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

Model Number	MEE-1000A
Medical Device Problem Code	Audible Prompt/Feedback Problem (4020)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/03/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The ear inserts that provide aep (auditory evoked potentials) stimulation during an mee-1000 procedure stimulated the incorrect sides.The mee-1000 pc system is used for evoked potentials, eegs, and emgs.These ear inserts had these issues years ago and the manufacturer of the ear inserts has since then corrected the issue.The customer had the old inserts that had these issues, and they were provided replacement inserts that are functioning correctly.
Event or Problem Description
The ear inserts that provide aep (auditory evoked potentials) stimulation during an mee-1000 procedure stimulated the incorrect sides.The mee-1000 pc system is used for evoked potentials, eegs, and emgs.These ear inserts had these issues years ago and the manufacturer of the ear inserts has since then corrected the issue.The customer had the old inserts that had these issues, and they were provided replacement inserts that are functioning correctly.
Additional Manufacturer Narrative
Customer recently discovered an issue with aep stimulation using the ear inserts.The left stimulus is coming out of the red box, and the right stimulus is coming out of the blue box.The ear inserts that provide aep (auditory evoked potentials) stimulation during an mee-1000 procedure stimulated the incorrect sides.The left stimulated the right and the right stimulated the left.These ear inserts had these issues years ago and the manufacturer of the ear inserts has since then corrected the issue.The customer had the old inserts that had these issues, and they were provided replacement inserts that are functioning correctly.Based on the given information, this complaint record can be considered low risk and will be closed as no further investigation is needed at this time.
Additional Manufacturer Narrative
Details of the complaint: on 07/03/2018, customer at cleveland clinic health system reported issue with aep stimulation using ear inserts on mee-1000a-lt with serial# (b)(6).Service requested: assistance in troubleshooting.Service performed: customer reported issue with aep stimulation using the ear inserts.The left stimulated the right and the right stimulated the left.The left stimulus was coming out of the red box, and the right stimulus was coming out of the blue box.The ear inserts that provide aep (auditory evoked potentials) stimulation during mee-1000 procedure stimulated the incorrect sides.The issue was resolved by exchanging the ear inserts.The root cause of the issue was manufacturing defect by supplier etymotic research inc.The defect was identified by manufacturers before this issue was reported and the manufacturer had corrected the issue by exchanging the ear inserts, however customer was using old inserts due to which the ear inserts could not be replaced earlier.The issue was resolved.Review of device sap history found no previously reported issues with the unit.The warranty of the device expired on 05/13/2011.Investigation result(s): the root cause of the issue was manufacturing defect by supplier etymotic research inc.The defect was identified by manufacturers before this issue was reported and the manufacturer had corrected the issue by exchanging the ear inserts, however customer was using old inserts due to which the ear inserts could not be replaced earlier.The warranty of the device expired on 05/13/2011 according to product history of mee-1000a, one similar issue of aep stimulation using the ear inserts was reported by same customer (cleveland clinic health system) on 07/03/2019 in ticket# (b)(4).The root cause of the issue was manufacturing defect by supplier etymotic research inc.The defect was identified by manufacturers before this issue was reported and the manufacturer had corrected the issue by exchanging the ear inserts, however customer was using old inserts due to which the ear inserts could not be replaced earlier.The warranty of the device expired on 05/13/2011.The issue was resolved by providing an exchange of ear inserts to the customer.Corrective action: due to timely inaccessibility of the components provided by vendors resulting in delays for repair, as of december 26, 2016 nk, discontinued me-1000a and introduced mee-2000a as successor of me-1000a series.Support for the unit continued till the availability of parts of me-1000a.Investigation conclusion the root cause of the issue was manufacturing defect by supplier etymotic research inc.The defect was identified by manufacturers before this issue was reported and the manufacturer had corrected the issue by exchanging the ear inserts, however customer was using old inserts due to which the ear inserts could not be replaced earlier.The warranty of the device expired on 05/13/2011.
Event or Problem Description
The ear inserts that provide aep (auditory evoked potentials) stimulation during an mee-1000 procedure stimulated the incorrect sides.The mee-1000 pc system is used for evoked potentials, eegs, and emgs.These ear inserts had these issues years ago and the manufacturer of the ear inserts has since then corrected the issue.The customer had the old inserts that had these issues, and they were provided replacement inserts that are functioning correctly.

• 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, 161-8 560; JA 161-8560
• MDR Report Key: 7728204
• Report Number: 8030229-2018-00282
• Device Sequence Number: 11079987
• Product Code: GWF
• UDI-Device Identifier: 04931921102879
• UDI-Public: 04931921102879
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/13/2020
• Report Date (Section F): 01/13/2020

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
• Device Lot Number: NOT APPLICABLE
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/28/2018
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 01/08/2020
• Device Age: 0 MO
• Event Location: Hospital
• Date Report to Manufacturer: 01/13/2020
• Initial Date Received by Manufacturer: 07/27/2018
• Supplement Date Received by Manufacturer: 07/27/2018; 01/08/2020
• Initial Report FDA Received Date: 07/27/2018
• Supplement Report FDA Received Date: 03/12/2019; 01/13/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: NOT APPLICABLE
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: EAR INSERTS
• Date Report Sent to FDA: 01/13/2020