CHROMOPHARE OR LIGHT CEILING-MOUNTED
Received Jan 11, 2022 · Event occurred Dec 13, 2021
Report 0008010153-2022-00001 · MDR key 13233178
Device
Generic name
Light, Surgical, Ceiling Mounted
Manufacturer
Berchtold Gmbh & Co. KgModel number
CH00000001Catalog number
CH00000001
Product problems
- Material Separation
- Material Separation
Patient
Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
IT WAS REPORTED THAT THE BLUE DOME SEPARATED FROM AN F GENERATION LIGHT. THERE WAS NO PATIENT INVOLVEMENT, NO INJURIES, NO ADVERSE CONSEQUENCES OR DELAY. PER RSK (B)(4) REVISION P, THE SEVERITY IS S0. IF ANY FURTHER INFORMATION IS OBTAINED, A SUPPLEMENTAL WILL BE FILED.
Description of Event or Problem
IT WAS REPORTED AN OR 9 BLUE DOME HAS COME OFF OF THE LIGHT HEAD. THERE WERE NO REPORTED INJURIES OR ADVERSE CONSEQUENCES.
Description of Event or Problem
IT WAS REPORTED AN OR 9 BLUE DOME HAS COME OFF OF THE LIGHT HEAD. THERE WERE NO REPORTED INJURIES OR ADVERSE CONSEQUENCES.
Additional Manufacturer Narrative
[SUPPLEMENTAL 001] THE DEVICE WAS EVALUATED AND THE SERIAL NUMBER WAS CONFIRMED WITHIN SCOPE OF PFA1937561 AND WAS HANDLED ACCORDINGLY. FIELD H3 HAS BEEN UPDATED WITH 'YES' DEVICE WAS EVALUATED. FIELD D4 HAS BEEN UPDATED WITH THE SERIAL NUMBER. FIELD H9 HAS BEEN UPDATED WITH THE CORRECTION/REMOVAL RPT NUMBER.