FDA Adverse Event
Malfunction
Summary report: N
9800
MDR report key: 1000861
·
Received February 21, 2008
Report
- Report Number
- 1720753-2008-16277
- Event Type
- Malfunction
- Date Received
- February 21, 2008
- Date of Event
- February 12, 2008
- Report Date
- February 20, 2008
- Manufacturer
- GE OEC MEDICAL SYSTEMS INC
- Product Code
- JAA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- WV, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
A GE SERVICE REP PERFORMED AN ON SITE INVESTIGATION. THE MALFUNCTION WAS VERIFIED. CLEANED AND REGREASED THE ANODE CONNECTOR, REPLACED THE SNUBBER BOARD AND VIDEO CAMERA. 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 9800 SYSTEM PRESENTED ERRORS AND NO IMAGE ON THE C-ARM DURING A CASE. THE CASE WAS COMPLETED USING ANOTHER SYSTEM. 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 |