inforMED
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

Generic name

Digital Image Storage

Manufacturer

Gyrus Acmi, Inc.

Model number

ISM-1007409-DEMO

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.