FDA Adverse Event
Malfunction
Summary report: N
GE OEC STENOSCOP
MDR report key: 1182727
·
Received September 25, 2008
Report
- Report Number
- 9617766-2008-01312
- Event Type
- Malfunction
- Date Received
- September 25, 2008
- Date of Event
- August 26, 2008
- Report Date
- September 19, 2008
- Manufacturer
- GE OEC MEDICAL SYSTEMS INC.
- Product Code
- JAA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- BR
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
A GE REP EVALUATED THE SYSTEM BUT DID NOT REPORT ACTIONS TAKEN.
Description of Event or Problem · 1
CUSTOMER REPORTED THE CAMERA TURNS IN JUST ONE DIRECTION AND SYSTEM INTERMITTENTLY LOSES THE IMAGE. NO PATIENT INJURY WAS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | GE OEC STENOSCOP | FLUOROSCOPIC X-RAY | JAA | GE OEC MEDICAL SYSTEMS INC. | STENOSCOP | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |