FDA Adverse Event
Malfunction
Summary report: N
9900
MDR report key: 2040364
·
Received February 15, 2011
Report
- Report Number
- 1720753-2011-02265
- Event Type
- Malfunction
- Date Received
- February 15, 2011
- Date of Event
- February 18, 2011
- Report Date
- March 15, 2011
- Manufacturer
- GE OEC MEDICAL SYSTEMS (SLC)
- Product Code
- JAA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NC, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
A GE SERVICE REPRESENTATIVE PERFORMED AN ON SITE INVESTIGATION. THE SOFTWARE AND SYSTEM CALIBRATION FILES WERE RELOADED. THE SYSTEM OPERATES AS INTENDED.
Description of Event or Problem · 1
THE CUSTOMER REPORTED THE SYSTEM WAS NOT COMPLETING THE BOOT UP PROCESS AND HAD FILE CHECK ERRORS. NO PT INJURY WAS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | 9900 | FLUOROSCOPIC X-RAY | JAA | GE OEC MEDICAL SYSTEMS (SLC) | 9900 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |