FDA Adverse Event
Malfunction
Summary report: N
STENOSCOP
MDR report key: 2982128
·
Received February 8, 2013
Report
- Report Number
- 1720753-2013-01570
- Event Type
- Malfunction
- Date Received
- February 8, 2013
- Date of Event
- January 25, 2013
- Report Date
- February 8, 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 SERVICE REPRESENTATIVE PERFORMED AN ONSITE INVESTIGATION. A CONNECTOR WAS RESEALED. THE SYSTEM WAS THEN FOUND TO BE OPERATING AS INTENDED.
Description of Event or Problem · 1
THE CUSTOMER REPORTED THAT THE SYSTEM'S LIVE IMAGE SCREEN WENT BLANK AND THEY WERE UNABLE TO PERFORM FLUOROSCOPY DUE TO A COMMUNICATION ERROR MESSAGE. THERE IS NO REPORT OF PT INJURY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 53732 | STENOSCOP | FLUOROSCOPIC X-RAY | JAA | GE OEC MEDICAL SYSTEMS (SLC) | STENOSCOP |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |