FDA Adverse Event
Malfunction
Summary report: N
9800
MDR report key: 2152702
·
Received June 24, 2011
Report
- Report Number
- 1720753-2011-08499
- Event Type
- Malfunction
- Date Received
- June 24, 2011
- Date of Event
- June 7, 2011
- Report Date
- June 24, 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 REPRESENTATIVE PERFORMED AN ONSITE INVESTIGATION. THE REPORTED ISSUE COULD NOT BE DUPLICATED. THE SERVICE REPRESENTATIVE RETRIEVED THE LOG FILES. THE SYSTEM WAS TESTED ADN FOUND TO BE WORKING AS INTENDED AND PUT BACK IN SERVICE.
Description of Event or Problem · 1
THE CUSTOMER REPORTED THAT THE SYSTEM WOULD EXTEND FLUOROSCOPIC X-RAY BEYOND DEMAND. 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 |