FDA Adverse Event
Malfunction
Summary report: N
9800
MDR report key: 2241229
·
Received August 18, 2011
Report
- Report Number
- 1720753-2011-21151
- Event Type
- Malfunction
- Date Received
- August 18, 2011
- Date of Event
- July 14, 2011
- Report Date
- August 18, 2011
- 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 SERVICE REP PERFORMED AN ONSITE INVESTIGATION. THE SERVICE REP CENTERED THE COLLIMATOR ON THE IMAGE INTENSIFIER. THE SYSTEM WAS TESTED AND FOUND TO BE WORKING AS INTENDED AND PUT BACK IN SERVICE.
Description of Event or Problem · 1
THE CUSTOMER REPORTED THAT THE SYSTEMS' X-RAY BEAM WAS NOT CENTERED ON THE IMAGE INTENSIFIER. 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 (SLC) | 9800 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |