MalfunctionIZW
ULTRANET S
Received May 30, 2007 · Event occurred Apr 15, 2007
Report 9611343-2007-00043 · MDR key 857438
Device
Product problems
- Detachment Of Device Component
- Component Falling
Patient
YR
- Injury
Narrative
Additional Manufacturer Narrative
THE ROOT CAUSE OF THE EVENT WAS THREE OF THE SIX SCREWS USED TO HOLD THE COLLIMATOR WERE MISSING. THERE IS DOCUMENTATION IN THE SERVICE MANUAL INSTRUCTING THE PERIODIC CHECKING OF THE FASTENERS HOLDING THE COLLIMATOR. ATTEMPTS WERE MADE TO GET THE PATIENT INFORMATION, THEY WERE UNSUCCESSFUL.
Description of Event or Problem
IT WAS REPORTED THAT THE COLLIMATOR FELL FROM THE X-RAY ASSEMBLY AND WAS CAUGHT BY THE XR TECHNOLOGIST WHO REPORTED A SPRAINED HAND. THE CONCERN IS THAT IF THE EVENT WERE TO RECUR, SERIOUS INJURY MAY RESULT.