FDA Adverse Event
Malfunction
Summary report: N
STENOSCOP
MDR report key: 2850326
·
Received November 26, 2012
Report
- Report Number
- 1720753-2012-09605
- Event Type
- Malfunction
- Date Received
- November 26, 2012
- Date of Event
- November 9, 2012
- Report Date
- November 26, 2012
- Manufacturer
- GE OEC MEDICAL SYSTEMS (SLC)
- Product Code
- JAA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IN
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
A GE SERVICE REPRESENTATIVE PERFORMED AN ONSITE INVESTIGATION. THE GRID FROM THE IMAGE INTENSIFIER WAS REMOVED. THE SYSTEM WAS THEN FOUND TO BE OPERATING AS INTENDED.
Description of Event or Problem · 1
THE CUSTOMER REPORTED THAT THERE WAS A SHADOW IN THE IMAGE. CONSEQUENTLY, THE IMAGE QUALITY WAS DEGRADED TO THE POINT WHERE THE SYSTEM WAS RENDERED UNUSABLE. THERE IS NO REPORT OF PT INJURY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | STENOSCOP | FLUOROSCOPIC X-RAY | JAA | GE OEC MEDICAL SYSTEMS (SLC) | STENOSCOP |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |