inforMED
MalfunctionIZZ

COMPAX 40E

Received Feb 26, 2009 · Event occurred Feb 1, 2009

Report 2126677-2009-00011 · MDR key 1334720

Device

Model number

2225864

Catalog number

NA

Lot number

NA

Product problems

  • Device Slipped
  • Unintended Movement

Patient

NA

  • No Known Impact Or Consequence To Patient

Narrative

Description of Event or Problem

IT WAS REPORTED THE TABLE LOCKS DID NOT ACTUATE, CAUSING THE TABLETOP TO UNEXPECTEDLY 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

PRELIMINARY INSPECTION PERFORMED BY THE GE FIELD ENGINEER (FE) REVEALED THAT THE ALLEGED FLOAT WAS CAUSED BY POWER LOSS TO THE TABLE LOCKS DUE TO A BLOWN FUSE. THE FE REPLACED THE FUSE, BUT IT WAS REPORTED THAT THE POWER LOSS REOCCURRED THE NEXT DAY. FURTHER INVESTIGATION SHOWED THAT THE LEFT TABLE HORIZONTAL LOCK WAS LOOSE. HARDWARE HAD FALLEN OUT AND THE LOCK WAS MOVING AROUND AND WAS INTERMITTENTLY SHORTING OUT AGAINST TERMINAL STRIP, HENCE BLOWING THE FUSE. THE FE FASTENED THE LOCK BACK INTO PLACE AND VERIFIED THAT THE REPORTED ISSUE DID NOT RECUR.