FDA Adverse Event
Malfunction
Summary report: N
8800
MDR report key: 2934254
·
Received January 7, 2013
Report
- Report Number
- 1720753-2013-00260
- Event Type
- Malfunction
- Date Received
- January 7, 2013
- Date of Event
- December 12, 2012
- Report Date
- January 7, 2013
- Manufacturer
- GE OEC MEDICAL SYSTEMS (SLC)
- Product Code
- JAA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
A GE REPRESENTATIVE EVALUATED THE SYSTEM AND REPLACED THE MONOBLOCK X-RAY TUBE ASSEMBLY. THE SYSTEM OPERATES AS INTENDED.
Description of Event or Problem · 1
THE CUSTOMER REPORTED THE SYSTEM DISPLAYED A "GENERATOR ERROR". THIS ERROR IS LIKELY TO RESULT IN AN UN-COMMANDED LOSS OF SYSTEM FUNCTIONALITY AND REQUIRE A SYSTEM REBOOT. THERE IS NO REPORT OF PT INJURY OR DEATH.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 8533 | 8800 | FLUOROSCOPIC X-RAY | JAA | GE OEC MEDICAL SYSTEMS (SLC) | 8800 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |