FDA Adverse Event
Malfunction
Summary report: N
LIGHT SPEED 16 SLICE
MDR report key: 3983226
·
Received July 8, 2014
Report
- Report Number
- 3983226
- Event Type
- Malfunction
- Date Received
- July 8, 2014
- Date of Event
- June 29, 2014
- Report Date
- July 8, 2014
- Manufacturer
- GE HEALTHCARE
- Product Code
- JAK
- Product Problem
- Yes
- Report Source
- User Facility report
- Reporter Location
- FL, US
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 398522 | LIGHT SPEED 16 SLICE | SYSTEM, X-RAY, TOMOGRAPHY | JAK | GE HEALTHCARE | * | * |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 53 YR |