MalfunctionKZF
SUNNEX CSTAR
Received Mar 29, 2021 · Event occurred Jan 19, 2021
Report 1226700-2021-00001 · MDR key 11585790
Device
Product problems
- No Apparent Adverse Event
- No Apparent Adverse Event
Patient
Not reported
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
SUNNEX HAS BEEN IN CONTACT WITH THE USER FACILITY AND IS WORKING WITH THEM. AN INVESTIGATION HAS BEGUN AND SUNNEX IS ANTICIPATING RECEIVING THE LIGHT BACK FOR EVALUATION AND INSPECTION. NO PATIENT INFORMATION WAS PROVIDED BY THE USER FACILITY. NO ONE WAS INJURED DUE TO THIS EVENT.
Description of Event or Problem
MRI LIGHT WAS ATTRACTED TO THE MRI MACHINE.