MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2019-01-04 for MEB-9400A manufactured by Nihon Kohden Corporation.
[132513579]
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.
Patient Sequence No: 1, Text Type: N, H10
[132513580]
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.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8030229-2019-00001 |
| MDR Report Key | 8220327 |
| Report Source | USER FACILITY |
| Date Received | 2019-01-04 |
| Date of Report | 2019-11-06 |
| Date of Event | 2018-12-07 |
| Date Facility Aware | 2019-11-01 |
| Report Date | 2019-11-06 |
| Date Reported to FDA | 2019-11-06 |
| Date Reported to Mfgr | 2019-11-06 |
| Date Mfgr Received | 2019-11-01 |
| Device Manufacturer Date | 2013-06-05 |
| Date Added to Maude | 2019-01-04 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MS. SHAMA MOOMAN |
| Manufacturer Street | SAFETY MGMT DEPT, QUALITY MGMT SEIBU BLDG 2, 4TH FLOOR 1-11-2 |
| Manufacturer City | KUSUNOKIDAI TOKOROZAWA, SAITAMA 359-8580 |
| Manufacturer Country | JA |
| Manufacturer Postal | 359-8580 |
| Manufacturer G1 | NIHON KOHDEN TOMIOKA CORPORATION |
| Manufacturer Street | 1-1 TAJINO ATTN: SHAMA MOOMAN |
| Manufacturer City | TOMIOKA CITY, 370-2314 |
| Manufacturer Country | JA |
| Manufacturer Postal Code | 370-2314 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | NOT APPLICABLE |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MEB-9400A |
| Generic Name | ELECTROMYOGRAPH |
| Product Code | IKN |
| Date Received | 2019-01-04 |
| Model Number | MEB-9400A |
| Catalog Number | MEB-9400A |
| Lot Number | NOT APPLICABLE |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | 66 MO |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | NIHON KOHDEN CORPORATION |
| Manufacturer Address | 1-31-4 NISHIOCHIA, SHINJUKU-KU ATTN: SHAMA MOOMAN TOKYO, 161-8560 JA 161-8560 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-01-04 |