MalfunctionIZZ
COMPAX 40E
Received Feb 22, 2008 · Event occurred Jan 25, 2008
Report 2126677-2008-00014 · MDR key 1001219
Device
Product problems
- Unintended System Motion
Patient
NA
- No Patient Involvement
Narrative
Description of Event or Problem
IT WAS REPORTED THAT THE COMPAX 40E TABLE WAS MOVING FREELY. THERE WAS NEITHER INJURY REPORTED NOR PT INVOLVEMENT. THE CONCERN IS FOR A SERIOUS INJURY IF A PT WERE TO BECOME UNSTEADY AND FALL AS RESULT OF A MOVING TABLE.
Additional Manufacturer Narrative
THE GE FIELD ENGINEER (FE) EVALUATED THE SYSTEM AND FOUND THAT THE TABLE FOOTSWITCH WAS DEFECTIVE. THE FE REPLACED THE FOOTSWITCH AND RETURNED THE PRODUCT BACK TO SERVICE. PREVENTIVE MAINTENANCE PROCEDURES ARE CURRENTLY IN PLACE PER THE SYSTEM'S PERIODIC MAINTENANCE MANUAL THAT INCLUDES INSTRUCTIONS TO INSPECT THE CONDITION AND FUNCTIONALITY OF TABLE CONTROL PEDALS.