FDA Adverse Event
Malfunction
Summary report: N
9800
MDR report key: 1002742
·
Received February 26, 2008
Report
- Report Number
- 1720753-2008-16410
- Event Type
- Malfunction
- Date Received
- February 26, 2008
- Date of Event
- February 19, 2008
- Report Date
- February 26, 2008
- Manufacturer
- GE OEC MEDICAL SYSTEMS INC
- Product Code
- JAA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
A GE SERVICE REPRESENTATIVE PERFORMED AN ON SITE INVESTIGATION. THE MALFUNCTION WAS VERIFIED. REPLACED THE DISPLAY ADAPTER, IMAGE PROCESSOR, GENERATOR INTERFACE PCB, FLUORO FUNCTION BOARD PCB AND THE SNUBBER PCB. 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 LEFT MONITOR ON THE 9800 SYSTEM WENT BLACK DURING THE CASE. 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 | UNK |