MalfunctionFSY
CHROMOPHARE OR LIGHT CEILING-MOUNTED
Received Jun 22, 2021 · Event occurred May 26, 2021
Report 0008010153-2021-00003 · MDR key 12040484
Device
Generic name
Light, Surgical, Ceiling Mounted
Manufacturer
Berchtold Gmbh & Co. KgModel number
CH00000001Catalog number
CH00000001
Product problems
- Material Separation
- Material Separation
Patient
Not reported
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
IT WAS REPORTED THAT THE COVER SEPARATED FROM AN F GENERATION LIGHT. THE LIGHT HEAD REPORTED IS WITHIN THE SCOPE OF PFA1937561 AND WILL BE HANDLED ACCORDINGLY. THERE WAS NO PATIENT INVOLVEMENT, NO INJURIES, NO ADVERSE CONSEQUENCES OR DELAY. PER RSK12227 REVISION E, THE SEVERITY IS S0.
Description of Event or Problem
IT WAS REPORTED THE DOME COVER FELL OFF IN R&D 2. THERE WERE NO REPORTED INJURIES.