FDA Adverse Event
Malfunction
Summary report: N
2600
MDR report key: 2201140
·
Received July 29, 2011
Report
- Report Number
- 1720753-2011-20530
- Event Type
- Malfunction
- Date Received
- July 29, 2011
- Date of Event
- July 13, 2011
- Report Date
- July 29, 2011
- Manufacturer
- GE OEC MEDICAL SYSTEMS (SLC)
- Product Code
- JAA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- LA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
A GE SERVICE REP PERFORMED AN ONSITE INVESTIGATION. THE GENERATOR BATTERIES WERE REPLACED. THE SYSTEM WAS TESTED AND FOUND TO BE WORKING AS INTENDED AND PUT BACK INTO SERVICE.
Description of Event or Problem · 1
CUSTOMER REPORTED THAT THE SYSTEM WOULD DISPLAY AN X-RAY OVERTIME ERROR. THERE WAS NO PT INJURY REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | 2600 | FLUOROSCOPIC X-RAY | JAA | GE OEC MEDICAL SYSTEMS (SLC) | 2600 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |