FDA Adverse Event
Malfunction
Summary report: N
9900
MDR report key: 3060323
·
Received April 11, 2013
Report
- Report Number
- 1720753-2013-04892
- Event Type
- Malfunction
- Date Received
- April 11, 2013
- Date of Event
- April 2, 2013
- Report Date
- April 11, 2013
- Manufacturer
- GE OEC MEDICAL SYSTEMS (SLC)
- Product Code
- JAA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
A GE REPRESENTATIVE EVALUATED THE SYSTEM AND RELOADED SOFTWARE. THE SYSTEM OPERATES AS INTENDED.
Description of Event or Problem · 1
THE FSE REPORTED A FILE CORRUPTION ERROR. THIS ERROR CAUSES THE SYSTEM TO LOCK UP OR NOT TO BOOT. THERE IS NO REPORT OF INJURY OR DEATH ASSOCIATED WITH THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 154485 | 9900 | FLUOROSCOPIC X-RAY | JAA | GE OEC MEDICAL SYSTEMS (SLC) | 9900 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |