inforMED
MalfunctionIZZ

COMPAX 40E

Received Sep 24, 2008 · Event occurred Feb 28, 2008

Report 2126677-2008-00072 · MDR key 1190767

Device

Product problems

  • Unstable
  • Unintended Movement

Patient

Not reported

  • No Patient Involvement

Narrative

Description of Event or Problem

IT WAS REPORTED THAT THE TABLETOP WAS UNEXPECTEDLY MOVING IN BOTH LATERAL AND LONGITUDINAL DIRECTIONS WITHOUT RESISTANCE, AS THE TABLE WAS BEING SETUP FOR USE. THERE WAS NO INJURY REPORTED. THIS SITUATION COULD CONTRIBUTE TO AN INJURY IF A PT OR OPERATOR WERE UNAWARE OF THIS CONDITION WHILE LOADING A PT. THE ENSUING INSTABILITY COULD LEAD TO A FALL.

Additional Manufacturer Narrative

THE GE FIELD ENGINEER (FE) EVALUATED THE SYSTEM AND FOUND THAT THE HANDSET'S MICROSWITCH ACTIVATING LEVER WAS WORN, CAUSING A MICROSWITCH MALFUNCTION. THIS MALFUNCTION PREVENTED THE LOCKS FROM ENGAGING. THE FE MADE ADJUSTMENTS TO THE HANDSET'S MICROSWITCH AND VERIFIED THAT IT WAS WORKING PROPERLY.