inforMED
MalfunctionIZZ

COMPAX 40E

Received Nov 12, 2008 · Event occurred Sep 26, 2008

Report 2126677-2008-00093 · MDR key 1235627

Device

Model number

45435245

Catalog number

NA

Lot number

NA

Product problems

  • Unintended System Motion
  • Device Inoperable

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 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) FOUND A BLOWN FUSE, CAUSING POWER LOSS TO THE TABLE LOCKS. AS A RESULT, THE LOCKS DID NOT ENGAGE. THE FE REPLACED THE FUSE AND VERIFIED THAT THE TABLE LOCKS ARE PERFORMING ACCORDING TO SPECIFICATIONS.