FDA Adverse Event
Malfunction
Summary report: N
STENOSCOP
MDR report key: 3093433
·
Received April 26, 2013
Report
- Report Number
- 1720753-2013-05371
- Event Type
- Malfunction
- Date Received
- April 26, 2013
- Date of Event
- April 17, 2013
- Report Date
- April 26, 2013
- Manufacturer
- GE OEC MEDICAL SYSTEMS (SLC)
- Product Code
- JAA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FR
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
A GE SVC REP PERFORMED AN ON SITE INVESTIGATION. NO CONCLUSION CAN BE DRAWN AS FURTHER REPAIR INFO IS UNAVAILABLE AT THIS TIME.
Description of Event or Problem · 1
THE CUSTOMER REPORTED THAT THERE WAS A PROBLEM WITH THE ON/OFF BUTTON AND THEY WERE UNABLE TO TURN THE SYS ON. THERE IS NO REPORT OF PT INJURY ASSOCIATED WITH THE EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 181559 | STENOSCOP | FLUOROSCOPIC X-RAY | JAA | GE OEC MEDICAL SYSTEMS (SLC) | STENOSCOP |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |