CADD COMMUNICATION MODULE
Received Jun 5, 2025 · Event occurred May 1, 2025
Report 3012307300-2025-06643 · MDR key 22150477
Device
Generic name
Accessories, Pump, Infusion
Manufacturer
Icu Medical Asd, Inc.Product problems
- Battery Problem
- Battery Problem
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
IT WAS REPORTED THAT THE BATTERIES OF THE COMMUNICATION MODULE WERE DEPLETED. PATIENT INVOLVEMENT IS UNKNOWN.
Additional Manufacturer Narrative
B3: UNKNOWN. 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.
Additional Manufacturer Narrative
D3 - MFR ESTABLISHMENT NAME: CORRECTION H6. CODES: UPDATED. DEVICE EVALUATION: COMPLAINT FOR THE FAILURE MODE "DEPLETED COMM MODULE BATTERIES" 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. THIS MALFUNCTION DOES NOT AFFECT THE FUNCTION OF THE DEVICE IN A WAY THAT WOULD RESULT IN DEATH OR SERIOUS INJURY.