inforMED
MalfunctionIZZ

COMPAX 40E

Received Oct 20, 2008 · Event occurred Aug 16, 2008

Report 2126677-2008-00085 · MDR key 1204588

Device

Product problems

  • Unstable
  • Device Operates Differently Than Expected
  • Unintended Movement

Patient

Not reported

  • No Known Impact Or Consequence To Patient

Narrative

Additional Manufacturer Narrative

THE GE FIELD ENGINEER (FE) FOUND A BLOWN 2-AMP FUSE. WHEN THE FE REPLACED THE FUSE, IT WAS VERIFIED THAT THE LOCKS WERE PERFORMING ACCORDING TO SPECS.

Description of Event or Problem

IT WAS REPORTED THAT THE TABLE LOCKS DID NOT ACTUATE, CAUSING THE TABLETOP TO UNEXPECTEDLY MOVE IN BOTH THE LONGITUDINAL AND LATERAL DIRECTIONS WITHOUT RESISTANCE (FREE FLOAT). THE PROBLEM WAS DISCOVERED AS THE OPERATOR WAS POSITIONING THE PT. THERE WAS NO REPORT OF A FALL OR INJURY. THIS SITUATION COULD CONTRIBUTE TO AN INJURY IF A PT OR OPERATOR WERE UNAWARE OF THIS CONDITION WHILE LOADING OR UNLOADING A PT. THE ENSUING INSTABILITY COULD LEAD TO A FALL.