COMPAX 40E
Received Apr 30, 2009 · Event occurred Mar 30, 2009
Report 2126677-2009-00031 · MDR key 1426096
Device
Product problems
- Component Falling
Patient
NA
- No Patient Involvement
Narrative
Description of Event or Problem
IT WAS REPORTED THAT THE WALL STAND BUCKY HOLDER ASSEMBLY FELL FROM APPROXIMATELY 2 FEET ABOVE THE GROUND AND CONTACTED THE FLOOR. PRIOR TO THE INCIDENT, NO PATIENT WAS IN THE ROOM AND THE TECHNOLOGIST NEAR THE WALL STAND WAS SETTING UP THE ASSEMBLY. WHEN THE TECHNOLOGIST TURNED AROUND, THE ASSEMBLY FELL. THERE WAS NO INJURY SUSTAINED AS THERE WAS NO CONTACT WITH THE TECHNOLOGIST. DUE TO THE WEIGHT OF THE ASSEMBLY, THE CONCERN IS FOR A SERIOUS INJURY IF THE ASSEMBLY WERE TO FALL AND CONTACT A PATIENT OR TECHNOLOGIST.
Additional Manufacturer Narrative
THE ASSEMBLY IS MOUNTED BY SMALL METRIC SCREWS ON THE TOP AND BOTTOM OF THE BUCKY TRAY ASSEMBLY. DURING INSPECTION, THE GE FIELD ENGINEER (FE) FOUND THAT THE MOUNTING SCREWS AT THE BOTTOM OF THE ASSEMBLY HAD COME LOOSE AND BROKE. THE FE ALSO INSPECTED THE ASSEMBLY AND FOUND THAT THE BOTTOM TRIM COVER WAS DAMAGED AS A RESULT OF THE FALL. THE FE REPLACED BOTH THE BOTTOM TRIM COVER AND THE MOUNTING SCREWS.