MalfunctionIZZ
COMPAX 40E
Received Oct 16, 2008 · Event occurred Sep 17, 2008
Report 2126677-2008-00084 · MDR key 1203586
Device
Product problems
- Unstable
- Device Operates Differently Than Expected
- Unintended Movement
Patient
NA
- No Known Impact Or Consequence To Patient
Narrative
Description of Event or Problem
IT WAS REPORTED THAT THE TABLE LOCKS DID NOT ACTUATE, THAT CAUSED THE TABLETOP TO UNEXPECTEDLY MOVE IN BOTH LONGITUDINAL AND LATERAL DIRECTIONS WITHOUT RESISTANCE (FREE FLOAT). THERE WAS 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
THE GE FIELD ENGINEER (FE) FOUND A MALFUNCTION IN THE MAIN POWER SUPPLY BOARD. THE FE REPLACED THE BOARD AND TESTED THE SYSTEM. THE TABLELOCKS WERE VERIFIED TO BE PERFORMING WITHIN SPECIFICATIONS.