MalfunctionLMB
NCARE, REC, DUAL, 2 DIR SDI, DEMO
Received Jun 5, 2026 · Event occurred May 8, 2026
Report 3011050570-2026-00620 · MDR key 25408730
Device
Product problems
- Unexpected Shutdown
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
THE CUSTOMER REPORTED THAT THE MONITOR TURNED OFF ON ITS OWN DURING AN UNSPECIFIED DIAGNOSTIC PROCEDURE INVOLVING AN OLYMPUS DIGITAL IMAGE STORAGE. THE PROCEDURE WAS COMPLETED WITH THE SAME DEVICE. THERE WAS NO PATIENT HARM.
Additional Manufacturer Narrative
THE INVESTIGATION IS ONGOING. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE INVESTIGATION IS COMPLETED OR IF ADDITIONAL INFORMATION BECOMES AVAILABLE.