MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2017-12-06 for EEG-1200A manufactured by Nihon Kohden Corporation.
[94492408]
The eeg tech reported the eeg / psg combo system "popped and started smelling like something was burnt. " qa along with service reviewed the pc and the computer would not turn on, only the amber light was flashing. There was not burning smell. The unit was then evaluated by the service, and they concluded that the power supply was bad. The power supply was replaced and the unit was burned-in for 72 hours and everything tested fine. 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
[94492409]
The eeg tech reported the eeg / psg combo system "popped and started smelling like something was burnt. "
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8030229-2017-00424 |
| MDR Report Key | 7087049 |
| Report Source | USER FACILITY |
| Date Received | 2017-12-06 |
| Date of Report | 2017-12-06 |
| Date of Event | 2017-11-07 |
| Date Facility Aware | 2017-11-07 |
| Report Date | 2017-12-06 |
| Date Reported to FDA | 2017-12-06 |
| Date Reported to Mfgr | 2017-12-06 |
| Date Mfgr Received | 2017-12-06 |
| Device Manufacturer Date | 2013-08-22 |
| Date Added to Maude | 2017-12-06 |
| 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 |
| Reporter Occupation | MEDICAL TECHNOLOGIST |
| 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 | EEG-1200A |
| Generic Name | NEUROFAX ELECTROENCEPHALOGRAPH |
| Product Code | OLT |
| Date Received | 2017-12-06 |
| Returned To Mfg | 2017-11-28 |
| Model Number | EEG-1200A |
| Catalog Number | EEG-1200A |
| Operator | MEDICAL TECHNOLOGIST |
| Device Availability | R |
| Device Age | 51 MO |
| Device Eval'ed by Mfgr | Y |
| 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 | 2017-12-06 |