MalfunctionNSI
PILLCAM RECORDER
Received Dec 30, 2014 · Event occurred Jan 29, 2014
Report MW5039946 · MDR key 4387134
Device
Product problems
- Device Operates Differently Than Expected
Patient
76 YR
- No Information
Narrative
Description of Event or Problem
INDICATOR LIGHTS ON PILLCAM RECORDER WERE NOT ON. RECORDER RETURNED BY PATIENT TO ENDO DEPT. AND DATA RECORDER WAS OFF-REASON UNKNOWN. RECORDER RESTARTED WITHOUT DIFFICULTY. MANUFACTURER - GIVEN IMAGING STATES USER ISSUE.