MalfunctionFSY
CHROMOPHARE OR LIGHT CEILING-MOUNTED
Received Aug 31, 2021 · Event occurred Aug 4, 2021
Report 0008010153-2021-00006 · MDR key 12397748
Device
Generic name
Light, Surgical, Ceiling Mounted
Manufacturer
Berchtold Gmbh & Co. KgModel number
CH00000001Catalog number
CH00000001
Product problems
- Mechanical Problem
- Mechanical Problem
Patient
Not reported
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
IT WAS REPORTED THE BLUE DOME FELL OFF OF THE F-GEN LIGHT HEAD IN OR 1. THERE WERE NO REPORTED INJURIES OR ADVERSE CONSEQUENCES.
Additional Manufacturer Narrative
IT WAS REPORTED THAT THE BLUE DOME SEPARATED FROM AN F GENERATION LIGHT. THE LIGHT HEAD REPORTED IS WITHIN THE SCOPE OF (B)(4) AND WILL BE HANDLED ACCORDINGLY. THERE WAS NO REPORTED PATIENT INVOLVEMENT, NO INJURIES, NO ADVERSE CONSEQUENCES OR DELAY. PER (B)(4), THE SEVERITY IS S0.