FDA Adverse Event
Malfunction
Summary report: N
9900
MDR report key: 2896849
·
Received December 28, 2012
Report
- Report Number
- 1720753-2012-10858
- Event Type
- Malfunction
- Date Received
- December 28, 2012
- Date of Event
- December 10, 2012
- Report Date
- December 28, 2012
- Manufacturer
- GE OEC MEDICAL SYSTEMS (SLC)
- 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 SOFTWARE UPGRADE WAS INSTALLED 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
THE CUSTOMER REPORTED THAT THERE WAS A MESSAGE OF "NO SERVICE"; THEY NEEDED TO RESTART AND THAT THE FAULT WAS PREVENTING WORK. THIS COULD CAUSE AN INTERMITTENT LOSS OF SYSTEM FUNCTIONALITY. THERE IS NO REPORT OF PT INJURY OR DEATH.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | 9900 | FLUOROSCOPIC X-RAY | JAA | GE OEC MEDICAL SYSTEMS (SLC) | 9900 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |