MAUDE Adverse Event Report: NIHON KOHDEN CORPORATION MEB-2300A; ELECTROMYOGRAPH

Model Number	MEB-2300A
Medical Device Problem Codes	Energy Output Problem (1431); Unintended Electrical Shock (4018); Intermittent Energy Output (4025)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/14/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The doctor reported that the stimulator for the meb electromyograph was intermittently discharging high voltage to the patient and was receiving a message to reset it each time.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 if additional information becomes available.Concomitant medical device.The following device was used in conjunction with the meb-2300a and is the device that failed: ry-230b stimulator probe (somato control box).S/n: ni.The udi#: (b)(4).Manufactured date: ni.Age of the device: ni.Device was not returned.
Event or Problem Description
The doctor reported that the stimulator for the meb electromyograph was intermittently discharging high voltage to the patient and was receiving a message to reset it each time.No patient harm was reported.
Event or Problem Description
The doctor reported that the stimulator for the meb electromyograph was intermittently discharging high voltage to the patient and was receiving a message to reset it each time.No patient harm wasreported.
Additional Manufacturer Narrative
Complaint information: on (b)(6) 2019, the customer at (b)(6) reported that the stimulator intermittently discharged high voltage to a patient and displayed a message to reset each time.Meb-2300a, serial#(b)(6).Service requested: part number request.Service performed: nk ts identified that the issue was caused by the ry-230b stim probe.Nk ts suggested replacing the probe to resolve the issue.Investigation summary: root cause of the issue was identified to be due to a defective probe.The meb unit cannot deliver a "higher voltage" as this is regulated and protected by the circuitry and software and cannot go beyond a certain voltage.The symptom was that the current was higher than what was normally felt.As a precautionary step, the electrical stimulus also has a fuse to prevent and excessive current from being delivered to the patient.It is also a pulsating dc current, not a continuous ac current, so there is minimal danger to the patient.According to the table in quality complaint investigations work instruction, with document id: sop07-018, the risk priority of the issue is categorized as: low.

• Brand Name: MEB-2300A
• Common Device Name: ELECTROMYOGRAPH
• 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: 9057736
• Report Number: 8030229-2019-00452
• Device Sequence Number: 16904602
• Product Code: IKN
• UDI-Device Identifier: 04931921102169
• UDI-Public: 04931921102169
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: K120397
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/06/2020
• Report Date (Section F): 09/13/2019

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: MEB-2300A
• Device Catalogue Number: MEB-2300A
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 08/14/2019
• Device Age: 67 MO
• Event Location: Hospital
• Date Report to Manufacturer: 09/13/2019
• Initial Date Received by Manufacturer: 08/14/2019
• Supplement Date Received by Manufacturer: 07/08/2020
• Initial Report FDA Received Date: 09/14/2019
• Supplement Report FDA Received Date: 11/06/2020
• 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: RY-230B STIMULATOR PROBE; RY-230B STIMULATOR PROBE
• Date Report Sent to FDA: 09/13/2019