MalfunctionIZZ
COMPAX40E
Received Aug 4, 2008 · Event occurred Jul 5, 2008
Report 2126677-2008-00055 · MDR key 1096911
Device
Product problems
- Locking mechanism failure
Patient
NA
- No Patient Involvement
Narrative
Description of Event or Problem
IT WAS REPORTED THE TABLE LOCKS DID NOT ACTUATE, CAUSING THE TABLETOP TO MOVE IN TWO AXES WITHOUT RESISTANCE. THERE WAS NEITHER PATIENT INVOLVEMENT NOR INJURY REPORTED. THIS SITUATION COULD CONTRIBUTE TO AN INJURY IF A PATIENT OR OPERATOR WERE UNAWARE OF THIS CONDITION WHILE LOADING A PATIENT. THE ENSUING INSTABILITY COULD LEAD TO A FALL.
Additional Manufacturer Narrative
THE GE FIELD ENGINEER (FE) EVALUATED THE SYSTEM AND FOUND A BLOWN FUSE IN THE TABLE LOCK CIRCUIT. THE FE REPLACED THE FUSED, ADJUSTED THE FOOTSWITCH ASSEMBLY, AND VERIFIED THAT THE TABLE LOCKS WERE PERFORMING ACCORDING TO SPECIFICATIONS.