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

Model Number	MEE-2000A
Medical Device Problem Codes	Failure to Deliver Energy (1211); 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
Event or Problem Description
The customer reported that an electric a stim box #352 did not work on a case.The customer changed both the cable and stim box from another machine and the system worked.There was no patient injury reported.
Additional Manufacturer Narrative
The customer reported that an electric a stim box #352 did not work on a case.The customer changed both the cable and stim box from another machine and the system worked.At the end of the case, the customer tried another protocol with stim box 352 and it did not work again.The stim box is being exchanged.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.The following fields contain no information (ni), as attempts to obtain information were made, but not provided: a2 - a6 attempt # 1: 01/30/2024 emailed the customer via microsoft outlook for patient information: no reply was received.Attempt # 2: 02/06/2024 emailed the customer via microsoft outlook for patient information: no reply was received.Attempt # 3 02/13/2024 emailed the customer via microsoft outlook for patient information: no reply was received.B6 attempt # 1: 01/30/2024 emailed the customer via microsoft outlook for patient information: no reply was received.Attempt # 2: 02/06/2024 emailed the customer via microsoft outlook for patient information: no reply was received.Attempt # 3 02/13/2024 emailed the customer via microsoft outlook for patient information: no reply was received.B7 attempt # 1: 01/30/2024 emailed the customer via microsoft outlook for patient information: no reply was received.Attempt # 2: 02/06/2024 emailed the customer via microsoft outlook for patient information: no reply was received.Attempt # 3 02/13/2024 emailed the customer via microsoft outlook for patient information: no reply was received.D4 serial number attempt # 1: 01/30/2024 emailed the customer via microsoft outlook for device information: no reply was received.Attempt # 2: 02/06/2024 emailed the customer via microsoft outlook for device information: no reply was received.Attempt # 3 02/13/2024 emailed the customer via microsoft outlook for device 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 mee-2000: dc-200ba: model #:dc-200ba, serial #: (b)(6), device manufacturer date: 11/02/2022, unique identifier (udi) #: (b)(4), returned to nihon kohden: no.
Additional Manufacturer Narrative
Details of complaint: the customer reported that an electric a stim box #352 did not work on a case.The customer changed both the cable and stim box from another machine and the system worked.At the end of the case, the customer tried another protocol with stim box 352 and it did not work again.The stim box is being exchanged.There was no patient injury reported.Investigation summary: the complaint device was received by nihon kohden (nk) on 03/07/2024.The device was evaluated on 03/18/2024 and the complaint could not be duplicated.The unit operated normally without any issues during testing.A definitive root cause could not be determined as we could not duplicate the complaint during evaluation.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 mee-2000: dc-200ba: model #:dc-200ba serial #: (b)(6) device manufacturer date: 11/02/2022 unique identifier (udi) #: (b)(4) returned to nihon kohden: no additional information: b4 date of this report d9 is this device available for evaluation? g3 date received by manufacturer g6 type of report h2 if follow up, what type? h3 device evaluated by manufacturer? h11 additional manufacturer narrative manufacturer references # (b)(4).Follow up 001.
Event or Problem Description
The customer reported that an electric a stim box #352 did not work on a case.The customer changed both the cable and stim box from another machine and the system worked.There was no patient injury 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: 18759522
• Report Number: 8030229-2024-04122
• Device Sequence Number: 17103365
• 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: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/06/2024

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: 05/01/2024
• Initial Report FDA Received Date: 02/22/2024
• Supplement Report FDA Received Date: 05/06/2024
• 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