COMPAX 40E
Received Dec 8, 2008 · Event occurred Oct 9, 2008
Report 2126677-2008-00102 · MDR key 1296298
Device
Product problems
- Detachment Of Device Component
- Component Falling
Patient
NA
- No Consequences Or Impact To Patient
Narrative
Description of Event or Problem
IT WAS REPORTED THAT THE COLLIMATOR WEIGHING APPROXIMATELY 40LBS DETACHED AND FELL FROM THE X-RAY TUBE ASSEMBLY, WHILE THE TECHNOLOGIST WAS POSITIONING THE TUBE FROM A HORIZONTAL TO AN ANGLED POSITION. THE TECHNOLOGIST WAS ABLE TO CATCH THE COLLIMATOR BEFORE IT FELL TO THE TABLE. NO INJURY WAS REPORTED. THE CONCERN IS FOR A SERIOUS INJURY, IF THE COLLIMATOR WERE TO FALL AND CONTACT A PATIENT OR OPERATOR DUE TO ITS WEIGHT.
Additional Manufacturer Narrative
GE FIELD ENGINEER FOUND THAT THE BOLTS THAT HOLD THE COLLIMATOR PLATE TO THE TUBE BECAME LOOSE, ALLOWING THE COLLIMATOR TO DETACH AND FALL FROM THE X-RAY TUBE ASSEMBLY. VISUAL INSPECTION OF THE COLLIMATOR REVEALED NO DAMAGE OBTAINED DURING THE DROP. THE FE RE-INSTALLED THE COLLIMATOR IN ACCORDANCE TO THE SERVICE MANUAL.