FDA Adverse Event
Malfunction
Summary report: N
9900
MDR report key: 4090048
·
Received August 18, 2014
Report
- Report Number
- 1720753-2014-07049
- Event Type
- Malfunction
- Date Received
- August 18, 2014
- Date of Event
- July 23, 2014
- Report Date
- August 18, 2014
- Manufacturer
- GE OEC MEDICAL SYSTEMS (SLC)
- Product Code
- JAA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GM
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
A GE SERVICE REP PERFORMED AN ONSITE INVESTIGATION. NO CONCLUSION CAN BE DRAWN AS REPAIR INFO IS AVAILABLE.
Description of Event or Problem · 1
THE CUSTOMER REPORTED AN ERROR WITH THE CONTROL CONSOLE. THE FE CONFIRMED THE SYSTEM WAS UNABLE TO PERFORM FLUOROSCOPY OR BOOT UP. THERE IS NO REPORT OF INJURY OR DEATH ASSOCIATED WITH THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 496316 | 9900 | FLUOROSCOPIC X-RAY | JAA | GE OEC MEDICAL SYSTEMS (SLC) | 9900 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |