FDA Adverse Event
Malfunction
Summary report: N
STENOSCOP
MDR report key: 3162211
·
Received June 3, 2013
Report
- Report Number
- 1720753-2013-06652
- Event Type
- Malfunction
- Date Received
- June 3, 2013
- Date of Event
- May 21, 2013
- Report Date
- June 3, 2013
- Manufacturer
- GE OEC MEDICAL SYSTEMS (SLC)
- Product Code
- JAA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SP
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
A GE SERVICE REP PERFORMED AN ONSITE INVESTIGATION. THE LEFT MONITOR BNC CABLE WAS REPLACED. THE SYSTEM WAS THEN FOUND TO BE OPERATING AS INTENDED.
Description of Event or Problem · 1
THE CUSTOMER REPORTED THAT THE IMAGE WAS LOST WHEN THE LEFT MONITOR WAS MOVED. THIS RESULTED IN A LOSS OF LIVE IMAGE. THERE IS NO REPORT OF PT INJURY ASSOCIATED WITH THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 242495 | STENOSCOP | FLUOROSCOPIC X-RAY | JAA | GE OEC MEDICAL SYSTEMS (SLC) | STENOSCOP |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |