FDA Adverse Event
Malfunction
Summary report: N
9800
MDR report key: 2251411
·
Received September 9, 2011
Report
- Report Number
- 1720753-2011-21790
- Event Type
- Malfunction
- Date Received
- September 9, 2011
- Date of Event
- August 30, 2011
- Report Date
- September 9, 2011
- Manufacturer
- GE OEC MEDICAL SYSTEMS (SLC)
- Product Code
- JAA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MS, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
A GE SERVICE REPRESENTATIVE PERFORMED AN ONSITE INVESTIGATION. THE SERVICE REPRESENTATIVE VERIFIED THE IMAGE INTENSIFIER WAS FUNCTIONAL. 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 FLUOROSCOPIC GRID HAS FALLEN OFF OF THE TOWER AND THE LASER LIGHT ALSO FAILED DURING USE. 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 |