FDA Adverse Event
Malfunction
Summary report: N
STENSOCOP
MDR report key: 3231047
·
Received July 12, 2013
Report
- Report Number
- 1720753-2013-08060
- Event Type
- Malfunction
- Date Received
- July 12, 2013
- Date of Event
- May 24, 2013
- Report Date
- July 12, 2013
- Manufacturer
- GE OEC MEDICAL SYSTEMS (SLC)
- Product Code
- JAA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- EZ
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
NO CONCLUSION CAN BE DRAWN AS REPAIR INFORMATION IS UNAVAILABLE AT THIS TIME.
Description of Event or Problem · 1
THE MAIN FUSE INTERMITTENTLY WOULD FAIL AND THE SYSTEM WOULD NOT WORK. THIS SITUATION RENDERED THE SYSTEM UNUSABLE. THERE IS NO REPORT OF PT INJURY ASSOCIATED WITH THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 323239 | STENSOCOP | FLUOROSCOPIC X-RAY | JAA | GE OEC MEDICAL SYSTEMS (SLC) | STENSOCOP |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |