MalfunctionLMB
IMAGE MANAGEMENT SYSTEM- EVOLUTION 4K
Received Oct 25, 2021
Report 1221934-2021-03116 · MDR key 12691833
Device
Product problems
- Computer Software Problem
- Display or Visual Feedback Problem
- Computer Software Problem
- Display or Visual Feedback Problem
Patient
Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
UDI: (B)(4). TO DATE THE DEVICE HAS NOT BEEN RETURNED. IF THE DEVICE OR FURTHER DETAILS ARE RECEIVED AT A LATER DATE A SUPPLEMENTAL MEDWATCH WILL BE SENT.
Description of Event or Problem
IT WAS REPORTED BY THE AFFILIATE IN (B)(6) THAT THE IMAGE MANAGEMENT SYSTEM DEVICE HAD SOFTWARE ISSUE; AND THAT THERE WAS NO PICTURE SIGNAL. THERE WAS NO PROCEDURE NOR PATIENT INVOLVEMENT REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED. SOFTWARE ISSUE. NO.