MAUDE Adverse Event Report: NIHON KOHDEN CORPORATION MEB-9400A; ELECTROMYOGRAPH

Model Number	MEB-9400A
Medical Device Problem Code	Energy Output Problem (1431)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/17/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The eeg tech reported that the stimulator connected to the meb-9400a system would no longer deliver stimulation, and that the stimulation intensity was changing on its own.The meb is used for emg and ep (evoked potential).The stimulator will be returned for an exchange without the meb-9400a system.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: serial number, age of the device, device manufacture date.Additional device information: concomitant medical device.The following device was used in conjunction with the meb-6400a and is the device that experienced the failure: hand held stimulator, model #: ry-441b, sn #: ni.
Event or Problem Description
The eeg tech reported that the stimulator connected to the meb-9400a system would no longer deliver stimulation, and that the stimulation intensity was changing on its own.The meb is used for emg and ep (evoked potential).The stimulator will be returned for an exchange without the meb-9400a system.No patient harm was reported.
Additional Manufacturer Narrative
Details of complaint: the eeg tech reported that the stimulator connected to the meb-9400a system would no longer deliver stimulation, and that the stimulation intensity was changing on its own.The meb is used for emg and ep (evoked potential).A new stimulator (ry-441b) was purchased by the customer from customer service on (b)(6) 2019, to resolve the issue.No patient harm was reported.Service requested / performed: troubleshooting.Investigation summary: the possible cause of the issue, as suggested by nihon kohden technical support (nk ts), could be physical damage to the stimulator probe.Due to the unavailability of the device, a visual and functionality evaluation could not be performed.The reported issue does not require further investigation through capa process since the issue could possibly be caused due to the physical damage to the unit and not an nk device deviation/malfunction.The following fields contain no information (ni), as attempts to obtain information were made, but not provided: a2 - a6 patient information.D4 serial number.F9 age of the device.H4 device manufacture date.Additional device information: d10 concomitant medical device: the following device was used in conjunction with the meb-6400a: hand held stimulator: model #: ry-441b.Serial #: ni.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 eeg tech reported that the stimulator connected to the meb-9400a system would no longer deliver stimulation, and that the stimulation intensity was changing on its own.No patient harm was reported.

• Brand Name: MEB-9400A
• Common Device Name: ELECTROMYOGRAPH
• 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 ; safety mgmt dept, quality mgmt; seibu bldg 2, 4th floor 1-11-2; kusunokidai tokorozawa, saitama 359-8-580 ; JA 359-8580
• MDR Report Key: 9189063
• Report Number: 8030229-2018-00571
• Device Sequence Number: 14065495
• Product Code: IKN
• UDI-Device Identifier: 04931921102183
• UDI-Public: 04931921102183
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K010590
• 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): 02/17/2022
• Report Date (Section F): 10/14/2019

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: MEB-9400A
• Device Catalogue Number: MEB-9400A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 09/17/2019
• Event Location: Hospital
• Date Report to Manufacturer: 10/14/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/17/2019
• Supplement Date Received by Manufacturer: 02/08/2022
• Initial Report FDA Received Date: 10/14/2019
• Supplement Report FDA Received Date: 02/17/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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: HAND HELD STIMULATOR; RY-441B NO SN
• Patient Sex: Unknown
• Date Report Sent to FDA: 10/14/2019