MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1996-12-23 for NOHON KOHDEN, EEG 4317B * manufactured by Nihon Kohden America, Inc..
[40235]
Pt was scheduled for outpatient eeg. Sedation had been given. Pt was attached to machine. Tech attempted to calibrate machine. Unable to calibrate. Unable to do eeg. Will have to reschedule test.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 58818 |
| MDR Report Key | 58818 |
| Date Received | 1996-12-23 |
| Date of Report | 1996-12-20 |
| Date of Event | 1996-12-20 |
| Date Facility Aware | 1996-12-20 |
| Report Date | 1996-12-20 |
| Date Reported to FDA | 1996-12-23 |
| Date Reported to Mfgr | 1996-12-23 |
| Date Added to Maude | 1996-12-31 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | NOHON KOHDEN, EEG |
| Generic Name | EEG MACHINE |
| Product Code | GWS |
| Date Received | 1996-12-23 |
| Model Number | 4317B |
| Catalog Number | * |
| Lot Number | * |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | 10 YR |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 59256 |
| Manufacturer | NIHON KOHDEN AMERICA, INC. |
| Manufacturer Address | 2601 CAMPUS DR IRVINE CA 927151601 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 1996-12-23 |