CHROMOPHARE OR LIGHT CEILING-MOUNTED
Received Oct 9, 2020 · Event occurred Sep 14, 2020
Report 0008010153-2020-00008 · MDR key 10659225
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
Additional Manufacturer Narrative
IT WAS REPORTED THAT THE BLUE CIRCULAR DOME ON THE BACK OF THE F GEN LIGHT HEAD FELL OUTSIDE OF A CASE; THERE WERE NO REPORTED ADVERSE CONSEQUENCES. (B)(4) WERE OPENED TO REVIEW AND ADDRESS THIS ISSUE. THIS LIGHT IS WITHIN SCOPE OF THE FIELD ACTION.
Description of Event or Problem
IT WAS REPORTED THE BACK COVER FOR THE LIGHT CAME OFF EXPOSING THE WIRES AND MOTHERBOARD. THERE WERE NO REPORTED INJURIES OR PATIENT INVOLVEMENT.
Description of Event or Problem
IT WAS REPORTED THE BACK COVER FOR THE LIGHT CAME OFF EXPOSING THE WIRES AND MOTHERBOARD. THERE WERE NO REPORTED INJURIES OR PATIENT INVOLVEMENT.
Additional Manufacturer Narrative
THERE HAS BEEN A CORRECTED DATA UPDATE MADE TO THE FOLLOWING FIELD: RESULTS CODE GRID.