FDA Adverse Event
Malfunction
Summary report: N
9800
MDR report key: 1071063
·
Received July 10, 2008
Report
- Report Number
- 1720753-2008-22761
- Event Type
- Malfunction
- Date Received
- July 10, 2008
- Date of Event
- June 12, 2008
- Report Date
- June 20, 2008
- Manufacturer
- GE OEC MEDICAL SYSTEMS INC.
- Product Code
- JAA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MA, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
CUSTOMER SHOWED GE SERVICE REP THE IMAGE SAVED THAT HAD PROBLEMS FROM A CASE. IT APPEARS THAT USING MAG FEATURE OF COLLIMATION WOULD HAVE IMPROVED QUALITY. THE REP TESTED ENTIRE UNIT TRACKING ALL NORMAL. LINE PAIR TOOLS ABOVE AVERAGE QUALITY. MAX DOES RATE AND KVP TRACKING ALL NORMAL. UNIT WORKING NORMALLY AT THIS TIME.
Description of Event or Problem · 1
THE CUSTOMER REPORTED THE IMAGES INTERMITTENTLY TURNS BLACK. 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 |