FDA Adverse Event
Malfunction
Summary report: N
9800
MDR report key: 2042943
·
Received March 25, 2011
Report
- Report Number
- 1720753-2011-02837
- Event Type
- Malfunction
- Date Received
- March 25, 2011
- Date of Event
- February 28, 2011
- Report Date
- March 25, 2011
- Manufacturer
- GE OEC MEDICAL SYSTEMS (SLC)
- Product Code
- JAA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AL, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
A GE SERVICE REP PERFORMED AN ON SITE INVESTIGATION. THE 9800 SYSTEM X-RAY CONTROLLER BATTERY WAS REPLACED. THE NODES WERE ERASED AND REBUILT, FILAMENT CALIBRATION WAS PERFORMED, AND CALIBRATION AND CONFIGURATION FILES WERE LOADED. THE SYSTEM WAS TESTED AND OPERATES AS INTENDED.
Description of Event or Problem · 1
THE CUSTOMER REPORTED THE 9800 SYSTEM PRODUCED A LOW MASS ERROR MESSAGE DURING A CASE. 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 |