MAUDE Adverse Event Report: NIHON KOHDEN CORPORATION MEE-2000A; EVOKED RESPONSE ELECTRIC STIMULATOR

Model Number	MEE-2000A-DT
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/05/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The customer reported that the frames of the cart for the mee-2000a system is collapsing and causing issues with the wheels not being aligned.The mee-2000a is an iom system which is used for evoked potentials, eegs, and emgs.Device not in use on patient and no patient harm 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 the frames of the cart for the mee-2000a system is collapsing and causing issues with the wheels not being aligned.The mee-2000a is an iom system which is used for evoked potentials, eegs, and emgs.Device not in use on patient and no patient harm reported.
Event or Problem Description
The customer reported that the frames of the cart for the mee-2000a system is collapsing and causing issues with the wheels not being aligned.The mee-2000a is an iom system which is used for evoked potentials, eegs, and emgs.Device not in use on patient and no patient harm reported.
Additional Manufacturer Narrative
Complaint details: on (b)(6) 2019 (b)(6) reported: continued issues with the frames collapsing causing wheel mal-alignment product id: mee-2000a-dt, serial# (b)(6) service requested/performed: exchange investigation result: issue resolved root cause: a scar (supplier corrective action) was sent to the supplier (b)(4) to resolve the issue of the wheels bowing and breaking off.The field use loads and requirements exceed those specified in the design requirements.Field conditions may include a higher load and or more aggressive use.Corrective action: (b)(4) agreed to a 3 phase approach.1- washer retrofit kit, 2- field upgrade kit and 3- redesign.Nka agreed to all three.1- washer retrofit kit nih 9600 were developed and shipped.(b)(4).2- upgrade kit was developed for field upgrades.This kit included a new design for the base.Included on (b)(4).3- nka agreed to redesign.Redesign was completed.See (b)(4).The eco was approved by nka.Change will be implemented on the open order.Validation: for the months of (b)(6) 2019 after the hardware kit was implemented at (b)(6) on brand new carts, there have been no complaints on the carts and are working as they should.We received the upgraded carts from (b)(4) as of january 2019 with the eco change is implemented.So, going forward, the carts shipped will have the upgraded design.The device was not in use on a patient and there was no reported harm.As such, there is no risk to using this device or remaining devices on the market for this issue.Based on the given information, this complaint record can be closed as no further investigation is needed at this time.Corrected information: f9.Approximate age of device: incorrectly calcuated.

• Brand Name: MEE-2000A
• 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: 8741369
• Report Number: 8030229-2019-00248
• Device Sequence Number: 1489856
• Product Code: GWF
• UDI-Device Identifier: 00841983103612
• UDI-Public: 00841983103612
• Combination Product (Y/N): N
• Initial Reporter State: WV
• Initial Reporter Country: US
• PMA/510(K) Number: K142624
• 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): 08/29/2019
• Report Date (Section F): 08/29/2019

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: MEE-2000A-DT
• Device Catalogue Number: MEE-2000A-DT
• Device Lot Number: NOT APPLICABLE
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 06/14/2019
• Device Age: 35 MO
• Event Location: Hospital
• Date Report to Manufacturer: 08/29/2019
• Initial Date Received by Manufacturer: 06/05/2019
• Supplement Date Received by Manufacturer: 06/14/2019
• Initial Report FDA Received Date: 06/27/2019
• Supplement Report FDA Received Date: 08/29/2019
• 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
• Date Report Sent to FDA: 08/29/2019