FDA Adverse Event
Malfunction
Summary report: N
9800 12
MDR report key: 2058510
·
Received April 7, 2011
Report
- Report Number
- 1720753-2011-03348
- Event Type
- Malfunction
- Date Received
- April 7, 2011
- Date of Event
- January 5, 2011
- Report Date
- April 7, 2011
- Manufacturer
- GE OEC MEDICAL SYSTEMS (SLC)
- Product Code
- JAA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FR
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
A GE SERVICE REP PERFORMED AN ON SITE INVESTIGATION AND WAS UNABLE TO DUPLICATE THE PROBLEM. POOR CONNECTIONS IN THE MAIN'S POWER SOCKET WERE LOCATED. THE SYSTEM WAS TESTED AND OPERATES AS INTENDED.
Description of Event or Problem · 1
THE CUSTOMER REPORTED THERE WAS A PROBLEM WITH IMAGES BEING SUPERIMPOSED AND INVERTED, POSSIBLY ATTRIBUTED TO A PEDAL PROBLEM. NO PT INJURY WAS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | 9800 12 | FLUOROSCOPIC X-RAY | JAA | GE OEC MEDICAL SYSTEMS (SLC) | 9800 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |