FDA Adverse Event
Malfunction
Summary report: N
9800
MDR report key: 2891479
·
Received December 6, 2012
Report
- Report Number
- 1720753-2012-10177
- Event Type
- Malfunction
- Date Received
- December 6, 2012
- Date of Event
- November 27, 2012
- Report Date
- December 6, 2012
- Manufacturer
- GE OEC MEDICAL SYSTEMS (SLC)
- Product Code
- JAA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TN, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
A GE REPRESENTATIVE EVALUATED THE SYSTEM AND CLEANED AND RELUBRICATED THE HIGH VOLTAGE CANDLESTICK CONNECTORS. THE SYSTEM OPERATES AS INTENDED.
Description of Event or Problem · 1
THE CUSTOMER REPORTED THAT THE SYSTEM INTERMITTENTLY DISPLAYED A KV ON IN ERROR AND FILAMENT REGULATOR ERROR. IT IS A REASONABLE EXPECTATION THAT THE SYSTEM WAS NOT ABLE TO PROVIDE ENOUGH POWER TO CREATE EXCESSIVE RADIATION. THE "KV ON IN ERROR" ERROR MESSAGE WILL LIKELY SHUT THE SYSTEM DOWN. THERE WAS NO DEATH OR INJURY 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 |