FDA Adverse Event
Malfunction
Summary report: N
STENOSCOP
MDR report key: 2934233
·
Received January 7, 2013
Report
- Report Number
- 1720753-2013-00220
- Event Type
- Malfunction
- Date Received
- January 7, 2013
- Date of Event
- December 18, 2012
- Report Date
- January 7, 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 REP PERFORMED AN ONSITE INVESTIGATION AND THE MEMORY WAS DETERMINED TO BE DEFECTIVE AND THE CUSTOMER WAS ISSUED A QUOTE FOR THE PART REPLACEMENT. NO FURTHER REPAIR INFO IS AVAILABLE AT THIS TIME.
Description of Event or Problem · 1
THE CUSTOMER REPORTED THAT THE SCREEN WAS FREEZING AND THEN TURNING BLACK. THIS RESULTED IN A LOSS OF THE LIVE IMAGE. THERE IS NO REPORT OF PT INJURY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 8392 | STENOSCOP | FLUOROSCOPIC X-RAY | JAA | GE OEC MEDICAL SYSTEMS (SLC) | STENOSCOP |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |