inforMED
MalfunctionIZZ

COMPAX 40E

Received Feb 6, 2009 · Event occurred Jan 7, 2009

Report 2126677-2009-00006 · MDR key 1371204

Device

Model number

2225864

Catalog number

NA

Lot number

NA

Product problems

  • Unintended System Motion
  • Loss of Power

Patient

NA

  • No Consequences Or Impact To Patient

Narrative

Description of Event or Problem

IT WAS REPORTED THAT THE TABLE LOCKS WAS NOT ACTUATING DUE TO A POWER LOSS, CAUSING TO THE TABLETOP TO MOVE IN BOTH LONGITUDINAL AND LATERAL DIRECTIONS WITHOUT RESISTANCE (FREE FLOAT). 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

GE FIELD ENGINEER (FE) EVALUATED THE SYSTEM AND FOUND THAT THE POWER LOSS WAS CAUSED BY A MALFUNCTION ON THE POWER SUPPLY AND LOGIC BOARDS IN THE BASE OF THE TABLE. THE FE REPLACED THE PARTS AND VERIFIED THAT THE TABLE LOCKS WERE PERFORMING AS EXPECTED.