FDA Adverse Event
Malfunction
Summary report: N
9900
MDR report key: 2900974
·
Received December 13, 2012
Report
- Report Number
- 1720753-2012-10406
- Event Type
- Malfunction
- Date Received
- December 13, 2012
- Date of Event
- November 30, 2012
- Report Date
- December 13, 2012
- Manufacturer
- GE OEC MEDICAL SYSTEMS (SLC)
- Product Code
- JAA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MI, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
A GE REPRESENTATIVE EVALUATED THE SYSTEM AND RESEATED THE FUSES. THE SYSTEM OPERATES AS INTENDED.
Description of Event or Problem · 1
THE FSE REPORTED THAT THE SYSTEM DISPLAYED, "COMMUNICATION ERROR." THIS ERROR MAY RESULT IN A SYSTEM LOCK UP, NO BOOT, OR SHUT DOWN SITUATION DEPENDING ON WHEN THE LOSS OF COMMUNICATION OCCURRED. 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 |
|---|---|---|---|---|---|---|---|
| 1 | 9900 | FLUOROSCOPIC X-RAY | JAA | GE OEC MEDICAL SYSTEMS (SLC) | 9900 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |