FDA Adverse Event
Malfunction
Summary report: N
9800
MDR report key: 1993201
·
Received February 7, 2011
Report
- Report Number
- 1720753-2011-01018
- Event Type
- Malfunction
- Date Received
- February 7, 2011
- Date of Event
- January 19, 2011
- Report Date
- February 7, 2011
- Manufacturer
- GE OEC MEDICAL SYSTEMS (SLC)
- Product Code
- JAA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NC, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
A GE SERVICE REPRESENTATIVE PERFORMED AN ON SITE INVESTIGATION. THE CAMERA AND 5 VOLT POWER SUPPLY WERE ADJUSTED AND THE INTERCONNECT CABLE WAS REPAIRED DURING THE SERVICE CALL. THE SYSTEM WAS TESTED AND FOUND TO BE WORKING AS INTENDED AND PUT BACK INTO SERVICE.
Description of Event or Problem · 1
THE CUSTOMER REPORTED THAT THE 9800 SYSTEM HAD DARK IMAGES AND THE TECHNIQUE TRACKED TO MAXIMUM OUTSIDE A CASE. NO PATIENT 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 |