COMPAX 40E
Received Apr 7, 2008 · Event occurred Jan 2, 2008
Report 2126677-2008-00028 · MDR key 1026158
Device
Product problems
- Locking mechanism failure
Patient
NA
- No Consequences Or Impact To Patient
Narrative
Additional Manufacturer Narrative
A GE FIELD ENGINEER (FE) EVALUATED THE SYSTEM AND FOUND THAT A MALFUNCTION OF THE MICROSWITCH IN THE FOOT CONTROL ASSEMBLY PREVENTED THE TABLE LOCKS FROM ENGAGING. THE FE REPLACED THE SWITCHES AND VERIFIED TABLE LOCK FUNCTIONALITY. PROCEDURES ARE CURRENTLY IN PLACE PER THE PREVENTATIVE MAINTENANCE MANUAL TO INSPECT THE CONDITION AND FUNCTIONALITY OF CONTROL PEDALS AND MOVEMENT INHIBIT BUTTONS.
Description of Event or Problem
IT WAS REPORTED THAT THE COMPAX 40E TABLE LOCKS DID NOT ENGAGE, CAUSING THE TABLE TO MOVE FREELY. THERE WAS NEITHER INJURY REPORTED NOR PATIENT INVOLVEMENT. THE CONCERN IS FOR A SERIOUS INJURY IF A PATIENT WERE TO BECOME UNSTEADY AND FALL AS RESULT OF FREE TABLE MOVEMENT.