FDA Adverse Event
Malfunction
Summary report: N
7900
MDR report key: 2934673
·
Received January 4, 2013
Report
- Report Number
- 9680959-2013-00041
- Event Type
- Malfunction
- Date Received
- January 4, 2013
- Date of Event
- December 18, 2012
- Report Date
- January 4, 2013
- Manufacturer
- GE OEC MEDICAL SYSTEMS GMBH
- Product Code
- JAA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SZ
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
A GE REPRESENTATIVE EVALUATED THE SYSTEM AND REPLACED THE IMAGE PROCESSING COMPUTER. THE SYSTEM OPERATES AS INTENDED.
Description of Event or Problem · 1
IT WAS REPORTED THAT, DURING AN EXAMINATION, THE SYSTEM STOPPED AND DISPLAYED AN ERROR CODE ON THE MONITOR. HOWEVER, THE CUSTOMER WAS ABLE TO RESTART THE SYSTEM AND FINISH THE EXAMINATION. THERE IS NO REPORT OF PATIENT INJURY OR DEATH.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 5573 | 7900 | FLUOROSCOPIC X-RAY | JAA | GE OEC MEDICAL SYSTEMS GMBH | 7900 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |