FDA Adverse Event
Injury
Summary report: N
ADVANTX LCA
MDR report key: 2589914
·
Received May 23, 2012
Report
- Report Number
- 9611343-2012-00019
- Event Type
- Injury
- Date Received
- May 23, 2012
- Report Date
- May 9, 2012
- Manufacturer
- GE MEDICAL SYSTEMS SCS
- Product Code
- IZI
- PMA / PMN Number
- K945375
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TN, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
PT DATA AND INCIDENT DATE REQUESTED BUT THE HOSPITAL HAS NOT PROVIDED THEM.
Description of Event or Problem · 1
IT WAS REPORTED THAT A TECHNOLOGIST TRIPPED AND FELL AS A RESULT OF GETTING HIS/HER FOOT TANGLED IN CABLES BUNDLED UNDER THE TABLE OF THE SYSTEM. THE FALL RESULTED IN A BROKEN RIB AND PATELLA. GE HEALTHCARE'S INVESTIGATION IS ONGOING. A FOLLOW UP REPORT WILL BE SUBMITTED ONCE THE INVESTIGATION HAS BEEN COMPLETED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ADVANTX LCA | ANGIOGRAPHIC X-RAY SYSTEM | IZI | GE MEDICAL SYSTEMS SCS |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |