MalfunctionMYN
POWERLOOK AMP WITH SECONDLOOK DIGITAL GE
Received Jan 11, 2018 · Event occurred Dec 14, 2017
Report 1225671-2018-00001 · MDR key 7183668
Device
Generic name
Secondlook Digital
Manufacturer
Icad, IncorporatedModel number
V7.2Catalog number
DSC010-01-US
Product problems
- Problem with Software Installation
- Problem with Software Installation
Patient
Not reported
- No Known Impact Or Consequence To Patient
- No Known Impact Or Consequence To Patient
Narrative
Additional Manufacturer Narrative
THE OEM FIELD SERVICE ENGINEER RETURNED TO CUSTOMER SITE AND INSTALLED THE CAD LICENSE AND THE SYSTEM IS WORKING PROPERLY.
Description of Event or Problem
A CUSTOMER SITE INDICATED THAT NO CAD MARKINGS WERE REPORTED FROM THE CAD AFTER PROCESSING PATIENT IMAGES. THE OEM MAMMOGRAPHY FIELD SERVICE ENGINEER (FSE) DID NOT APPLY THE CAD LICENSE AFTER INSTALLING THE CAD SOFTWARE. THIS RESULTED IN THE SITE NOT HAVING CAD MARKS ON CASES FOR SOME TIME. NO PATIENT INJURY OR ADVERSE EVENT WAS ASSOCIATED WITH THIS INCIDENT.
Remedial action
- Other