CHROMOPHARE OR LIGHT CEILING-MOUNTED
Received Apr 16, 2021 · Event occurred Mar 2, 2021
Report 0008010153-2021-00001 · MDR key 11682269
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
[SUPPLEMENTAL 001] FIELD D4 WAS UPDATED TO CORRECT SERIAL NUMBER. FIELD G6 WAS UPDATED TO 'FOLLOW-UP REPORT # 001.' FIELD H2 WAS UPDATED TO 'CORRECTION.'
Description of Event or Problem
IT WAS REPORTED THE OR 2 LIGHT WON'T CONTROL FROM THE WALL. THERE WERE NO REPORTED INJURIES OR ADVERSE CONSEQUENCES.
Additional Manufacturer Narrative
IT WAS REPORTED THAT THERE WAS A LOSS OF CONTROL OF THE LIGHT HEAD. WHEN THE STRYKER FIELD SERVICE TECHNICIAN WENT ONSITE HE FOUND THAT THE SPANNER NUT AND C-LIP WERE MISSING. THERE WAS NO PATIENT INVOLVEMENT OR INJURY REPORTED; THE SEVERITY IS S0 PER (B)(4) . IT IS UNKNOWN HOW THE C-CLIP AND SPANNER NUT ARE MISSING; POTENTIAL REASONS INCLUDE INCORRECT ASSEMBLY DURING MANUFACTURING AND UNAUTHORIZED FIELD MODIFICATION. (B)(4) IS OPEN TO ADDRESS THIS ISSUE.
Description of Event or Problem
IT WAS REPORTED THE OR 2 LIGHT WON'T CONTROL FROM THE WALL. THERE WERE NO REPORTED INJURIES OR ADVERSE CONSEQUENCES.