FDA Adverse Event
Malfunction
Summary report: N
STENOSCOP
MDR report key: 2934122
·
Received January 3, 2013
Report
- Report Number
- 1720753-2013-00072
- Event Type
- Malfunction
- Date Received
- January 3, 2013
- Date of Event
- June 6, 2011
- Report Date
- January 3, 2013
- Manufacturer
- GE OEC MEDICAL SYSTEMS (SLC)
- Product Code
- JAA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
A GE REP EVALUATED THE SYSTEM AND REPLACED THE KEYBOARD. THE SYSTEM OPERATES AS INTENDED.
Description of Event or Problem · 1
THE CUSTOMER REPORTED THAT 'X-RAY IS NOT EXPOSED'. THIS WOULD RESULT IN NO LIVE IMAGE BEING DISPLAYED. THERE IS NO REPORT OF INJURY OR DEATH ASSOCIATED WITH THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 3822 | STENOSCOP | FLUOROSCOPIC X-RAY | JAA | GE OEC MEDICAL SYSTEMS (SLC) | STENOSCOP |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |