FDA Adverse Event
Other
Summary report: N
INNOVA 4100 OMEGA V
MDR report key: 838421
·
Received February 20, 2007
Report
- Report Number
- 9611343-2007-00008
- Event Type
- Other
- Date Received
- February 20, 2007
- Date of Event
- January 25, 2007
- Report Date
- February 20, 2007
- Manufacturer
- GE MEDICAL SYSTEMS SCS
- Product Code
- IZI
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE INVESTIGATION INTO ROOT CAUSE IS ONGOING.
Description of Event or Problem · 1
IT WAS REPORTED THAT A PATIENT NEARLY FELL WHILE BEING TRANSFERRED FROM A GURNEY TO THE TABLE. THE PATIENT LANDED FEEL FIRST, CATCHING HIMSELF AND PREVENTING THE FALL. AN INJURY WAS NOT REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | INNOVA 4100 OMEGA V | VASCULAR | IZI | GE MEDICAL SYSTEMS SCS | 2320045-2 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 78 YR |