MAUDE Adverse Event Report: NIHON KOHDEN CORPORATION MEB-9400A; ELECTROMYOGRAPH

Model Number	MEB-9400A
Medical Device Problem Codes	Temperature Problem (3022); Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/07/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The customer reported that there was a burning smell from the power supply from their meb-9400a system after it had shutdown.They got it running for a little while in safe mode and would like the system evaluated.However, they have ordered a replacement and are awaiting its arrival before taking this unit offline.The caller and their it person expressed they wanted to keep the system in use after i explained the system may be a hazard to the patients.No patient harm or injury 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.
Event or Problem Description
The customer reported that there was a burning smell from the power supply from their meb-9400a system after it had shutdown.They got it running for a little while in safe mode and would like the system evaluated.However, they have ordered a replacement and are awaiting its arrival before taking this unit offline.The caller and their it person expressed they wanted to keep the system in use after i explained the system may be a hazard to the patients.No patient harm or injury reported.
Event or Problem Description
The customer reported that there was a burning smell from the power supply from their meb-9400a system after it had shutdown.They got it running for a little while in safe mode and would like the system evaluated.However, they have ordered a replacement and are awaiting its arrival before taking this unit offline.The caller and their it person expressed they wanted to keep the system in use after i explained the system may be a hazard to the patients.No patient harm or injury reported.
Additional Manufacturer Narrative
Complaint details: the customer reported on (b)(6) 2018 that they were getting burning smell from power supply.The system had shut down.The customer got it running for a little while in safe mode but wanted it to be checked out.Service requested: the customer requested the device to be evaluated service provided: the customer did not send in the unit for repair/evaluation investigation result: the unit was placed into service on (b)(6) 2017, which is over 1 year at the time of the reported issue.A review of device history found no previously reported similar issue with this device.Similar tickets using "meb 9400a burning smell power supply" and gave no result.Review of tickets reported by the neurological medicine found no similar reported issue.Based on the device service history, complaints from customer site and similar search query, no adverse trend is suspected with the device.The root cause of the issue was unable to be determined due to limited information in the complaint record and the device was not returned to nk for repair/evaluation.The customer was informed about the hazard that can occur to the patients.The device was being used by the customer.No further complaint was reported with the device.Corrected information: f9.Approximate age of device: incorrectly calcuated g4.Date received by manufacturer: should be (b)(6) 2018 not (b)(6) 2019 as listed on mdr initial report.

• Brand Name: MEB-9400A
• 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: 8220327
• Report Number: 8030229-2019-00001
• Device Sequence Number: 16558232
• Product Code: IKN
• UDI-Device Identifier: 04931921102183
• UDI-Public: 04931921102183
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• PMA/510(K) Number: K010590
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/06/2019
• Report Date (Section F): 11/06/2019

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-9400A
• Device Catalogue Number: MEB-9400A
• Device Lot Number: NOT APPLICABLE
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 11/01/2019
• Device Age: 66 MO
• Event Location: Hospital
• Date Report to Manufacturer: 11/06/2019
• Initial Date Received by Manufacturer: 01/03/2019
• Supplement Date Received by Manufacturer: 11/01/2019
• Initial Report FDA Received Date: 01/04/2019
• Supplement Report FDA Received Date: 11/06/2019
• 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: 11/06/2019