COMPAX 40E
Received Mar 28, 2008 · Event occurred Jan 3, 2008
Report 2126677-2008-00026 · MDR key 1023534
Device
Product problems
- Locking mechanism failure
Patient
NA
- No Consequences Or Impact To Patient
Narrative
Description of Event or Problem
IT WAS REPORTED THAT THE COMPAX 40E TABLE LOCKS DID NOT ENGAGE, CAUSING THE TABLE TO MOVE FREELY IN BOTH LONGITUDINAL AND LATERAL DIRECTIONS. THERE WAS NEITHER INJURY REPORTED NOR PT INVOLVEMENT. THE CONCERN IS FOR A SERIOUS INJURY IF A PT WAS TO BECOME UNSTEADY AND FALL AS A RESULT OF FREE MOVEMENT OF THE TABLE.
Additional Manufacturer Narrative
A GE FIELD ENGINEER (FE) EVALUATED THE SYSTEM AND FOUND THAT THE PAD OF THE LEFT 4-WAY TABLE LOCK RELEASE PEDAL WAS DELAMINATED AND WAS JAMMED IN THE PEDAL MECHANISM. THIS DID NOT ALLOW THE RELEASE OF THE PEDAL, PREVENTING THE TABLE LOCKS FROM ENGAGING. THE FE REPLACED THE FOUR PEDALS AND VERIFIED TABLE LOCK FUNCTIONALITY. PROCEDURES ARE CURRENTLY IN PLACE PER THE PREVENTATIVE MAINTENANCE MANUAL TO INSPECT THE CONDITION AND FUNCTIONALITY OF CONTROL PEDALS.