CADD SOLIS COMM MODULE

Additional Manufacturer Narrative

D4: EXPIRATION DATE AND H4: MANUFACTURE DATE ARE UNKNOWN, INVALID LOT NUMBER PROVIDED BY THE CUSTOMER. B3: DATE OF EVENT IS UNKNOWN; NO INFORMATION HAS BEEN PROVIDED TO DATE. H3: DEVICE NOT RETURNED TO MANUFACTURER. 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.

Description of Event or Problem

IT WAS REPORTED THAT THE WIRELESS MODULE HAD AN INTERMITTENT COMMUNICATION CONNECTION. THERE WAS UNKNOWN PATIENT INVOLVEMENT AND UNKNOWN PATIENT HARM/ADVERSE EVENT REPORTED.

Additional Manufacturer Narrative

H6: UPDATED. H3: ONE DEVICE WAS RECEIVED. DEVICE WAS VISUALLY INSPECTED AND IT WAS RECEIVED IN GOOD CONDITION WITH NO NOTICEABLE DAMAGE. DEVICE WAS TESTED ON KNOWN GOOD CADD DEVICE AND CONNECTED TO WI-FI AS EXPECTED WITH NO ALARMS OR ERRORS. CUSTOMER REPORTED COMPLAINT WAS UNABLE TO DUPLICATE AND A ROOT CAUSE WAS UNABLE TO BE DETERMINED. THE ITEM IS A PURCHASED FINISHED GOOD, AND THE DHR IS WITH THE SUPPLIER. THEREFORE, A MANUFACTURING BATCH REVIEW COULD NOT BE PERFORMED.