MAUDE Adverse Event Report: NIHON KOHDEN CORPORATION MEE-1000A; EVOKED RESPONSE ELECTRIC STIMULATOR

Model Number	MEE-1000A
Medical Device Problem Code	Device Operates Differently Than Expected (2913)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/27/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The customer reported that during an or procedure that the mee-1000 was not receiving any stimulus output.The mee-1000 system is used for evoked potentials, eegs, and emgs.The stim pods which were part of the system were not producing stimulus output.Shutting down and restarting the system corrected the issue.They were able to resume.The unit was in use on patients at the time, but no patient harm was reported.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 during an or procedure that the mee-1000 was not receiving any stimulus output.The mee-1000 system is used for evoked potentials, eegs, and emgs.

• Brand Name: MEE-1000A
• Common Device Name: EVOKED RESPONSE ELECTRIC STIMULATOR
• Manufacturer (Section D): NIHON KOHDEN CORPORATION; 1-31-4 nishiochia, shinjuku-ku; attn: shama mooman; tokyo, japan 161-8 560; JA 161-8560
• MDR Report Key: 6818812
• Report Number: 8030229-2017-00272
• Device Sequence Number: 137707
• Product Code: GWF
• UDI-Device Identifier: 04931921102879
• UDI-Public: 04931921102879
• Combination Product (Y/N): N
• Initial Reporter State: IA
• Initial Reporter Country: US
• PMA/510(K) Number: K051178
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date (Section B): 08/24/2017
• Report Date (Section F): 08/24/2017

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-1000A
• Device Catalogue Number: MEE-1000A
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 07/27/2017
• Device Age: 84 MO
• Event Location: Hospital
• Date Report to Manufacturer: 08/24/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/24/2017
• Initial Report FDA Received Date: 08/24/2017
• 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: 08/24/2017