FDA Adverse Event
Malfunction
Summary report: N
2800
MDR report key: 2090556
·
Received April 26, 2011
Report
- Report Number
- 1720753-2011-06522
- Event Type
- Malfunction
- Date Received
- April 26, 2011
- Date of Event
- April 4, 2011
- Report Date
- April 26, 2011
- Manufacturer
- GE OEC MEDICAL SYSTEMS (SLC)
- Product Code
- JAA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
A GE SERVICE REPRESENTATIVE PERFORMED AN ON SITE INVESTIGATION. THE WORKSTATION AND CPU POWER SUPPLY VOLTAGES WERE CHECKED AND BOTH VIDEO MONITORS WERE REPLACED. THE CELERON SINGLE BOARD COMPUTER AND THE HARD DISK DRIVE WERE REPLACED AND THE SOFTWARE WAS RELOADED. THE SYSTEM WAS TESTED AND OPERATES AS INTENDED.
Description of Event or Problem · 1
THE CUSTOMER REPORTED THAT THE 2800 SYSTEM MONITORS WERE NOT WORKING CORRECTLY AND INTERMITTENTLY DISPLAYED "GHOST IMAGES."
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | 2800 | FLUOROSCOPIC X-RAY | JAA | GE OEC MEDICAL SYSTEMS (SLC) | 2800 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |