FDA Adverse Event
Malfunction
Summary report: N
2800
MDR report key: 2041459
·
Received March 24, 2011
Report
- Report Number
- 1720753-2011-02726
- Event Type
- Malfunction
- Date Received
- March 24, 2011
- Date of Event
- March 15, 2011
- Report Date
- March 24, 2011
- Manufacturer
- GE OEC MEDICAL SYSTEMS (SLC)
- Product Code
- JAA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
A GE SERVICE REPRESENTATIVE PERFORMED AN ON SITE INVESTIGATION AND WAS UNABLE TO DUPLICATE THE PROBLEM. ERROR LOGS WERE CHECKED AND THE KILOVOLT CONTROLLER BOARD AND THE AUTOMATIC EXPOSURE CONTROL (AEC) PRINTED CIRCUIT BOARD WERE REPLACED. THE AEC CALIBRATION FILES WERE RELOADED TO THE 2800 SYSTEM. THE SYSTEM WAS TESTED AND OPERATES AS INTENDED.
Description of Event or Problem · 1
THE CUSTOMER REPORTED DURING FLUORO THE 2800 SYSTEM PRODUCED A GENERATOR FAILURE ERROR MESSAGE. NO PT INJURY WAS REPORTED.
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 |