inforMED
MalfunctionIZZ

COMPAX 40E

Received Sep 16, 2008 · Event occurred Mar 10, 2008

Report 2126677-2008-00069 · MDR key 1162224

Device

Model number

2142182

Catalog number

NA

Lot number

NA

Product problems

  • Unstable
  • Device Operates Differently Than Expected
  • Unintended Movement

Patient

NA

  • No Known Impact Or Consequence To Patient

Narrative

Description of Event or Problem

IT WAS REPORTED THAT THE TABLE LOCKS DID NOT ACTIVATE CAUSING FREE TABLETOP MOTION IN THE LATERAL DIRECTION WITH NO RESISTANCE. THERE WAS NO 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) FOUND A BROKEN WIRE THAT PREVENTED THE LATERAL LOCKS FROM ENGAGING. THE FE REPLACED THE CABLE ASSEMBLIES AND VERIFIED THAT THE TABLE LOCKS WERE PERFORMING ACCORDING TO SPECIFICATIONS.