FDA Adverse Event
Malfunction
Summary report: N
9900
MDR report key: 1820037
·
Received August 23, 2010
Report
- Report Number
- 1720753-2010-02727
- Event Type
- Malfunction
- Date Received
- August 23, 2010
- Date of Event
- August 3, 2010
- Report Date
- August 23, 2010
- 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 REPRESENTATIVE EVALUATED THE SYSTEM AND REMOVED AND REPLACED THE HARD DRIVE, LOADED VERSION (B)(4) SOFTWARE, AND THE CONFIGURATION AND CALIBRATION FILES. SYSTEM OPERATES AS INTENDED.
Description of Event or Problem · 1
UNIT IS INTERMITTENTLY DISPLAYING A FILE SYSTEM CORRUPTION DETECTED MESSAGE AND LOCKS UP DURING CASES. 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 |