SCANX
Received Sep 9, 2014 · Event occurred Jan 3, 2013
Report 2428225-2014-00003 · MDR key 4105448
Device
Generic name
Digital Imaging System
Manufacturer
Air Techniques, Inc.Model number
D1000KCatalog number
D1000K
Lot number
NA
Product problems
- Loose or Intermittent Connection
- Component Missing
Patient
Not reported
- No Known Impact Or Consequence To Patient
Narrative
Description of Event or Problem
COMPLAINT WAS RECEIVED FOR A SCANX DUO ((B)(4), DATE OF MFR, 01/21/2011). THE IMPLICATED SCANX DUO WAS MANUFACTURED 01/21/2011 AND HAS BEEN IN SERVICE FOR TWO YEARS. OBSERVATIONS: THE UNIT WAS TAMPERED WITH BECAUSE WE OBSERVED THAT THE BOTTOM FUSE TAB WAS MISSING. THE REAR COVER SCREWS WERE LOOSE. THE MAIN PCB WAS INSPECTED AND THERE WERE NO VISIBLE BURN MARKINGS OR BURNT COMPONENTS. THE INTERNAL POWER SUPPLY WAS REMOVED AND THERE WAS A BURN MARK ON THE MAIN CAVITY NEXT TO IT. THE IMPLICATED UNIT WAS IN USE FOR NEARLY TWO YEARS WHEN THE INTERNAL POWER SUPPLY FAILED, RENDERING THE UNIT INOPERABLE. THE FAILURE OF THE POWER SUPPLY IS DEEMED AN ISOLATED INCIDENT.