COMPAX 40E
Received Feb 29, 2008 · Event occurred Jan 31, 2008
Report 2126677-2008-00011 · MDR key 1004847
Device
Product problems
- Locking mechanism failure
Patient
NA
- No Patient Involvement
Narrative
Description of Event or Problem
IT WAS REPORTED THAT THE COMPAX 40E TABLE LOCKS DID NOT FUNCTION. THERE WAS NEITHER INJURY REPORTED NOR PATIENT INVOLVEMENT. THE CONCERN FOR A SERIOUS INJURY A PATIENT WERE TO BECOME UNSTEADY AND FALL AS RESULT OF THE TABLE LOCKS FAILURE.
Additional Manufacturer Narrative
A GE FIELD ENGINEER (FE) EVALUATED THE SYSTEM AND FOUND THAT THE RIGHT PEDAL TRANSVERSE LOCK WAS NOT FUNCTIONING PROPERLY. THE FE REPLACED THE PEDAL LOCK HARDWARE. VERIFIED TABLE LOCK FUNCTIONALITY, AND RETURNED THE PRODUCT TO SERVICE. PROCEDURES ARE CURRENTLY IN PLACE PER THE PREVENTATIVE MAINTENANCE MANUAL TO CHECK THE FUNCTIONALITY OF THE TABLE LOCKS.