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

Model Number	MEE-2000A
Medical Device Problem Codes	Unable to Obtain Readings (1516); Defective Component (2292); Output Problem (3005)
Health Effect - Clinical Codes	Stenosis (2263); Numbness (2415); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	07/07/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The customer reported that the stim cable was broken.According to the customer, there was no signal out for two channels, just a flat line.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.Additional model information: d10 concomitant medical device: the following device was used in conjunction with the mee-2000: jb-232b: model #: jb-232b, serial #: (b)(6), device manufacturer data: ni, unique identifier (udi) #: (b)(4), returned to nihon kohden: ni.Additional model information: d10 concomitant medical device: the following device was used in conjunction with the mee-2000: js-201b: model #: js-201b, serial #: (b)(6), device manufacturer data: ni.Unique identifier (udi) #: (b)(4), returned to nihon kohden: ni.Additional model information: d10 concomitant medical device: the following device was used in conjunction with the mee-2000: jb-210b: model #: jb-210b, serial #: (b)(6), device manufacturer data: ni, unique identifier (udi) #: (b)(4), returned to nihon kohden: ni.Additional model information: d10 concomitant medical device: the following device was used in conjunction with the mee-2000: jb-210b: model #: jb-210b, serial #: (b)(6), device manufacturer data: ni, unique identifier (udi) #: (b)(4), returned to nihon kohden: ni.Additional model information: d10 concomitant medical device: the following device was used in conjunction with the mee-2000: jb-210b: model #: jb-210b, serial #: (b)(6), device manufacturer data: ni, unique identifier (udi) #: (b)(4), returned to nihon kohden: ni.Additional model information: d10 concomitant medical device: the following device was used in conjunction with the mee-2000: jb-210b: model #: jb-210b, serial #: (b)(6), device manufacturer data: ni, unique identifier (udi) #: (b)(4), returned to nihon kohden: ni.The following fields are not applicable (na) to this report: h4 device manufacturer date.
Event or Problem Description
The customer reported that the stim cable was broken.According to the customer, there was no signal out for two channels, just a flat line.There was no patient injury reported.
Additional Manufacturer Narrative
Details of complaint: the customer reported that the stim cable was broken, causing the signal out for two channels to flatline.No patient harm was reported.Investigation summary: as no devices were returned for evaluation relating to this event, the reported issue could not be duplicated or confirmed.As such, a root cause cannot be determined.During troubleshooting, the issue was isolated to the cable.As the cable was found to be defective, it is likely that the cable or its connector were damaged.Cable damage can occur as a result of physical damage or wear and tear.Physical damage can occur to cables when bent and tugged on with excessive force resulting in internal wires breaking.Frequent pulling and bending of the cable can also cause wires to separate.The device was installed in january 2019 with no history of servicing or repair.The following fields contain no information (ni), as attempts to obtain the information were made, but not provided: a4 - a6 b6 - b7 attempt # 1: 07/11/2023 emailed the customer via microsoft outlook for all items in the ni list above: no reply was received.Attempt # 2: 07/13/2023 emailed the customer via microsoft outlook for all items in the ni list above: no reply was received.Attempt # 3 07/17/2023 emailed the customer via microsoft outlook for all items in the ni list above: the customer replied with most of the details, but could not provide all of the requested information.Additional model information: d10 concomitant medical device: the following devices were used in conjunction with the mee-2000: amp unit: model #: jb-232b serial #: (b)(6) device manufacturer data: ni unique identifier (udi) #: (b)(4) returned to nihon kohden: na stim pod: model #: js-201b serial #: (b)(6) device manufacturer data: ni unique identifier (udi) #: (b)(4) returned to nihon kohden: na mini input box: model #: jb-210b serial #: (b)(6) device manufacturer data: ni unique identifier (udi) #:(b)(4) returned to nihon kohden: na mini input box: model #: jb-210b serial #: (b)(6) device manufacturer data: ni unique identifier (udi) #: (b)(4) returned to nihon kohden: na mini input box: model #: jb-210b serial #: (b)(6) device manufacturer data: ni unique identifier (udi) #: (b)(4) returned to nihon kohden: na mini input box: model #: jb-210b serial #: (b)(6) device manufacturer data: ni unique identifier (udi) #: (b)(4) returned to nihon kohden: na additional information: b4 date of this report d10 concomitant medical device g3 date received by manufacturer g6 type of report h2 if follow-up, what type? h6 event problem and evaluation codes h10 additional manufacturer narrative.
Event or Problem Description
The customer reported that the stim cable was broken, causing the signal out for two channels to flatline.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: 17444528
• Report Number: 8030229-2023-03677
• Device Sequence Number: 2647887
• 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): 01/18/2024

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?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/07/2023
• Supplement Date Received by Manufacturer: 01/15/2024
• Initial Report FDA Received Date: 08/02/2023
• Supplement Report FDA Received Date: 01/18/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/16/2016
• 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: AMP UNIT; JB-210B S/N (B)(6); JB-210B S/N (B)(6); JB-210B S/N (B)(6); JB-210B S/N (B)(6); JB-232B S/N (B)(6); JS-201B S/N (B)(6); MINI INPUT BOX; STIM POD
• Patient Age: 47 YR
• Patient Sex: Female