FDA Adverse Event
Malfunction
Summary report: N
8800
MDR report key: 1981462
·
Received February 1, 2011
Report
- Report Number
- 9617766-2011-00214
- Event Type
- Malfunction
- Date Received
- February 1, 2011
- Date of Event
- January 13, 2011
- Report Date
- February 1, 2011
- Manufacturer
- GE MED SYSTEMS (INDIA) PRIVATE LTD
- Product Code
- JAA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AS
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
A GE REPRESENTATIVE EVALUATED THE SYSTEM AND REPLACED THE INTERCONNECT CABLE. SYSTEM OPERATES AS INTENDED.
Description of Event or Problem · 1
CUSTOMER REPORTED THE SYSTEM DISPLAYS A MESSAGE STATING SYSTEM NEEDS TO BE REBOOTED, BUT IS STILL BEING DISPLAYED AFTER REBOOT. NO PT INJURY WAS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | 8800 | FLUOROSCOPIC X-RAY | JAA | GE MED SYSTEMS (INDIA) PRIVATE LTD | 8800 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |