FDA Adverse Event
Malfunction
Summary report: N
STENOSCOP
MDR report key: 2101643
·
Received May 11, 2011
Report
- Report Number
- 9617766-2011-01027
- Event Type
- Malfunction
- Date Received
- May 11, 2011
- Date of Event
- February 2, 2011
- Report Date
- May 11, 2011
- Manufacturer
- GE MED SYSTEMS (INDIA) PRIVATE LTD
- Product Code
- JAA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FR
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
A GE SERVICE REPRESENTATIVE PERFORMED AN ONSITE INVESTIGATION. THE C-ARM CABLE WAS REPLACED. THE SYSTEM WAS TESTED AND FOUND TO BE WORKING AS INTENDED AND PUT BACK INTO SERVICE.
Description of Event or Problem · 1
THE CUSTOMER REPORTED THAT THE SYSTEM HAD POOR IMAGE QUALITY. NO PT INJURY WAS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | STENOSCOP | FLUOROSCOPIC X-RAY | JAA | GE MED SYSTEMS (INDIA) PRIVATE LTD | STENOSCOP |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |