FDA Adverse Event
Malfunction
Summary report: N
8800
MDR report key: 3791711
·
Received January 21, 2014
Report
- Report Number
- 1720753-2014-00734
- Event Type
- Malfunction
- Date Received
- January 21, 2014
- Date of Event
- December 30, 2013
- Report Date
- January 21, 2014
- Manufacturer
- GE OEC MEDICAL SYSTEMS (SLC)
- Product Code
- JAA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CO, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
A GE REP EVALUATED THE SYSTEM BUT NO CONCLUSION CAN BE DRAWN AS FURTHER REPAIR INFO IS NOT AVAILABLE AT THIS TIME.
Description of Event or Problem · 1
THE CUSTOMER REPORTED THAT THE SYSTEM DISPLAYED A GENERATOR ERROR MESSAGE, AND THAT THERE WAS ARCING. THIS MESSAGE LIKELY RESULTED IN A SYSTEM SHUT DOWN SITUATION. THERE ARE NO REPORTS OF PT INJURY OR DEATH ASSOCIATED WITH THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 51018 | 8800 | FLUOROSCOPIC X-RAY | JAA | GE OEC MEDICAL SYSTEMS (SLC) | 8800 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |