FDA Adverse Event
Malfunction
Summary report: N
7900
MDR report key: 1944243
·
Received December 6, 2010
Report
- Report Number
- 9680959-2010-00561
- Event Type
- Malfunction
- Date Received
- December 6, 2010
- Date of Event
- November 17, 2010
- Report Date
- December 3, 2010
- 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 A BLOWN FUSE AND REPAIRED A PIN IN THE INTERCONNECT CABLE CONNECTOR. SYSTEM OPERATES AS INTENDED.
Description of Event or Problem · 1
THE CUSTOMER REPORTED THE MONITORS DO NOT WORK. NO PT INJURY WAS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | 7900 | FLUOROSCOPIC X-RAY | JAA | GE MED SYSTEMS (INDIA) PRIVATE LTD | 7900 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |