FDA Adverse Event
Malfunction
Summary report: N
9800
MDR report key: 3791722
·
Received January 21, 2014
Report
- Report Number
- 1720753-2014-00716
- Event Type
- Malfunction
- Date Received
- January 21, 2014
- Date of Event
- January 8, 2014
- Report Date
- January 21, 2014
- Manufacturer
- GE OEC MEDICAL SYSTEMS (SLC)
- Product Code
- JAA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FR
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
A GE REPRESENTATIVE EVALUATED THE SYSTEM BUT NO CONCLUSION CAN BE DRAWN AS FURTHER REPAIR INFORMATION IS NOT AVAILABLE.
Description of Event or Problem · 1
THE FE INDICATED THE SYSTEM DISPLAYED A CINE DISK ACCESS PROBLEM; THEREBY LOSING SUBTRACTION, ROAD-MAPPING, OR OTHER CRITICAL VASCULAR CINE FUNCTIONS. NO PT OR USER INJURY WAS REPORTED RELATED TO THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 51253 | 9800 | FLUOROSCOPIC X-RAY | JAA | GE OEC MEDICAL SYSTEMS (SLC) | 9800 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |