FDA Adverse Event
Malfunction
Summary report: N
8800
MDR report key: 1910019
·
Received November 10, 2010
Report
- Report Number
- 9617766-2010-00731
- Event Type
- Malfunction
- Date Received
- November 10, 2010
- Date of Event
- August 25, 2010
- Report Date
- November 10, 2010
- Manufacturer
- GE MEDICAL SYSTEMS (INDIA) PRIVATE LTD
- Product Code
- JAA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GM
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
A GE REPRESENTATIVE EVALUATED THE SYSTEM AND REPLACED THE VIDEO CONTROLLER CARD. SYSTEM OPERATES AS INTENDED.
Description of Event or Problem · 1
CUSTOMER REPORTED THE VIDEO IMAGE IS OCCASIONALLY WHITE BUT CAN BE OPENED CORRECTLY AFTER THE UNIT IS SWITCHED ON AGAIN, AND IMAGES ARE OCCASIONALLY BRIGHT AFTER A FEW DAYS. NO PT INJURY WAS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | 8800 | FLUOROSCOPIC X-RAY | JAA | GE MEDICAL SYSTEMS (INDIA) PRIVATE LTD | 8800 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |