FDA Adverse Event
Malfunction
Summary report: N
INNOVA 3100
MDR report key: 1080275
·
Received July 22, 2008
Report
- Report Number
- 9611343-2008-00038
- Event Type
- Malfunction
- Date Received
- July 22, 2008
- Date of Event
- June 25, 2008
- Manufacturer
- GE MEDICAL SYSTEMS SCS
- Product Code
- IZI
- PMA / PMN Number
- K052412
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MA, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
IT WAS REPORTED THAT WHEN THE PT WAS BEING TRANSFERRED FROM THE TABLE TO THE GURNEY, THE OMEGA 5 TABLE TOP ROTATION LOCKS ALLEGEDLY DID NOT HOLD AND THE TABLE TOP ROTATED. THE PT THEN FELL TO THE FLOOR. PT INJURY IS UNK AT THS TIME. GE HEALTHCARE'S INVESTIGATION INTO THE REPORTED OCCURENCE IS STILL ONGOING. A FOLLOW-UP REPORT WILL BE ISSUED WHEN THE INVESTIGATION HAS BEEN COMPLETED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | INNOVA 3100 | VASCULAR X-RAY SYSTEM | IZI | GE MEDICAL SYSTEMS SCS |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |