FDA Adverse Event
Malfunction
Summary report: N
GOLDSEAL LS QXI
MDR report key: 1011722
·
Received March 12, 2008
Report
- Report Number
- 2126677-2008-00021
- Event Type
- Malfunction
- Date Received
- March 12, 2008
- Date of Event
- October 10, 2007
- Report Date
- October 10, 2007
- Manufacturer
- GE MEDICAL SYSTEMS, LLC
- Product Code
- JAK
- PMA / PMN Number
- K000300
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MO, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE GE FIELD ENGINEER (FE) FOUND THAT THE SIX BOLTS HOLDING THE CRADLE TO THE TABLE WERE NOT PROPERLY SECURED, CAUSING THE TABLE TO TEETER. THE FE SECURED ALL THE BOLTS AND VERIFIED SYSTEM FUNCTIONALITY.
Description of Event or Problem · 1
THE TECHNOLOGIST REPORTED UNSTEADY CRADLE MOVEMENT AS THE PT WAS BEING PLACED INTO THE BORE. DURING THIS UNSTEADY MOVEMENT, THE PT GOT OFF THE TABLE, CAUSING THE CRADLE TO FALL OFF THE TABLE AND HIT THE GANTRY. THERE WAS NO INJURY SUSTAINED BY EITHER THE PT OR THE TECHNOLOGIST. THE CONCERN IS THAT A SERIOUS INJURY COULD RESULT IF THE CRADLE WERE TO FLIP OR TILT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | GOLDSEAL LS QXI | JAK | GE MEDICAL SYSTEMS, LLC | 2269165 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 63 YR |