FDA Adverse Event
Malfunction
Summary report: N
9800
MDR report key: 2040367
·
Received February 15, 2011
Report
- Report Number
- 1720753-2011-02251
- Event Type
- Malfunction
- Date Received
- February 15, 2011
- Date of Event
- February 18, 2011
- Report Date
- March 15, 2011
- Manufacturer
- GE OEC MEDICAL SYSTEMS (SLC)
- Product Code
- JAA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AZ, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
THE GE REPRESENTATIVE CONDUCTED AN ON SITE INVESTIGATION. THE VIDEO CONTROL AND DISPLAY ADAPTER PRINTED CIRCUIT BOARDS WERE RESEATED. THE SYSTEM WAS TESTED AND IS NOW OPERATING AS INTENDED.
Description of Event or Problem · 1
THE CUSTOMER REPORTED THAT THE FLUORO ON THE 9800 SYSTEM WOULD NOT ADJUST AND THAT THE LEFT SCREEN WAS VERY DARK. NO PT INJURY WAS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | 9800 | FLUOROSCOPIC X-RAY | JAA | GE OEC MEDICAL SYSTEMS (SLC) | 9800 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |