COMPAX 400
Received Jan 11, 2009 · Event occurred Nov 4, 2008
Report 9611343-2009-00007 · MDR key 1311013
Device
Product problems
- Unintended System Motion
Patient
NA
- No Known Impact Or Consequence To Patient
Narrative
Description of Event or Problem
IT WAS REPORTED THAT THE TABLE LOCKS WERE NOT ACTUATING WHEN THE FOOT PEDAL WAS RELEASED, CAUSING THE TABLETOP UNEXPECTEDLY MOVE IN BOTH LONGITUDINAL AND LATERAL DIRECTIONS WITHOUT RESISTANCE (FREE FLOAT). THE ISSUE WAS DISCOVERED DURING SET-UP. THERE WAS NO INJURY REPORTED. THIS SITUATION COULD CONTRIBUTED TO AN INJURY IF A PATIENT OR OPERATOR WERE UNAWARE OF THIS CONDITION WHILE LOADING OR UNLOADING A PATIENT. THE ENSURING INSTABILITY COULD LEAD TO A FALL.
Additional Manufacturer Narrative
GE FIELD ENGINEER (FE) FOUND THAT THE UNEXPECTED FLOAT WAS DUE TO LOSS OF POWER TO THE TABLE LOCKS. THE POWER LOSS WAS CAUSED BY A BROKEN CABLE. THE FE REPLACED THE CABLE AND VERIFIED THAT THE TABLE LOCKS WERE PERFORMING ACCORDING TO SPECIFICATIONS.