FDA Adverse Event
Malfunction
Summary report: N
9800
MDR report key: 2031278
·
Received March 16, 2011
Report
- Report Number
- 1720753-2011-02385
- Event Type
- Malfunction
- Date Received
- March 16, 2011
- Date of Event
- February 23, 2011
- Report Date
- March 16, 2011
- Manufacturer
- GE OEC MEDICAL SYSTEMS (SLC)
- Product Code
- JAA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TN, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
A GE SERVICE REPRESENTATIVE PERFORMED AN ON SITE INVESTIGATION. THE CAMERA, PRINTER CIRCUIT BOARD, IMAGE PROCESSOR, CENTRAL PROCESSING UNIT, SMART POWER SWITCH, AND HARD DRIVE WERE ALL REPLACED. THE SOFTWARE WAS RELOADED AND THE CAMERA TESTED. THE SYSTEM OPERATES AS INTENDED.
Description of Event or Problem · 1
THE CUSTOMER REPORTED THE 9800 SYSTEM DISPLAYED BLACK IMAGES. NO PT INJURY WAS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | 9800 | FLUOROSCOPIC X-RAY | JAA | GE OEC MEDICAL SYSTEMS (SLC) | 9800 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |