FDA Adverse Event
Malfunction
Summary report: N
6800
MDR report key: 1002662
·
Received February 26, 2008
Report
- Report Number
- 1720753-2008-16391
- Event Type
- Malfunction
- Date Received
- February 26, 2008
- Date of Event
- February 15, 2008
- Report Date
- February 26, 2008
- Manufacturer
- GE OEC MEDICAL SYSTEMS INC.
- Product Code
- JAA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MA, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
A GE SERVICE REPRESENTATIVE PERFORMED AN ON SITE INVESTIGATION. THE REPORTED FAILURE COULD NOT BE DUPLICATED. BASED ON CASE REVIEW, ADVISED THE CUSTOMER TO USE THE SYSTEMS AUTO FEATURE FOR KVP. 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 THERE IS AN IMAGE QUALITY ISSUE ASSOCIATED WITH THE 6800 SYSTEM. IT WAS NOTED THAT WHEN TAKING IMAGES, THE SCREEN WHITES OUT AND YOU CAN NOT SEE THE IMAGE. THE CASE WAS COMPLETED AND THERE WAS NO REPORT OF PT INJURY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | 6800 | FLUOROSCOPIC X-RAY | JAA | GE OEC MEDICAL SYSTEMS INC. | 6800 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NI |