inforMED
MalfunctionIZZ

COMPAX 40E

Received May 6, 2009 · Event occurred Jan 15, 2009

Report 2126677-2009-00033 · MDR key 1427944

Device

Model number

XRA505

Product problems

  • Unstable
  • Device Operates Differently Than Expected
  • Unintended Movement

Patient

Not reported

  • No Known Impact Or Consequence To Patient

Narrative

Description of Event or Problem

IT WAS REPORTED THAT THE TABLE LOCKS DID NOT ACTUATE WHEN THE FOOT PEDAL WAS RELEASED, CAUSING THE TABLETOP TO UNEXPECTEDLY FREE FLOAT IN THE LONGITUDINAL AND LATERAL DIRECTIONS. THERE WAS NO INJURY REPORTED. THIS SITUATION COULD CONTRIBUTE TO AN INJURY IF A PATIENT OR OPERATOR WERE UNAWARE OF THIS CONDITION WHILE LOADING OR UNLOADING A PATIENT. THE ENSUING INSTABILITY COULD LEAD TO A FALL.

Additional Manufacturer Narrative

THE GE FIELD ENGINEER (FE) FOUND THAT THE UNEXPECTED FLOAT WAS CAUSED BY A LOOSE PLASTIC COVER THAT PREVENTED THE FOOT PEDAL FROM REACHING ITS RESTING POSITION. THIS SIMULATED A PEDAL ACTIVATION WHICH CAUSED THE LOCKS TO DISENGAGE AND ALLOW THE TABLETOP TO FLOAT. THE FE REATTACHED THE COVER AND ENSURED THAT THE PEDAL AND TABLE LOCKS WERE FUNCTIONING NOMINALLY.