inforMED
MalfunctionIZZ

COMPAX 40E

Received Nov 12, 2008 · Event occurred Oct 24, 2008

Report 2126677-2008-00092 · MDR key 1235628

Device

Product problems

  • Unintended System Motion

Patient

Not reported

  • 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 THE 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

THE GE FIELD ENGINEER (FE) REPORTED THAT THE TABLE LOCKS DID NOT ACTUATE DUE TO LOSS OF POWER. THE FE REPLACED THE TABLE FUSE, AND THE FLOAT COULD NOT BE DUPLICATED. THE FE VERIFIED THAT THE TABLE LOCKS ARE PERFORMING ACCORDING TO SPECIFICATIONS.