CADD SOLIS COMM MODULE

Description of Event or Problem

IT WAS REPORTED THAT THERE WAS AN ISSUE WITH THE WIRELESS COMMUNICATION MODULE. THERE WAS UNKNOWN PATIENT INVOLVEMENT AND UNKNOWN PATIENT HARM/ADVERSE EVENT REPORTED.

Additional Manufacturer Narrative

B3: DATE OF EVENT IS UNKNOWN; NO INFORMATION HAS BEEN PROVIDED TO DATE. INVESTIGATION INCLUDING ROOT CAUSE ANALYSIS IS IN PROGRESS. A SUPPLEMENTAL MDR WILL BE FILED AS NECESSARY IN ACCORDANCE WITH 21 CFR 803.56 WHEN ADDITIONAL REPORTABLE INFORMATION BECOMES AVAILABLE.

Additional Manufacturer Narrative

ONE DEVICE WAS RECEIVED FOR INVESTIGATION. THE REPORTED ISSUE WAS CONFIRMED DURING FUNCTIONAL TESTING WHEN THE REPORTED ISSUE WAS DUPLICATED. THE ISSUE WAS TRACED TO THE DEVICE COMMUNICATION MODULE, WHICH WAS DETERMINED TO BE FAULTY. THE PRODUCT'S HISTORY RECORDS WERE REVIEWED AND THERE WERE NO NON-CONFORMANCES NOR SERVICE-RELATED ISSUES THAT WOULD HAVE RESULTED IN THE REPORTED COMPLAINT. THE COMMUNICATION MODULE WAS REPLACED AND THE DEVICE PASSED ALL TESTING.