FDA Adverse Event
Malfunction
Summary report: N
9800
MDR report key: 1071143
·
Received July 10, 2008
Report
- Report Number
- 1720753-2008-22940
- Event Type
- Malfunction
- Date Received
- July 10, 2008
- Date of Event
- June 13, 2008
- Report Date
- June 26, 2008
- Manufacturer
- GE OEC MEDICAL SYSTEMS INC.
- Product Code
- JAA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NJ, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
THE GE SERVICE REP INSTALLED SBC KIT AND RELOADED SOFTWARE. HE VERIFIED PROPER OPERATION OF SYSTEM. UNIT IS FUNCTIONAL AND OPERATES AS INTENDED. OLD IMAGES ON HARD DRIVE WERE LOST DURING SOFTWARE INSTALL.
Description of Event or Problem · 1
THE CUSTOMER REPORTED THE SYSTEM DOES NOT ALWAYS BOOT UP. ALSO, THE SYSTEM DISPLAYED A BLANK SCREEN. 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 INC. | NA | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |