MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2018-05-25 for MEB-9400A manufactured by Nihon Kohden Corporation.
[109361247]
The doctor reported that there is inaccurate marking of onset latency when tested on sensory nerves and when tested on all motor nerves. They stated that this has resulted in an inaccurate diagnosis to a patient. We have attempted to contact the customer to inquire about the status of the patient, to further troubleshoot, and to provide additional training on the usage of the device. The customer was instructed to contact nka, but they have not responded back to us. 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
[109361248]
The doctor reported that there is inaccurate marking of onset latency when tested on sensory nerves and when tested on all motor nerves. They stated that this has resulted in an inaccurate diagnosis to a patient. We have attempted to contact the customer to inquire about the status of the patient to further troubleshoot, and to provide additional training on the usage of the device. The customer was instructed to contact nka, but they have not responded back to us.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8030229-2018-00173 |
| MDR Report Key | 7546759 |
| Report Source | USER FACILITY |
| Date Received | 2018-05-25 |
| Date of Report | 2018-05-25 |
| Date of Event | 2018-02-09 |
| Date Facility Aware | 2018-02-09 |
| Report Date | 2018-05-25 |
| Date Reported to FDA | 2018-05-25 |
| Date Reported to Mfgr | 2018-05-25 |
| Date Mfgr Received | 2018-05-25 |
| Device Manufacturer Date | 2017-12-12 |
| Date Added to Maude | 2018-05-25 |
| 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 | 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, GUNMA 370-2314 |
| Manufacturer Country | JA |
| Manufacturer Postal Code | 370-2314 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MEB-9400A |
| Generic Name | ELECTROMYOGRAPH |
| Product Code | IKN |
| Date Received | 2018-05-25 |
| Model Number | MEB-9400A |
| Catalog Number | MEB-9400A |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| Device Age | 4 MO |
| Device Eval'ed by Mfgr | * |
| 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 | 2018-05-25 |