FDA Adverse Event
Malfunction
Summary report: N
9800
MDR report key: 3172150
·
Received June 11, 2013
Report
- Report Number
- 1720753-2013-06965
- Event Type
- Malfunction
- Date Received
- June 11, 2013
- Date of Event
- May 21, 2013
- Report Date
- June 11, 2013
- Manufacturer
- GE OEC MEDICAL SYSTEMS (SLC)
- Product Code
- JAA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
A GE REPRESENTATIVE EVALUATED THE SYSTEM AND REPLACED THE CONTROL PANEL PROCESSOR AND CONTROL PANEL PROCESSOR I/O BOARDS. THE SYSTEM OPERATES AS INTENDED.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE SYSTEM LOCKED UP. NO PT INJURY WAS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 263995 | 9800 | FLUOROSCOPIC X-RAY | JAA | GE OEC MEDICAL SYSTEMS (SLC) | 9800 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |