FDA Adverse Event
Malfunction
Summary report: N
9800
MDR report key: 2994142
·
Received February 13, 2013
Report
- Report Number
- 1720753-2013-01744
- Event Type
- Malfunction
- Date Received
- February 13, 2013
- Date of Event
- December 4, 2012
- Report Date
- February 13, 2013
- 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 X-RAY TUBE WAS RECALIBRATED AND THE HIGH VOLTAGE TERMINALS WERE REGREASED, THE SYSTEM WAS THEN FOUND TO BE OPERATING AS INTENDED.
Description of Event or Problem · 1
THE FIELD ENGINEER REPORTED THAT THE SYSTEM DISPLAYED A "CONNECTION PROBLEM, PRESS ON THE EMERGENCY STOP" ERROR MESSAGE. THE ERROR WAS UNABLE TO BE BYPASSED AND THE SYSTEM WAS UNABLE TO PERFORM FLUOROSCOPY X-RAY. THERE IS NO REPORT OF PT INJURY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 63793 | 9800 | FLUOROSCOPIC X-RAY | JAA | GE OEC MEDICAL SYSTEMS (SLC) | 9800 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |