FDA Adverse Event
Malfunction
Summary report: N
STENOSCOP
MDR report key: 2102194
·
Received May 19, 2011
Report
- Report Number
- 9617766-2011-01087
- Event Type
- Malfunction
- Date Received
- May 19, 2011
- Date of Event
- February 11, 2011
- Report Date
- May 19, 2011
- Manufacturer
- GE MEDICAL SYSTEMS (INDIA) PRIVATE, LTD. (GE PRIVATE)
- Product Code
- JAA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SP
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
NO CONCLUSIONS CAN BE DRAWN AS REPAIR INFO IS UNAVAILABLE AND NO ADD'L SERVICE INFO WAS PROVIDED.
Description of Event or Problem · 1
THE CUSTOMER REPORTED THAT THE SYSTEM'S CONNECTOR CABLE BETWEEN THE C-ARM AND THE WORK STATION WOULD NOT WORK AND NEEDED TO BE REPLACED AS THE SYSTEM WOULD NOT START. NO PT INJURY WAS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | STENOSCOP | FLUOROSCOPIC X-RAY | JAA | GE MEDICAL SYSTEMS (INDIA) PRIVATE, LTD. (GE PRIVATE) | STENOSCOP |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |