FDA Adverse Event
Malfunction
Summary report: N
7900
MDR report key: 3013029
·
Received March 1, 2013
Report
- Report Number
- 9680959-2013-00446
- Event Type
- Malfunction
- Date Received
- March 1, 2013
- Date of Event
- February 12, 2013
- Report Date
- March 1, 2013
- Manufacturer
- GE OEC MEDICAL SYSTEMS GMBH
- Product Code
- JAA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FR
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
A GE SERVICE REP PERFORMED AN ON SITE INVESTIGATION. THE BATTERY AND IMAGE PROCESSOR WERE REPLACED DURING THE SERVICE CALL. THE SYSTEM WAS TESTED AND FOUND TO BE WORKING AS INTENDED AND PUT BACK INTO SERVICE.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE SYSTEM HAD INTERMITTENT CAMERA ERRORS AT BOOT UP. THE SYSTEM IS UNABLE TO DISPLAY FLUOROSCOPIC IMAGES. 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 |
|---|---|---|---|---|---|---|---|
| 90196 | 7900 | FLUOROSCOPIC X-RAY | JAA | GE OEC MEDICAL SYSTEMS GMBH | 7900 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |