MalfunctionFSY
CHROMOPHARE OR LIGHT CEILING-MOUNTED
Received Jun 30, 2021 · Event occurred Jun 11, 2021
Report 0008010153-2021-00004 · MDR key 12092156
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 (B)(4) AND WILL BE HANDLED ACCORDINGLY. THERE WAS NO PATIENT INVOLVEMENT, NO INJURIES, NO ADVERSE CONSEQUENCES OR DELAY. PER (B)(4), THE SEVERITY IS S0.
Description of Event or Problem
IT WAS REPORTED THE LIGHT HEAD DOME COVERS IN CVOR W HAS POPPED OFF AND NEEDS TO BE REPLACED. IT WAS FURTHER REPORTED THE CORRECT LOCATION WAS CVOR X. THERE WERE NO REPORTED INJURIES OR ADVERSE CONSEQUENCES.