FDA Adverse Event
Malfunction
Summary report: N
9800
MDR report key: 1021765
·
Received March 19, 2008
Report
- Report Number
- 1720753-2008-19792
- Event Type
- Malfunction
- Date Received
- March 19, 2008
- Date of Event
- March 10, 2008
- Report Date
- March 18, 2008
- Manufacturer
- GE OEC MEDICAL SYSTEMS INC.
- Product Code
- JAA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
A GE SERVICE REP PERFORMED AN ON SITE INVESTIGATION. ADJUSTED THE 5V POWER SUPPLY IN BOTH THE MAINFRAME AND WORKSTATION. TIGHTENED THE TRANSFORMER LUGS. THE SYSTEM WAS TESTED AND FOUND TO BE WORKING AS INTENDED AND PLACED BACK INTO SERVICE.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE 9800 SYSTEM, AFTER FLUORO, WILL CONTINUE TO FLUORO BEFORE STOPPING. IT WAS NOTED THAT THIS STARTED INTERMITTENTLY ABOUT ONE WEEK AGO. THERE WAS NO REPORT OF PT INJURY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | 9800 | FLUOROSCOPIC X-RAY | JAA | GE OEC MEDICAL SYSTEMS INC. | 9800 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |