MalfunctionFSY
CHROMOPHARE OR LIGHT CEILING-MOUNTED
Received May 5, 2020 · Event occurred Apr 23, 2020
Report 0008010153-2020-00004 · MDR key 10024241
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 Patient Involvement
- No Patient Involvement
Narrative
Additional Manufacturer Narrative
IT WAS REPORTED THAT THE BLUE CIRCULAR DOME ON THE BACK OF THE F GEN LIGHT HEAD DISENGAGED OUTSIDE OF A CASE. THERE WERE NO REPORTED INJURY OR ADVERSE CONSEQUENCES. THE SEVERITY OF THIS CASE IS LOW, S0, PER RSK12227. (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 IN OR 3, A BLUE DOME FELL OFF AN F528 LIGHT. THERE WAS NO PATIENT INVOLVEMENT OR ANY REPORTED ADVERSE CONSEQUENCES.