EASYSUITE 4K INTEGRATION SYS MODEL 1200
Received Apr 29, 2024 · Event occurred Apr 3, 2024
Report 3011050570-2024-00149 · MDR key 19202783
Device
Product problems
- Loss of Data
- Loss of Data
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
THIS SUPPLEMENTAL REPORT IS TO PROVIDE A CORRECTION TO THE INITIAL MEDWATCH REPORT (MDR). FURTHER REVIEW FOUND THERE WAS NO REPORTABLE MALFUNCTION RELATED TO THE SUBJECT DEVICE CAPTURED IN THIS COMPLAINT. THE INITIAL MDR WAS INADVERTENTLY SUBMITTED AS A REPORTABLE MALFUNCTION. THE INITIAL MEDWATCH REPORTED THAT THE SYSTEM LOST ALL THE VIDEOS AND THE INTEGRATION BOX IS VERY LOUD; HOWEVER, IT WAS CONFIRMED THAT THE CUSTOMER RESOLVED THE ISSUE AND REBOOTED WITH NO ISSUES. PER THE LEGAL MANUFACTURE, THIS ISSUE IS NOT LIKELY TO CAUSE OR CONTRIBUTE TO DEATH OR SERIOUS INJURY IF THE MALFUNCTION WERE TO RECUR.
Description of Event or Problem
IT WAS REPORTED THE INTEGRATION SYSTEM LOST ALL THE VIDEOS AND THE INTEGRATION BOX IS VERY LOUD. THE ISSUE OCCURRED DURING UNKNOWN. THERE WERE NO REPORTS OF PATIENT HARM.
Additional Manufacturer Narrative
THE CUSTOMER CONTACTED THE TECHNICAL ASSISTANCE CENTER (TAC) (OLYMPUS REPRESENTATIVE) EXPLAINING THAT THEY LOST ALL THE VIDEOS AND THE INTEGRATION BOX IS VERY LOUD. TAC REPRESENTATIVE STATED THAT HE CONTACTED THE CUSTOMER WHO INFORMED HIM THAT THE ISSUE HAS BEEN RESOLVED, BY REPLACING THE FAN / CLEANING THE DUST OFF OF FANS, REBOOTED WITH NO ISSUES. CUSTOMER RESOLVED, BY CLEANING / REPLACING THE FANS IN THE RACK. THE EVALUATION OF THE EVENT IS ONGOING. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.