inforMED
MalfunctionIZZ

COMPAX 40E

Received Sep 19, 2008 · Event occurred Jul 21, 2008

Report 2126677-2008-00070 · MDR key 1172855

Device

Model number

2134420

Catalog number

NA

Lot number

NA

Product problems

  • Resistance, loss of
  • Locking mechanism failure

Patient

NA

  • No Consequences Or Impact To Patient

Narrative

Description of Event or Problem

IT WAS REPORTED THAT THE TABLE LOCKS DID NOT ACTUATE, CAUSING THE TABLETOP TO MOVE IN TWO DIRECTIONS WITHOUT RESISTANCE. THERE WAS NO INJURY REPORTED. THE ISSUE WAS DISCOVERED AS THE OPERATOR WAS POSITIONING THE PATIENT. THIS SITUATION COULD CONTRIBUTE TO AN INJURY IF A PATIENT OR OPERATOR WERE UNAWARE OF THIS CONDITION WHILE LOADING A PATIENT. THE ENSURING INSTABILITY COULD LEAD TO A FALL.

Additional Manufacturer Narrative

THE GE FIELD ENGINEER (FE) EVALUATED THE SYSTEM AND FOUND THAT THE FUSE HAD BLOWN, RESULTING IN THE RELEASE OF THE TABLE LOCKS. THE FE REPLACED THE FUSE AND VERIFIED THAT THE TABLE LOCKS WERE PERFORMING ACCORDING TO SPECIFICATIONS.