inforMED
MalfunctionFSY

CHROMOPHARE OR LIGHT CEILING-MOUNTED

Received Aug 31, 2021 · Event occurred Aug 2, 2021

Report 0008010153-2021-00007 · MDR key 12397980

Device

Generic name

Light, Surgical, Ceiling Mounted

Model number

CH00000001

Catalog number

CH00000001

Product problems

  • Mechanical Problem
  • Mechanical Problem

Patient

Not reported

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

Narrative

Additional Manufacturer Narrative

IT WAS REPORTED THE BLUE DOME SEPARATED FROM THE LIGHT HEAD OUTSIDE OF A CASE. THERE WAS NO REPORTED PATIENT INVOLVEMENT, INJURIES, OR ADVERSE CONSEQUENCES. THE ROOT CAUSE OF THIS IS DUE TO THE LACK OF ADHESION BETWEEN THE BLUE DOME AND THE PLASTIC PORTION OF THE LIGHT HEAD COVER.

Description of Event or Problem

IT WAS REPORTED THE OR 1 BLUE DOME COVER COMING OFF OF LIGHT HEAD. THERE WERE NO REPORTED INJURIES OR ADVERSE CONSEQUENCES.