscope was verified at (+/-5%) from a1 to a8.The repair technician concluded the stimulation pod cable was defective and would be scrapped.However, the js-201b stimulation pod was functioning properly.The root cause was determined to be a cable connectivity issue.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.Although there was patient involvement, there was no injury, no harm, nor any adverse event, due to the reported issue.During a review of the device history for the reported issue, two similar issues were discovered for similar devices (product id: js-201b stimulation pod), with similar serial numbers (sn: 907), that occurred at this facility around the same time frame.These similar complaints were discovered over the past year and are as follows: ticket #198082 (reported on 12/21/2023) and ticket #199256 (reported on 01/12/2024).A review of the complaint history does not reveal a significant trend that would contribute to component failure that is related to the design or manufacturing of the device.Nk will continue to monitor and trend for this device, facility, and for similar complaint issues.The following fields contain no information (ni), as attempts to obtain the information were made, but not provided: a2 - a6 b6 - b7 attempt # 1: 01/11/2024 emailed the customer via microsoft outlook for all information in the ni list above: no reply was received.Attempt # 2: 01/11/2024 emailed the customer via microsoft outlook for all information in the ni list above: the customer replied, stating that none of the patient information could be provided.Attempt # 3: 01/15/2024 emailed the customer via microsoft outlook the model and sn of the mee-2000 device: the customer replied with the model and sn of the mee-2000 device.Additional device information: d10 concomitant medical device: the following device was used in conjunction with the mee-2000a and is the device that experienced the failure and was brought in for evaluation and exchange: stim a pod: model #: js-201b serial #: (b)(6) device manufacturer data: ni unique identifier (udi) #: ni returned to nihon kohden: 02/08/2024.
Additional Manufacturer Narrative
Details of complaint: the customer reported that the stimulation pod was not staying connected during a patient's examination and would not reconnect.No patient harm was reported.Investigation summary: the reported device was sent in for an exchange and evaluation.On 02/29/2023, the unit was cleaned and decontaminated.Nihon kohden repair center (nk rc) evaluated the stim pod cable by performing a test exam.The results confirmed the customer's complaint.Nk rc used a known working stim pod cable and the results were successful.Next, nk rc performed a constant current output intensity test and the amplitude of the waveform in oscilloscope was verified at (+/-5%) from a1 to a8.The repair technician concluded the stim pod cable was defective and would be scrapped.However, the js-201b stim pod was functioning properly.The root cause was determined to be a cable connectivity issue.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.Although there was patient involvement, there was no injury, no harm, nor any adverse event, due to the reported issue.During a review of the device history for the reported issue, two similar issues were discovered for similar devices (product id: js-201b), with similar serial numbers (sn: (b)(6)), that occurred at this facility around the same time frame.These similar complaints were discovered over the past year and are as follows: ticket #(b)(4) (reported on 12/21/2023) and ticket #(b)(4) (reported on 01/12/2024).A review of the complaint history does not reveal a significant trend that would contribute to component failure that is related to the design or manufacturing of the device.Nk will continue to monitor and trend for this device, facility, and for similar complaint issues.Additional device information: d10 concomitant medical device: the following device was used in conjunction with the mee-2000a and is the device that experienced the failure: stim a pod: model #: js-201b.Serial #: (b)(6).Device manufacturer data: ni.Unique identifier (udi) #: ni.Returned to nihon kohden: 02/08/2024.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? h6 event problem and evaluation codes h11 additional manufacturer narrative.
Event or Problem Description
The customer reported that the stimulation pod was not staying connected during a patient's examination and would not reconnect.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: 18531524
• Report Number: 8030229-2024-04072
• Device Sequence Number: 20527914
• 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,Followup
• Report Date (Section B): 03/04/2024

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: 12/21/2023
• Supplement Date Received by Manufacturer: 02/29/2024; 02/29/2024
• Initial Report FDA Received Date: 01/17/2024
• Supplement Report FDA Received Date: 03/01/2024; 03/04/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/25/2019
• 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: STIMULATION POD; STIMULATION POD; STIMULATION POD
• Patient Sex: Unknown