inforMED
MalfunctionIZZ

COMPAX 40E

Received Dec 16, 2008 · Event occurred Oct 22, 2008

Report 2126677-2008-00104 · MDR key 1265724

Device

Product problems

  • Unintended System Motion
  • Device Inoperable

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 AS THE PT WAS BEING PREPARED FOR AN EXAM, CAUSING UNEXPECTED LATERAL MOTION OF THE TABLETOP WITHOUT RESISTANCE (LATERAL 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 A PT. THE ENSUING INSTABILITY COULD LEAD TO A FALL.

Additional Manufacturer Narrative

UPON DISCOVERY OF THE UNEXPECTED LATERAL FLOAT, THE SITE WAS STILL ABLE TO USE THE TABLE FOR THE EXAM WHEN THEY USED THE REDUNDANT MECHANICAL INTERLOCK TO INHIBIT LATERAL MOTION. THE GE FIELD ENGINEER (FE) EVALUATED THE SYSTEM AND FOUND A DAMAGED MICROSWITCH. THE FE REPLACED THE MICROSWITCH AND VERIFIED THAT THE TABLE LOCKS WERE PERFORMING ACCORDING TO SPECIFICATIONS.