COMPAX 40E
Received Mar 10, 2009 · Event occurred Feb 9, 2009
Report 2126677-2009-00016 · MDR key 1441636
Device
Manufacturer
Ge Medical Systems, LlcModel number
XRA505Product problems
- Device Inoperable
Patient
Not reported
- No Known Impact Or Consequence To Patient
Narrative
Description of Event or Problem
IT WAS REPORTED AT THE SITE THE TABLE DID NOT LOCK. 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
DURING INSPECTION OF THE SYSTEM, THE GE FIELD ENGINEER (FE) COULD NOT REPRODUCE THE ALLEGED MALFUNCTION. THE FE FOUND NO EVIDENCE INDICATIVE OF A DEVICE MALFUNCTION. THE REPORT INDICATED THAT THE TABLE DID NOT LOCK. ADDITIONAL INFORMATION WAS NOT OBTAINED FROM THE SITE DESPITE MULTIPLE ATTEMPTS MADE BY THE FE. THE INFORMATION CURRENTLY AVAILABLE THUS FAR REASONABLY SUGGESTED MOVEMENT OF THE TABLETOP WITHOUT RESISTANCE IN BOTH LATERAL AND LONGITUDINAL DIRECTIONS (FREE FLOAT).