FDA Adverse Event
Injury
Summary report: N
INFINIA-II 3/8
MDR report key: 1990638
·
Received February 8, 2011
Report
- Report Number
- 9613299-2011-00002
- Event Type
- Injury
- Date Received
- February 8, 2011
- Date of Event
- January 14, 2011
- Report Date
- February 8, 2011
- Manufacturer
- GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING
- Product Code
- KPS
- PMA / PMN Number
- K022960
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MT, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
IT WAS REPORTED THAT A GE HEALTHCARE FIELD SVC ENGINEER WAS INJURED WHILE PERFORMING A COLLIMATOR EXCHANGE ON AN INFINIA-II 3/8 SYS. THE FIELD ENGINEER'S MIDDLE FINGER ON THE LEFT HAND WAS CAUGHT BETWEEN THE COLLIMATOR AND DETECTOR HEAD RESULTING IN BROKEN BONES. THE FIELD ENGINEER WAS SEEN IN THE EMERGENCY ROOM AND SURGERY ON HER FINGER WAS PERFORMED THE SAME DAY. GE HEALTHCARE'S INVESTIGATION INTO THE REPORTED OCCURRENCE IS ONGOING. A F/U REPORT WILL BE SUBMITTED ONCE THE INVESTIGATION IS COMPLETED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | INFINIA-II 3/8 | EMISSION COMPUTED TOMOGRAPHY SYSTEM | KPS | GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 51 YR | Required Intervention |