inforMED
MalfunctionKPQ

SIMVIEW NT

Received Sep 23, 2019 · Event occurred Sep 2, 2019

Report 3002466018-2019-96544 · MDR key 9105397

Device

Generic name

System, Simulation, Radiation Therapy

Model number

5497016

Product problems

  • Use of Device Problem
  • Unintended Movement
  • Use of Device Problem
  • Unintended Movement

Patient

Not reported

  • No Consequences Or Impact To Patient
  • No Consequences Or Impact To Patient

Narrative

Additional Manufacturer Narrative

SIEMENS COMPLETED AN INVESTIGATION OF THE REPORTED EVENT. THE SIMVIEW NT REACHED END OF SUPPORT SEVERAL YEARS AGO. THE SIEMENS SERVICE ENGINEER INSPECTED THE DEVICE FOR ANY DAMAGE CAUSED BY THE EVENT AND DID NOT FIND ANY DAMAGE. IF THE USER IS NOT AWARE THAT SAFETY IS A PRIORITY WHILE OPERATING THE SIMVIEW NT AND DOES NOT OBSERVE THE SPECIFIC WARNINGS CONTAINED IN THE USER MANUAL, SERIOUS INJURY CAN OCCUR BY COLLISION. THE ROOT CAUSE OF THE REPORTED EVENT IS UNKNOWN. IT IS NOT KNOWN AT THIS TIME IF THE EVENT OCCURRED DUE TO USER ERROR OR DEVICE FAILURE.

Description of Event or Problem

IT WAS REPORTED TO SIEMENS THAT THE SIMVIEW NT DETECTOR TOUCHED THE FLOOR DURING OPERATION. THERE WAS NO REPORT OF PATIENT MISTREATMENT OR INJURY ASSOCIATED WITH THE REPORTED EVENT. IF THE USER IS NOT AWARE THAT SAFETY IS A PRIORITY WHILE USING THE SIMVIEW NT AND DOES NOT OBSERVE THE SPECIFIC WARNINGS CONTAINED IN THE SYSTEM USER MANUAL, SERIOUS INJURY COULD OCCUR IF THE GANTRY OR COLLIMATOR ASSEMBLY COLLIDES WITH THE PATIENT. THE REPORTED EVENT OCCURRED IN (B)(6).