MalfunctionIZZ
MONITROL 15
Received Mar 21, 2008 · Event occurred Mar 5, 2008
Report 2126677-2008-00023 · MDR key 1019857
Device
Product problems
- Detachment Of Device Component
- Component Falling
Patient
NA
- No Consequences Or Impact To Patient
Narrative
Description of Event or Problem
AFTER COMPLETION OF AN EXAM, AND THE PT LEFT THE ROOM, THE OPERATOR ANGULATED THE TUBE FROM A HORIZONTAL TO A VERTICAL POSITION WHEN THE COLLIMATOR DETACHED AND FELL ONTO THE TABLE. THERE WAS NO INJURY REPORTED. THE CONCERN IS THAT A SERIOUS INJURY MAY RESULT IF THE FALLING COLLIMATOR WERE TO CONTACT THE PT OR OPERATOR.
Additional Manufacturer Narrative
A GE FIELD ENGINEER (FE) EVALUATED THE SYSTEM AND FOUND THAT ONE COLLIMATOR-TUBE INTERFACE SCREW WAS MISSING, ONE WAS LOOSE, AND ONE WAS SECURED. THE FE REATTACHED THE COLLIMATOR AND VERIFIED FUNCTIONALITY.