FDA Adverse Event
Malfunction
Summary report: N
9900
MDR report key: 1021742
·
Received March 19, 2008
Report
- Report Number
- 1720753-2008-19715
- Event Type
- Malfunction
- Date Received
- March 19, 2008
- Date of Event
- February 20, 2008
- Report Date
- March 18, 2008
- Manufacturer
- GE OEC MEDICAL SYSTEMS, INC.
- Product Code
- JAA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PA, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
THE SVC REP COULD NOT DUPLICATE FAILURE, RELOADED ALL SW, FLASHED NODES AND RELOADED, CAL FILES. HE CHECKED VOLTAGES IN THE WORKSTATION AND MAIN FRAME, ALL CHECKED WITHIN SPEC. THE REP VERIFIED THAT THE UNIT OPERATED AS INTENDED.
Description of Event or Problem · 1
CUSTOMER DESCRIBES FFB REBOOT AND DOUBLE IMAGE ON SUBTRACTION RUN. CUSTOMER WAS ABLE TO COMPLETE CASE WITH NO PROBLEMS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | 9900 | FLUOROSCOPIC X-RAY | JAA | GE OEC MEDICAL SYSTEMS, INC. | NA | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |