FDA Adverse Event
Malfunction
Summary report: N
2800
MDR report key: 2960630
·
Received January 25, 2013
Report
- Report Number
- 1720753-2013-01097
- Event Type
- Malfunction
- Date Received
- January 25, 2013
- Date of Event
- January 2, 2013
- Report Date
- January 25, 2013
- Manufacturer
- GE OEC MEDICAL SYSTEMS (SLC)
- Product Code
- JAA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
A GE REPRESENTATIVE EVALUATED THE SYSTEM AND REPLACED MISSING GROUND SCREWS, THE POWER SWITCH, THE LOW VOLTAGE POWER SWITCH, AND THE KV CONTROL BOARD. THE SYSTEM OPERATES AS INTENDED.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE SYSTEM HAD A "GENERATOR ERROR." WHEN THE SYSTEM HAS THIS ERROR, THE SYSTEM AUTOMATICALLY SHUTS DOWN, PREVENTING OPERATION. THERE IS NO REPORT OF INJURY OR DEATH ASSOCIATED WITH THE EVENT DESCRIBED IN THIS COMPLAINT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 35340 | 2800 | FLUOROSCOPIC X-RAY | JAA | GE OEC MEDICAL SYSTEMS (SLC) | 2800 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |