CADD COMMUNICATION MODULE
Received Feb 13, 2025 · Event occurred Jan 14, 2025
Report 3012307300-2025-01840 · MDR key 21381232
Device
Generic name
Accessories, Pump, Infusion
Manufacturer
Icu Medical, Inc.Catalog number
21-2131-01
Lot number
19788478
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
H3: DEVICE NOT RECEIVED BY MANUFACTURER. 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 SOME MODULES FAILED TO RECONNECT WHEN POWERED UP FOR GO-LIVE, THEY PRODUCE ¿POOR CONNECTION TO MODULE¿ RED-SCREEN ERRORS OR PUMPS BOOT UP AND SHOW NO CHARGE. THERE WAS NO PATIENT INVOLVEMENT.
Additional Manufacturer Narrative
A1 - PATIENT IDENTIFIER WAS UPDATED. D3 - MFR ESTABLISHMENT NAME: UPDATED. NO PRODUCT WAS RETURNED. THE REPORTED ISSUE CANNOT BE CONFIRMED AS NO PRODUCT WAS RETURNED FOR INVESTIGATION. IF THE PRODUCT IS RETURNED, THIS COMPLAINT WILL BE REOPENED FOR FURTHER INVESTIGATION. A DEVICE HISTORY RECORD (DHR) REVIEW WAS CONDUCTED WHICH INDICATED ALL INSPECTIONS WERE COMPLETED AND NO ISSUES WERE NOTED DURING MANUFACTURE.