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 Codes	No Consequences Or Impact To Patient (2199); No Information (3190)
Date of Event	05/31/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The dc-110b main unit which has the stimming controls, becomes disconnected from the mee-1000a pc system which is used for evoked potentials, eegs, and emgs.The mee-1000a software needs to be restarted for the device to be operable.The event logs will be sent to nihon kohden for evaluation.The unit was in use on patients at the time, but 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.
Event or Problem Description
The dc-110b main unit which has the stimming controls, becomes disconnected from the mee-1000 pc system which is used for evoked potentials, eegs, and emgs.The mee-1000a software needs to be restarted for the device to be operable.
Additional Manufacturer Narrative
The dc-110b main unit which has the stimming controls, becomes disconnected from the mee-1000a pc system which is used for evoked potentials, eegs, and emgs.The mee-1000a software needs to be restarted for the device to be operable.The event logs have been sent to nihon kohden for evaluation.The unit was in use on patients at the time, but no patient harm was reported.After the evaluation, the issue was determined to be caused by a combination of the load to pc being increased and the use of software not recommended to be used with the device.

• 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: 6668623
• Report Number: 8030229-2017-00207
• Device Sequence Number: 1971168
• Product Code: GWF
• UDI-Device Identifier: 04931921102879
• UDI-Public: 04931921102879
• Combination Product (Y/N): N
• Initial Reporter State: MN
• 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: Hospital Service Technician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/26/2017
• Report Date (Section F): 06/26/2017

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?: No
• Distributor Facility Aware Date: 06/06/2017
• Device Age: 18 MO
• Event Location: Hospital
• Date Report to Manufacturer: 06/26/2017
• Initial Date Received by Manufacturer: 06/26/2017
• Supplement Date Received by Manufacturer: 06/26/2017
• Initial Report FDA Received Date: 06/26/2017
• Supplement Report FDA Received Date: 10/16/2017
• 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: 06/26/2017