MalfunctionDXT
ANGIOMAT ILLUMENA
Received Apr 21, 2017 · Event occurred Mar 22, 2017
Report 1518293-2017-00015 · MDR key 6511056
Device
Product problems
- Break
Patient
Not reported
- No Known Impact Or Consequence To Patient
- No Known Impact Or Consequence To Patient
Narrative
Description of Event or Problem
INFORMATION RECEIVED FROM (B)(4) AFFILIATES. SUSPENSION ARM BROKEN. NO INJURIES. OPERATOR REPORTS THAT AFTER RELOADING THE INJECTOR, WAS PREPARING TO APPROACH THE INJECTOR TO THE PATIENT, AND THAT TIME THE ARM WITH THE INJECTOR MOUNTED TO THE CEILING HAS CAVED IN. NO FURTHER INFORMATION AVAILABLE AT THIS TIME. FOLLOW-UP INFORMATION IS REQUESTED WITH INVESTIGATION.