FDA Adverse Event
Malfunction
Summary report: N
STENOSCOPE
MDR report key: 1220665
·
Received October 31, 2008
Report
- Report Number
- 9617766-2008-01413
- Event Type
- Malfunction
- Date Received
- October 31, 2008
- Date of Event
- October 20, 2008
- Report Date
- October 30, 2008
- Manufacturer
- GE OEC MEDICAL SYSTEMS, INC.
- Product Code
- JAA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
THE C-ARM VERTICAL LIFT WAS REPAIRED, AND IS NOW WORKING AS INTENDED.
Description of Event or Problem · 1
THE CUSTOMER REPORTED THE C-ARM VERTICAL LIFT WILL NOT LOWER.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | STENOSCOPE | FLUOROSCOPIC X-RAY | JAA | GE OEC MEDICAL SYSTEMS, INC. | NA | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |