MalfunctionEAT
VITALITY SCANNER 2006
Received Aug 6, 2014
Report 2016150-2014-00435 · MDR key 3985166
Device
Product problems
- Inappropriate/Inadequate Shock/Stimulation
Patient
46 YR
- Electric Shock
Narrative
Description of Event or Problem
A DOCTOR'S OFFICE ALLEGED THAT THE VITALITY SCANNER 2006 HAD SHOCKED A PATIENT DURING A PROCEDURE.
Additional Manufacturer Narrative
NO SERIOUS INJURY WAS ASSOCIATED WITH THIS INCIDENT. NO MEDICAL ATTENTION OR PRESCRIPTION MEDICATION WAS NECESSARY. NO SYMPTOMS WERE REPORTED BY THE PATIENT. TO DATE, THE PATIENT IS DOING FINE. A VISUAL AND PHYSICAL EVALUATION WAS PERFORMED ON THE RETURNED UNIT. IT WAS DISCOVERED THAT THE BATTERY SNAP WAS DISCONNECTED FROM THE UNIT AND THE WHEEL LABEL WAS COMING OFF.