MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-11-18 for EEG-1200A manufactured by Nihon Kohden Tomioka Corporation.
[60690716]
The biomedical engineer reports that the device will note turn on and actually smoked at one point. Nihon kohden continues to investigate the reported event. Nihon kohden will submit a supplemental report in accordance with 21 cfr section 803. 56 when additional information becomes available.
Patient Sequence No: 1, Text Type: N, H10
[60690717]
The biomedical engineer reports that the device will note turn on and actually smoked at one point.
Patient Sequence No: 1, Text Type: D, B5
[68117905]
Manufacturer narrative: the biomedical engineer reported that the (b)(4) 9010 pc component of the eeg-1200a system would not power on and began to smoke. The computer was sent to nihon kohden for evaluation and repair, however damage to the computer's plastic cover, which is a part nihon kohden cannot order, prevented the repair of the computer. The customer was provided with a replacement computer. 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
| Report Number | 8030229-2016-00543 |
| MDR Report Key | 6111890 |
| Date Received | 2016-11-18 |
| Date of Report | 2016-10-18 |
| Date of Event | 2016-10-18 |
| Date Facility Aware | 2016-10-18 |
| Report Date | 2016-11-17 |
| Date Reported to FDA | 2016-11-17 |
| Date Reported to Mfgr | 2016-11-17 |
| Date Mfgr Received | 2016-11-17 |
| Date Added to Maude | 2016-11-18 |
| 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 | BIOMEDICAL ENGINEER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | SUSAN SHADLEY |
| Manufacturer Street | 1-31-4 NISHIOCHIAI, SHINJUKU-K ATTN: SUSAN SHADLEY |
| Manufacturer City | TOKYO, JAPAN 161-8560 |
| Manufacturer Country | JA |
| Manufacturer Postal | 161-8560 |
| Manufacturer Phone | 2687133 |
| Manufacturer G1 | NIHON KOHDEN TOMIOKA CORPORATION |
| Manufacturer Street | 1-1 TAJINO ATTN: SUSAN SHADLEY |
| Manufacturer City | TOMIOKA CITY, JAPAN 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 | 2016-11-18 |
| Returned To Mfg | 2016-10-20 |
| Model Number | EEG-1200A |
| Catalog Number | EEG-1200A |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | NIHON KOHDEN TOMIOKA CORPORATION |
| Manufacturer Address | 1-1 TAJINO ATTN: SUSAN SHADLEY TOMIOKA CITY, JAPAN 370-2314 JA 370-2314 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-11-18 |