SCANX CLASSIC ILE
Received May 30, 2018 · Event occurred Apr 26, 2018
Report 2428225-2018-00003 · MDR key 7554982
Device
Product problems
- Electrical /Electronic Property Problem
- Arcing
- Lack of Maintenance Documentation or Guidelines
- Electrical /Electronic Property Problem
- Arcing
- Lack of Maintenance Documentation or Guidelines
Patient
Not reported
- No Patient Involvement
- No Patient Involvement
Narrative
Additional Manufacturer Narrative
THE DEVICE WAS RETURNED WITHOUT THE POWER SUPPLY CORD SO A FULL EVALUATION COULD NOT BE CONDUCTED. THE POWER SUPPLY CORD CANNOT BE LOCATED.
Description of Event or Problem
THE HYGENIST AT THE DENTAL FACILITY NOTICED IN THE AFTERNOON THAT THE EXTERNAL POWER SUPPLY CORD ON THE BACK OF THE SCANX UNIT WAS SMOKING. UNIT WAS NOT BEING USED AT THAT TIME.
Description of Event or Problem
THE HYGIENIST AT THE DENTAL FACILITY NOTICED IN THE AFTERNOON THAT THE EXTERNAL POWER SUPPLY CORD ON THE BACK OF THE SCANX UNIT WAS SMOKING. UNIT WAS NOT BEING USED AT THAT TIME. NO ONE WAS HURT.
Additional Manufacturer Narrative
A DEVICE WAS SENT FOR FURTHER EVALUATION TO DETERMINE THE ROOT CAUSE.