DEFINIUM 8000
Received Apr 22, 2009 · Event occurred Mar 20, 2009
Report 2126677-2009-00029 · MDR key 1424813
Device
Generic name
Kpr/izf/mqb
Manufacturer
Ge Medical Systems, LlcModel number
5131070Catalog number
NA
Lot number
NA
Product problems
- Unintended System Motion
Patient
NA
- No Patient Involvement
Narrative
Description of Event or Problem
IT WAS REPORTED THAT THE TABLE LOCKS DISENGAGED WITHOUT FOOT PEDAL ACTIVATION, CAUSING AN UNEXPECTED FREE FLOAT MOTION OF THE TABLETOP IN THE LONGITUDINAL AND LATERAL DIRECTIONS. THE SITE INDICATED THAT THE FLOAT OCCURRED AS THE TABLE WAS LOWERED TO ITS LOWEST SETTING. THERE WAS NO PT INVOLVEMENT AND NO INJURY REPORTED. THIS SITUATION COULD CONTRIBUTE TO AN INJURY IF A PT OR OPERATOR WERE UNAWARE OF THIS CONDITION WHILE LOADING OR UNLOADING A PT. THE ENSUING INSTABILITY COULD LEAD TO A FALL.
Additional Manufacturer Narrative
GE FIELD ENGINEER (FE) FOUND THAT THE FOOT PEDAL MECHANISM WAS NOT ALIGNED PROPERLY. THE FE READJUSTED THE PEDAL AND VERIFIED THE TABLE LOCKS WERE PERFORMING AS EXPECTED.