inforMED
MalfunctionLMB

EASYSUITE 4K-2500 DUAL, IN ROOM&REMOTE

Received Apr 29, 2024 · Event occurred Apr 8, 2024

Report 3011050570-2024-00150 · MDR key 19202889

Device

Generic name

Digital Image Storage

Manufacturer

Gyrus Acmi, Inc.

Model number

ISM-1007372

Product problems

  • No Display/Image
  • No Display/Image

Patient

NA · Unknown

  • No Clinical Signs, Symptoms or Conditions
  • No Clinical Signs, Symptoms or Conditions

Narrative

Additional Manufacturer Narrative

THE EVALUATION OF THE EVENT IS ONGOING. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

Description of Event or Problem

IT WAS REPORTED THAT THE DIGITAL IMAGE STORAGE HAD NO IMAGE AND THE POWER BUTTON WAS BLINKING. THE ISSUE WAS FOUND DURING PREPARATION FOR USE IN A DIAGNOSTIC, UNSPECIFIED PROCEDURE. THE PROCEDURE WAS COMPLETED USING THE VIDEO TOWER. THERE WAS NO DELAY, AND THERE WERE NO REPORTS OF PATIENT HARM.