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

Model Number	MEB-9400A
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
Date of Event	11/09/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The customer reported that the emg (electromyography) data recorded under another patient's node.We contacted to the customer to verify if this was done in user error where an incorrect patient name was chosen when the study was started.However, the customer was not sure how it happened and stated that this was a single-time occurrence.We did ask to look into their device remotely to collect information but they refused to do that.No patient harm or 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 if additional information becomes available.
Event or Problem Description
The customer reported that the emg (electromyography) data recorded under another patient's node.We contacted to the customer to verify if this was done in user error where an incorrect patient name was chosen when the study was started.However, the customer was not sure how it happened and stated that this was a single-time occurrence.We did ask to look into their device remotely to collect information but they refused to do that.No patient harm or injury reported.
Additional Manufacturer Narrative
Additional information: f7.Type of report? g7.Type of report h2.If follow-up, what type? h10.Additional manufacture narrative.Correct data: h10.Additional manufacture narrative: details of complaint: getting duplicate files generated when performing ncs and emg tests.Customer reports that they are getting duplicate files generated when performing ncs and emg tests.Nka remoted into the system and saw the problem.Customer reports that they are having this issue intermittently.This appears to be happening mainly with ncs tests and not emg's.Today, they had some files from one patient saved into another patient's nwb patient node and they had generated a report for this patient's exams with the correct data before finalizing the data and we were able to separate those files out and place them under the correct patient node and generate a new report.Service requested: troubleshooting.Service performed: troubleshooting.Investigation result: the customer reported that the emg (electromyography) data recorded under another patient's node.We contacted to the customer to verify if this was done in user error where an incorrect patient name was chosen when the study was started.However, the customer was not sure how it happened and stated that this was a single-time occurrence.We did ask to look into their device remotely to collect information, but they refused to do that.No patient harm or injury reported.

• Brand Name: MEB-9400A
• Common Device Name: ELECTROMYOGRAPH
• Manufacturer (Section D): NIHON KOHDEN CORPORATION; 1-31-4 nishiochia, shinjuku-ku; attn: shama mooman; tokyo, 161-8 560; JA 161-8560
• MDR Report Key: 8144261
• Report Number: 8030229-2018-00463
• Device Sequence Number: 1887273
• Product Code: IKN
• UDI-Device Identifier: 04931921102183
• UDI-Public: 04931921102183
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K010590
• Number of Events Summarized: 1
• Summary Report (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): 12/07/2018
• Report Date (Section F): 12/07/2018

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
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 11/09/2018
• Device Age: 47 MO
• Event Location: Hospital
• Date Report to Manufacturer: 12/07/2018
• Initial Date Received by Manufacturer: 12/07/2018
• Supplement Date Received by Manufacturer: 12/07/2018
• Initial Report FDA Received Date: 12/07/2018
• Supplement Report FDA Received Date: 04/04/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Date Report Sent to FDA: 12/07/2018