CADD SOLIS COMM MODULE
Received Jan 6, 2025 · Event occurred Dec 9, 2024
Report 3012307300-2025-00251 · MDR key 21078942
Device
Product problems
- Intermittent Communication Failure
- Intermittent Communication Failure
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
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 INFORMATION BECOMES AVAILABLE.
Description of Event or Problem
IT WAS REPORTED THAT THE COMMUNICATION MODULE EXHIBITED INTERMITTENT SIGNAL. THERE WAS UNKNOWN PATIENT INVOLVEMENT AND NO PATIENT HARM/ADVERSE EVENT WAS REPORTED.
Additional Manufacturer Narrative
D9: DATE RETURNED TO MFG.: 6/16/2025. D3 - MFG ESTABLISHMENT NAME, H3 AND H6. CODES: UPDATED. DEVICE EVALUATION: THE COMMUNICATION MODULE WAS RETURNED WITH NO VISUAL DAMAGE. THE CUSTOMER REPORTED ISSUE OF "THE COMMUNICATION MODULE HAD INTERMITTENT SIGNAL¿ WAS NOT CONFIRMED/DUPLICATED, AND A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED. UPON POWERING ON THE DEVICE, IT SUCCESSFULLY CONNECTED TO THE LOCAL WI-FI NETWORK. THE DEVICE REMAINED POWERED ON FOR 30 MINUTES WHILE THE WIRELESS STATUS WAS MONITORED, DURING WHICH IT CONSISTENTLY SHOWED AS "ASSOCIATED" WITH NO ERRORS REPORTED. THE ITEM IS A PURCHASED FINISHED GOOD, AND THE DEVICE HISTORY RECORD (DHR) IS WITH THE SUPPLIER THEREFORE, A MANUFACTURING REVIEW COULD NOT BE PERFORMED.