FDA Adverse Event
Death
Summary report: N
INNOVA 4100
MDR report key: 1209163
·
Received October 8, 2008
Report
- Report Number
- 9611343-2008-00044
- Event Type
- Death
- Date Received
- October 8, 2008
- Date of Event
- July 15, 2008
- Report Date
- August 1, 2008
- Manufacturer
- GE MEDICAL SYSTEMS SCS
- Product Code
- IZI
- PMA / PMN Number
- K052412
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
IT WAS REPORTED THAT THE ROOM WAS WARM WHEN THEY ATTEMPTED TO USE THE SYSTEM. THE PT WAS TRANSFERRED TO ANOTHER LOCATION AND LATER DIED. SERVICE ENGINEER CHECKED THE SYSTEM, AND FOUND THE OVERTEMP BREAKER TRIPPED. THE SYSTEM WAS RESET AND CHECKED. GE HEALTHCARE'S INVESTIGATION INTO THE REPORTED OCCURRENCE 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 4100 | VASCULAR X-RAY SYSTEM | IZI | GE MEDICAL SYSTEMS SCS | 2228054-3 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Death |