FDA Adverse Event
Malfunction
Summary report: N
GE OEC 9800
MDR report key: 879683
·
Received July 12, 2007
Report
- Report Number
- 1720753-2007-03312
- Event Type
- Malfunction
- Date Received
- July 12, 2007
- Date of Event
- June 20, 2007
- Report Date
- July 12, 2007
- Manufacturer
- GE OEC MEDICAL SYSTEMS INC.
- Product Code
- JAA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OH, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
A GE OEC SVC REP INVESTIGATED THE ISSUE AND FOUND A DEFECTIVE PS3 POWER SUPPLY THAT WAS REMOVED AND REPLACED. THE SYSTEM WAS TESTED AND FOUND TO BE OPERATING AS INTENDED. THE SYS WAS RELEASED TO THE CUSTOMER FOR USE. THE FACILITY WAS UNABLE TO, OR WOULD NOT PROVIDE ANY PT INFO WITH RESPECT TO THIS ISSUE. NO NEGATIVE PT EFFECT WAS REPORTED BECAUSE OF THIS MALFUNCTION.
Description of Event or Problem · 1
THE GE OEX 9900 FLUOROSCOPY SYSTEM HAD THE VERTICAL LIFT COLUMN FAIL TO OPERATE. VERTICAL LIFT COLUMN FAILURE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | GE OEC 9800 | FLUOROSCOPIC X-RAY | JAA | GE OEC MEDICAL SYSTEMS INC. | GE OEC 9800 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | YR |