MIDMARK/PROGENY

Description of Event or Problem

ON SATURDAY (B)(6) AT APPROXIMATELY 3:00 PM CST WE HAD A SITUATION WITH TH EX-RAY ROOM WE HAD PURCHASED FORM QUANTUM I HAVE ATTACHED PICTURES FOR YOUR REVIEW. IT APPEARS THAT WHEN USING THE BOLTS SUPPLIED WITH THE COLLIMATOR THERE IS NOT ENOUGH TREADS IN THE TUBE PORT MOUNTING PLATE TO HOLD THE COLLIMATOR IN PLACE. IN THIS CASE THE BOLTS LET GO AND THE COLLIMATOR IN PLACE IN THIS CASE THE BOLTS LET GO AND THE COLLIMATOR FELL OFF. FORTUNATELY THERE WAS NOT A PATIENT UNDER THE COLLIMATOR SO NO ONE WAS HUT. THE SAME FIELD ENGINEERS INSTALLED THIS ROOM THAT HAVE DONE OVER 40 ROOMS IN THE LAST 4 TO 5 YEARS AND WE HAVE NEVER EXPERIENCED THIS BEFORE. I HAVE MANY MORE PICTURES AS WELL AS THE SERIAL NUMBERS OF THE TUBE AND COLLIMATOR. THE ISSUE IS THAT THE BOLTS ARE 1/4 TO 1/2 INCH SHORT IN LENGTH. SINCE THE OPERATOR HAD NOT CONTROL FOR THE TUBESTAND IS ALSO MOUNTED WITH THESE BOLTS THERE IS A CONSTANT PRESSURE APPLIED TO THESE BOLTS EVERY TIME THE TUBESTAND IS MOVED.

Additional Manufacturer Narrative

AFTER DISCUSSION WITH FIRM CONTRACTED WITH SYSTEM INSTALLATION, IT WAS CONCLUDED THAT THE REPORTED INCIDENT WAS A RESULT OF OVERSIGHT BY THE SYSTEM INSTALLATION STAFF INT HE PROPER SELECTION AND USE OF COLLIMATOR MOUNTING HARDWARE DURING SYSTEM SET-UP. REFER TO ATTACHED INVESTIGATION REPORT DATED (B)(4) 2014.