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

Model Number	MEE-2000A
Medical Device Problem Codes	Electrical /Electronic Property Problem (1198); Failure to Deliver Energy (1211); Intermittent Shock/Stimulation (2287)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/19/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The stimulation pod is a part of the mee-2000a iom system, which is used for evoked potentials, eegs, and emgs.The stim cord was replaced to resolve the issue.No patient injury or 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 if additional information becomes available.The following device was being used in conjunction with the mee-2000a and was the one that experienced the malfunction.Concomitant medical product: stimulation pod.Model: jb-201b.Serial number (b)(4).
Event or Problem Description
The eeg tech reported that the jb-201b stimulation pod was delivering intermittent stimulus while connected to the mee-2000 during a procedure.
Event or Problem Description
The eeg tech reported that the jb-201b stimulation pod was delivering intermittent stimulus while connected to the mee-2000 during a procedure.
Additional Manufacturer Narrative
Details of complaint: the customer reported that a js-201b unit is delivering stimulus intermittently and changes when they move the cable.The customer requested a stim cord replacement.The device was returned to nka for repair and evaluation.No patient harm was reported.Service requested: exchange / repair / evaluation.Service performed: exchange / repair / evaluation: the unit was sent in for evaluation.During the evaluation of the device, it was revealed that the pins of the stimpod's internal cable were broken, and the internal cable needed to be replaced.Investigation summary: the overall risk of this event is "low." the root cause of this issue can be determined to be customer abuse as there was physical damage to the cable pins.Bent pins can come from mishandling the cable during seating.After evaluation, the nka repair center exchanged the internal cable.If the malfunction were to recur, it would not be likely to cause or contribute to patient harm.Based on sop07-003, no capa is required as the overall risk rating is low, and the quality event does not warrant a corrective action.The following fields are not applicable (na) to the mdr report: b2.B6.B7.D4 lot # & expiration date.D6a & d6b.D7b.F1 - f14.G4 device bla number.G5.G7.H7.H9.The following fields contain no information (ni), as attempts to obtain information were made, but not provided: a2 - a6.Additional device information: d10 concomitant medical device: the following device was used in conjunction with the stimulation box: stimulation pod: model #: js-201b.Serial #: (b)(6).Additional information: b4 date of this report.D9 device available for evaluation? g3 date received by manufacturer.G6 type of report.H2 if follow-up, what type? h3 device evaluated by manufacturer? h6 event problem and evaluation codes.H10 additional manufacturer narrative.

• Brand Name: MEE-2000A
• Common Device Name: EVOKED RESPONSE ELECTRIC STIMULATOR
• Manufacturer (Section D): NIHON KOHDEN CORPORATION; attn: shama mooman; 1-31-4 nishiochia; shinjuku-ku, tokyo 161-8 560; JA 161-8560
• MDR Report Key: 8800363
• Report Number: 8030229-2019-00301
• Device Sequence Number: 18888671
• Product Code: GWF
• UDI-Device Identifier: 00841983103629
• UDI-Public: 00841983103629
• Combination Product (Y/N): N
• Initial Reporter State: OK
• Initial Reporter Country: US
• PMA/510(K) Number: K142624
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/03/2021
• Report Date (Section F): 07/17/2019

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
• Device Catalogue Number: MEE-2000A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/17/2019
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 06/19/2019
• Device Age: 9 MO
• Event Location: Hospital
• Date Report to Manufacturer: 07/17/2019
• Initial Date Received by Manufacturer: 06/19/2019
• Supplement Date Received by Manufacturer: 06/24/2021
• Initial Report FDA Received Date: 07/17/2019
• Supplement Report FDA Received Date: 08/03/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: JB-201B; JB-201B
• Date Report Sent to FDA: 07/17/2019