COMPAX 40E
Received Dec 22, 2008 · Event occurred Oct 27, 2008
Report 2126677-2008-00105 · MDR key 1349145
Device
Manufacturer
Ge Medical Systems, LlcModel number
45434285Product problems
- Loss of Power
- Unstable
- Device Operates Differently Than Expected
- Unintended Movement
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 TECHNOLOGIST RELEASED THE FOOT PEDAL DUE TO POWER LOSS, CAUSING THE TABLETOP TO UNEXPECTEDLY MOVE IN BOTH LATERAL AND LONGTITUDINAL 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 THE SUPPLY FUSE TO THE MAIN INPUT POWER TRANSFORMER (F3) WAS OPEN, WHICH SHUT OFF THE TABLE CONTROL AND BRAKES. FOLLOWING THE FUSE F3 REPLACEMENT, ANOTHER FUSE FAILURE OCCURRED LATER IN THE DAY DURING PREVENTATIVE MAINTENANCE. THE FE'S INVESTIGATION REVEALED THAT THE TABLE POWER INPUT TOROID TRANSFORMER WAS THE LIKELY CAUSE OF THE SECOND FAILURE. THE FE REPLACED THE TOROID TRANSFORMER AND VERIFIED THAT THE REPLACEMENT FIXED THE TABLE FLOAT. THE SITE HAS EXPERIENCED NO SIMILAR PROBLEM SINCE THE INCIDENT.