MalfunctionIZO
ANTHEM GENERATOR
Received Apr 15, 2019 · Event occurred Apr 28, 2016
Report 1418964-2019-00015 · MDR key 8513770
Device
Generic name
Radiographic Generator
Manufacturer
Del Medical Inc.Model number
ANTHEM 40-500Catalog number
110-5120G11
Lot number
NA
Product problems
- Arcing
- Arcing
Patient
29 YR
- Electric Shock
- Electric Shock
Narrative
Additional Manufacturer Narrative
DURING A RECENT FDA INVESTIGATION IT WAS OBSERVED THAT WE CHOSE NOT TO SUBMIT A MEDICAL DEVICE REPORT FOR THIS CUSTOMER COMPLAINT AS THE COMPLAINT COULD NOT BE SUBSTANTIATED BY OUR INVESTIGATION. WE ARE DUTIFULLY SUBMITTING THIS REPORT AS PART OF THE CONCLUSION FOR THIS OBSERVATION.
Description of Event or Problem
THE OPERATOR REPORTED TO HER MANAGER THAT AFTER OR DURING AN XRAY EXPOSURE SHE HEARD A BANG NOISE AND FELT SOME KIND OF SHOCK.