CADD-SOLIS WIRELESS COMMUNICATION MODULE
Received Mar 31, 2025 · Event occurred Mar 1, 2025
Report 3012307300-2025-03547 · MDR key 21734360
Device
Product problems
- Wireless Communication Problem
- Wireless Communication Problem
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
D3 - MFR ESTABLISHMENT NAME: CORRECTION H6. CODES: UPDATED. DEVICE EVALUATION: COMPLAINT FOR THE FAILURE MODE "DEVICE KEEPS SHOWING AN INTERMITTENT DISCONNECTION WITH THE COMMUNICATION MODULE MESSAGE WHEN IT IS TURNED ON" COULD NOT BE CONFIRMED AS NO SAMPLES OR PICTURES WERE PROVIDED BY THE CUSTOMER. WITHOUT THE RETURN OF THE SAMPLE(S) A COMPREHENSIVE FAILURE INVESTIGATION CANNOT BE PERFORMED, AND A PROBABLE CAUSE CANNOT BE DETERMINED. IF THE PRODUCT IS RETURNED THE MANUFACTURER WILL RE-OPEN THE COMPLAINT FOR FURTHER DEVICE ANALYSIS.
Additional Manufacturer Narrative
B3. DATE OF EVENT: MONTH AND YEAR OF EVENT HAVE BEEN PROVIDED, BUT DAY IS UNKNOWN.H3: 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 DEVICE KEEPS SHOWING AN INTERMITTENT DISCONNECTION WITH THE COMMUNICATION MODULE MESSAGE WHEN IT IS TURNED ON. TECH SUPPORT WAS CONTACTED, AND THEIR TROUBLESHOOTING TIPS WERE FOLLOWED. THE PROBLEM WAS NOT RESOLVED, INDICATING A POSSIBLY DAMAGED COMMUNICATION MODULE. THERE WAS UNKNOWN PATIENT INVOLVEMENT AND UNKNOWN PATIENT HARM/ADVERSE EVENT REPORTED.